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Brains Bioceutical s’apprête à obtenir l’une des premières certifications CEP pour le cannabidiol au monde auprès de la Direction européenne de la qualité du médicament et soins de santé

SANDWICH, Royaume–Uni, 23 août 2024 (GLOBE NEWSWIRE) — Brains Bioceutical Corp. (BBC) a franchi une étape décisive en soumettant l’une des premières demandes de CEP (Certification de conformité) au monde pour sa substance pharmaceutique active (API) à base de cannabidiol (CBD) à la Direction européenne de la qualité du médicament et soins de santé (EDQM). Cette démarche historique démontre que le CBD de BBC répond aux normes les plus strictes de l’industrie en matière de cannabinoïdes de qualité pharmaceutique.

La CEP confirme que le CBD de BBC répond aux normes de la Pharmacopée européenne (Ph. Eur.), une reconnaissance cruciale pour les fabricants de produits pharmaceutiques en Europe, au Canada, en Australie, au Japon et aux États–Unis. Cette certification facilite les processus réglementaires et garantit une qualité, une uniformité et une sécurité élevées sur les marchés mondiaux.

Parmi les autres avantages de la CEP, citons :

  • Faciliter et simplifier les interactions entre les régulateurs et l’industrie, en veillant à ce que les substances utilisées dans la production pharmaceutique répondent aux normes de la Pharmacopée européenne et soient conformes à la législation européenne pertinente.
  • Faciliter la gestion des médicaments expérimentaux pour les produits médicinaux.
  • Compléter et rapprocher les monographies de la Pharmacopée européenne et les exigences des dossiers réglementaires pour les médicaments.
  • Faire le lien entre les autorités sanitaires et l’industrie, en améliorant la communication et la coopération.

Ricky Brar, PDG et président de Brains Bioceutical Corp. a souligné l’importance de cette certification dans la stratégie à long terme de l’entreprise. « L’obtention d’une CEP pour notre substance pharmaceutique active à base de cannabidiol est une étape cruciale dans notre stratégie pour devenir le leader du marché mondial des cannabinoïdes. Elle renforce notre engagement en faveur de la qualité et de l’innovation et permet à Brains Bio d’établir une nouvelle norme pour l’industrie. Il ne s’agit pas seulement de répondre aux exigences réglementaires, mais de les dépasser et d’établir une nouvelle référence en matière de produits cannabinoïdes de qualité pharmaceutique. »

Dean Billington, directeur de l’exploitation de Brains Bioceutical Corp. a ajouté : « Notre demande auprès de l’EDQM témoigne du travail acharné et du dévouement de notre équipe. La CEP nous offrira un avantage concurrentiel significatif, en garantissant que notre IPA de cannabidiol sera reconnu comme un ingrédient de premier ordre pour l’usage pharmaceutique. Nous sommes fiers d’être des pionniers dans ce secteur qui évolue rapidement et de rechercher l’excellence dans tous les aspects de nos activités. »

La demande mondiale de produits pharmaceutiques à base de cannabinoïdes reste soutenue, comme en témoigne Epidiolex, dont Jazz Pharmaceuticals prévoit qu’il générera un chiffre d’affaires d’environ 1,4 milliard de dollars en 2024 [1]. Cela reflète une croissance et une demande continues pour des produits pharmaceutiques à base de cannabinoïdes de haute qualité.

La procédure d’examen de l’EDQM, qui a débuté le 8 août 2024, durera environ 115 jours ouvrables. L’obtention d’une CEP confirmera que le CBD de Brains Bio répond aux exigences rigoureuses de la Ph. Eur.

Cette demande de CEP souligne la détermination sans faille de Brains Bio à établir de nouvelles normes pour l’industrie des cannabinoïdes. Elle vient s’ajouter aux licences de BPF et de substances contrôlées de l’UE dont dispose Brains Bio. En alignant son IPA CBD sur les critères rigoureux de la Pharmacopée européenne, Brains Bio participe non seulement au marché, mais façonne aussi activement son avenir.

Dans le cadre de notre partenariat stratégique, Brains Bioceutical et DSM–Firmenich ont uni leurs forces pour mettre à profit leur expertise combinée dans la recherche et le développement des cannabinoïdes. En collaboration avec Brains Bioceutical, fabricant de cannabinoïdes de qualité pharmaceutique, DSM–Firmenich offre une plateforme d’innovation de bout en bout conçue pour accompagner les premières étapes du développement de médicaments à base de cannabinoïdes et optimiser le potentiel des formulations à base de CBD. Cette plateforme offre une expertise de pointe en matière de formulation, un réseau mondial de spécialistes de la réglementation et des compétences en matière d’études précliniques et cliniques. L’entreprise est également en mesure de fournir des solutions personnalisées en fonction du domaine thérapeutique et de l’objectif de délivrance du médicament. Pour en savoir plus sur la façon dont la plateforme d’innovation des cannabinoïdes de DSM–Firmenich contribue à améliorer la santé des patients, visitez le site : www.dsm.com/cannabinoid–actives.

À propos de Brains Bioceutical Corp.

Brains Bioceutical est le leader des solutions de santé et de bien–être à base de plantes naturelles, fondées sur l’expérience clinique et la recherche scientifique.

Brains Bio est un fabricant de premier plan de substances pharmaceutiques actives (IPA) naturelles et pures de la plus haute qualité. Grâce à un ensemble unique de licences et de certifications, Brains Bio est stratégiquement positionné pour tirer parti de l’environnement réglementaire complexe, en garantissant son avantage en tant que pionnier et en termes de qualité des produits. Brains Bio a des activités diversifiées dans les secteurs pharmaceutiques, médicaux et nutraceutiques au sein du marché des cannabinoïdes, qui connaît une croissance rapide, ce qui lui confère une proposition de valeur forte et unique.

[1] https://investor.jazzpharma.com/investors

Une photo accompagnant cette annonce est disponible à l’adresse : https://www.globenewswire.com/NewsRoom/AttachmentNg/b460b7ca–9a31–4a41–a012–23d26e61ef5d


GLOBENEWSWIRE (Distribution ID 9219428)

Brains Bioceutical steht kurz vor Erhalt einer der weltweit ersten CEP-Zertifizierungen für Cannabidiol vom Europäischen Direktorat für die Qualität von Arzneimitteln und Gesundheitsfürsorge

SANDWICH, Vereinigtes Königreich, Aug. 23, 2024 (GLOBE NEWSWIRE) — Brains Bioceutical Corp. (BBC) hat einen bahnbrechenden Meilenstein erreicht, indem es einen der weltweit ersten CEP–Anträge (Eignungszertifikat) für seinen pharmazeutischen Wirkstoff Cannabidiol (CBD) beim Europäischen Direktorat für die Qualität von Arzneimitteln und Gesundheitsfürsorge (EDQM) eingereicht hat. Diese bahnbrechende Leistung zeigt, dass das CBD von BBC den höchsten Branchenstandard für Cannabinoidprodukte in pharmazeutischer Qualität erfüllt.

Die CEP–Zertifizierung bestätigt, dass das CBD von BBC den Standards des Europäischen Arzneibuchs (Ph. Eur.) entspricht, eine wichtige Bestätigung für Pharmahersteller in Europa, Kanada, Australien, Japan und den USA. Diese Zertifizierung vereinfacht die regulatorischen Prozesse und gewährleistet eine hohe Qualität, Konsistenz und Sicherheit für globale Märkte.

Zu den weiteren Vorteilen des CEP gehören:

  • Erleichterung und Vereinfachung der Interaktion zwischen Regulierungsbehörden und der Industrie, um sicherzustellen, dass die in der pharmazeutischen Produktion verwendeten Substanzen den Standards des Europäischen Arzneibuchs und den einschlägigen EU–Rechtsvorschriften entsprechen.
  • Erleichterung der Verwaltung von Prüfpräparaten für Arzneimittel.
  • Ergänzung und Brücke zwischen den Monografien des Europäischen Arzneibuchs und den Anforderungen an das Zulassungsdossier für Arzneimittel.
  • Bindeglied zwischen Gesundheitsbehörden und Industrie und Verbesserung der Kommunikation und Zusammenarbeit.

Ricky Brar, CEO und Vorstandsvorsitzender von Brains Bioceutical Corp., betonte die Bedeutung dieser Zertifizierung für die langfristige Strategie des Unternehmens. „Die Erlangung einer CEP–Zertifizierung für unseren aktiven pharmazeutischen Cannabidiol–Wirkstoff ist ein entscheidender Schritt auf unserem Weg, den globalen Cannabinoid–Markt anzuführen. Dies bestärkt uns in unserem Engagement für Qualität und Innovation und positioniert Brains Bio als Maßstab für die Branche. Hier geht es nicht nur darum, die gesetzlichen Anforderungen zu erfüllen – es geht darum, sie zu übertreffen und einen neuen Maßstab dafür zu setzen, wie Cannabinoidprodukte in pharmazeutischer Qualität aussehen sollten.“

Dean Billington, Chief Operating Officer von Brains Bioceutical Corp., fügte hinzu: „Unsere Einreichung beim EDQM ist ein Zeugnis für die harte Arbeit und das Engagement unseres Teams. Die CEP–Zertifizierung wird einen erheblichen Wettbewerbsvorteil bieten und sicherstellen, dass unser Cannabidiol–Wirkstoff als erstklassiger Inhaltsstoff für pharmazeutische Zwecke anerkannt wird. Wir sind stolz darauf, in dieser sich schnell entwickelnden Branche an vorderster Front zu stehen und in allen Aspekten unserer Geschäftstätigkeit Spitzenleistungen zu erbringen.“

Die weltweite Nachfrage nach Arzneimitteln auf Cannabinoidbasis ist nach wie vor hoch, wie das Beispiel Epidiolex zeigt, mit dem Jazz Pharmaceuticals im Jahr 2024 voraussichtlich einen Umsatz von etwa 1,4 Mrd. USD erzielen wird [1]. Dies spiegelt das anhaltende Wachstum und die Nachfrage nach hochwertigen pharmazeutischen Cannabinoidprodukten wider.

Der am 8. August 2024 eingeleitete Überprüfungsprozess des EDQM wird etwa 115 Arbeitstage dauern. Die erfolgreiche Erteilung einer CEP–Zertifizierung bestätigt, dass das CBD von Brains Bio die strengen Anforderungen des Ph. Eur. erfüllt.

Diese Bemühungen um die Zulassung von Cannabidiol unterstreichen das unerschütterliche Engagement von Brains Bio, neue Standards für die Cannabinoid–Branche zu setzen. Dies baut auf den EU–GMP– und den Lizenzen für kontrollierte Substanzen von Brains Bio auf. Durch die Anpassung seines CBD–Wirkstoffs an die strengen Kriterien des Europäischen Arzneibuchs nimmt Brains Bio nicht nur am Markt teil, sondern gestaltet dessen Zukunft aktiv mit.

Im Rahmen unserer strategischen Partnerschaft haben sich Brains Bioceutical und DSM–Firmenich zusammengeschlossen, um ihr gemeinsames Know–how in der Cannabinoid–Forschung und –Entwicklung zu nutzen. Zusammen mit Brains Bioceutical – einem Hersteller hochwertiger Cannabinoide in pharmazeutischer Qualität – bietet DSM–Firmenich eine umfassende Innovationsplattform an, die darauf ausgelegt ist, die Entwicklung von Cannabinoid–Arzneimitteln in der Anfangsphase zu unterstützen und das Potenzial von CBD–basierten Formulierungen auszuschöpfen. Zu den Kompetenzen des Unternehmens gehören modernste Formulierungskenntnisse, ein globales Netzwerk von Zulassungsspezialisten sowie die Durchführung präklinischer und klinischer Studien. Das Unternehmen ist auch in der Lage, maßgeschneiderte Lösungen je nach Therapiebereich und Ziel der Arzneimittelabgabe anzubieten. Weitere Informationen darüber, wie die Cannabinoid–Innovationsplattform von DSM–Firmenich zur Verbesserung der Gesundheit von Patienten beiträgt, finden Sie unter: www.dsm.com/cannabinoid–actives.

Über die Brains Bioceutical Corp.

Brains Bioceutical ist der führende Pionier im Bereich der Entwicklung von evidenzbasierten und wissenschaftlich fundierten natürlichen, pflanzlichen Gesundheits– und Wellnesslösungen.

Brains Bio ist ein führender Hersteller von natürlichen und reinen pharmazeutischen Wirkstoffen (APIs) höchster Qualität. Mit einem einzigartigen Paket an Lizenzen und Registrierungen ist Brains Bio strategisch positioniert, um das komplexe regulatorische Umfeld zu nutzen und sich seinen Vorsprung als Vorreiter und in der Produktqualität zu sichern. Brains Bio ist diversifiziert über die pharmazeutischen, medizinischen, und nutrazeutischen Sektoren innerhalb des schnell wachsenden Cannabinoidmarktes, was zu einem starken und einzigartigen Wertversprechen führt.

[1] https://investor.jazzpharma.com/investors

Ein Foto zu dieser Mitteilung ist verfügbar unter https://www.globenewswire.com/NewsRoom/AttachmentNg/b460b7ca–9a31–4a41–a012–23d26e61ef5d


GLOBENEWSWIRE (Distribution ID 9219428)

Brains Bioceutical Deve Obter o Primeiro Certificado CEP do Mundo para Canabinóides, do European Directorate de Qualidade de Medicamentos e Cuidados de Saúde

SANDWICH, Reino Unido, Aug. 22, 2024 (GLOBE NEWSWIRE) — A Brains Bioceutical Corp. (BBC) alcançou um marco inovador ao fazer um dos primeiros pedidos de CEP (Certificação de Adequação) do mundo para seu Ingrediente Farmacêutico Ativo (API) de Canabidiol (CBD) ao European Directorate para Qualidade de Medicamentos e Cuidados de Saúde (EDQM). Esta conquista histórica demonstra que o CBD da BBC atende ao mais alto padrão da indústria para produtos canabinóides de grau farmacêutico.

O CEP confirma que o CBD da BBC está em conformidade com a Farmacopeia Europeia (Ph. Eur.), um endosso crucial para fabricantes farmacêuticos da Europa, Canadá, Austrália, Japão e EUA. Esta certificação agiliza os processos regulatórios, garantindo alta qualidade, consistência e segurança para os mercados globais.

Outras vantagens do CEP incluem:

  • Facilitar e simplificar as interações entre os reguladores e a indústria, garantindo que as substâncias utilizadas na produção farmacêutica estejam em conformidade com as normas da Farmacopeia Europeia e a legislação pertinente da UE.
  • Facilitar o gerenciamento de medicamentos experimentais para produtos medicinais.
  • Servir de complemento e ponte entre as monografias da Farmacopeia Europeia e os requisitos do dossiê regulamentar para medicamentos.
  • Atuar como elo entre as autoridades de saúde e a indústria, potencializando a comunicação e a cooperação.

Ricky Brar, CEO e Presidente da Brains Bioceutical Corp., enfatizou a importância dessa certificação na estratégia de longo prazo da empresa. “A obtenção de um CEP para o nosso Ingrediente Farmacêutico Ativo de Canabidiol é um passo fundamental na nossa jornada para liderar o mercado global de canabinóides. Isto reforça o nosso compromisso para com a qualidade e a inovação, e posiciona a Brains Bio para definir o padrão para a indústria. Não se trata apenas de atender aos requisitos regulamentares – e sim de exceder e de estabelecer uma nova referência para os produtos canabinóides de grau farmacêutico.”

Dean Billington, Diretor de Operações da Brains Bioceutical Corp., acrescentou: “Nosso pedido junto ao EDQM é um testemunho do trabalho árduo e da dedicação da nossa equipe. O CEP nos dará uma vantagem competitiva significativa, garantindo que nosso API de Canabidiol seja reconhecido como um ingrediente de primeira linha para uso farmacêutico. Temos orgulho de estar na vanguarda desta indústria em rápida evolução e de impulsionar a excelência em todos os aspectos das nossas operações.”

A demanda global por produtos farmacêuticos com base em canabinóides permanece robusta, evidenciada pelo Epidiolex, que a Jazz Pharmaceuticals projeta gerar aproximadamente US $ 1,4 bilhão em receita em 2024 [1]. Isso demonstra o crescimento e a demanda contínuos de produtos farmacêuticos de canabinóides de alta qualidade.

O processo de análise da EDQM, iniciado em 8 de agosto de 2024, levará aproximadamente 115 dias úteis. O recebimento de um CEP confirmará que o CBD da Brains Bio atende às rigorosas exigências da Ph. Eur.

Esta solicitação de um CEP ressalta o compromisso inabalável da Brains Bio em estabelecer novos padrões para a indústria de canabinóides que se baseia nas BPF da UE e nas licenças de substâncias controladas da Brains Bio. Ao alinhar seu API CBD com os rigorosos critérios da Farmacopeia Europeia, a Brains Bio, além de participar do mercado molda ativamente seu futuro.

Como parte da nossa parceria estratégica, a Brains Bioceutical e a DSM–Firmenich uniram forças para alavancar sua experiência conjunta em pesquisa e desenvolvimento de canabinóides. Juntamente com a Brains Bioceutical – fabricante de canabinóides de alta qualidade de grau farmacêutico – a DSM–Firmenich oferece uma plataforma de inovação completa projetada para apoiar o desenvolvimento de medicamentos canabinóides em estágio inicial e realizar o potencial das formulações à base de CBD. Suas capacidades incluem experiência em formulação de ponta, uma rede global de especialistas em regulamentação e proficiência em estudos pré–clínicos e clínicos. A empresa também tem a capacidade de fornecer soluções personalizadas dependendo da área terapêutica e do objetivo de entrega do medicamento. Para mais informações sobre como a plataforma de inovação de canabinóides da DSM–Firmenich está ajudando a melhorar a saúde do paciente, visite: www.dsm.com/cannabinoid–actives.

Sobre a Brains Bioceutical Corp.

A Brains Bioceutical é líder em soluções de saúde e bem–estar com base em evidências e lideradas pela ciência.

A Brains Bio é fabricante líder de insumos farmacêuticos ativos (APIs) naturais e puros da mais alta qualidade. Com um conjunto exclusivo de licenças e registros, a Brains Bio está estrategicamente posicionada para aproveitar o complexo ambiente regulatório, garantindo sua vantagem de qualidade em primeiro lugar e produto. A Brains Bio é ativa nos setores farmacêutico, médico e nutracêutico dentro do mercado de canabinóides em rápido crescimento, sendo uma proposta de valor potente e única.

[1] https://investor.jazzpharma.com/investors

Foto deste comunicado disponível em https://www.globenewswire.com/NewsRoom/AttachmentNg/b460b7ca–9a31–4a41–a012–23d26e61ef5d


GLOBENEWSWIRE (Distribution ID 9219428)

Brains Bioceutical Set to Achieve One of the World’s First CEP for Cannabidiol Certification with the European Directorate for the Quality of Medicines & Healthcare

SANDWICH, United Kingdom, Aug. 22, 2024 (GLOBE NEWSWIRE) — Brains Bioceutical Corp. (BBC) has achieved a groundbreaking milestone by submitting one of the world’s first CEP (Certification of Suitability) application for its Cannabidiol (CBD) Active Pharmaceutical Ingredient (API) to the European Directorate for the Quality of Medicines & Healthcare (EDQM). This landmark achievement demonstrates BBC’s CBD as meeting the highest industry standard for pharmaceutical–grade cannabinoid products.

The CEP confirms that BBC’s CBD meets European Pharmacopoeia (Ph. Eur.) standards, a crucial endorsement for pharmaceutical manufacturers in Europe, Canada, Australia, Japan, and the US. This certification streamlines regulatory processes, ensuring high quality, consistency, and safety for global markets.

Additional advantages of the CEP include:

  • Facilitating and simplifying interactions between regulators and industry, ensuring that substances used in pharmaceutical production meet European Pharmacopoeia standards and comply with relevant EU legislation.
  • Easing the management of investigational medicinal product for medicinal products.
  • Serving as a complement and bridge between European Pharmacopoeia monographs and the regulatory dossier requirements for medicinal products.
  • Acting as a link between health authorities and industry, enhancing communication and cooperation.

Ricky Brar, CEO and Chairman of Brains Bioceutical Corp., emphasized the importance of this certification in the company’s long–term strategy. “Achieving a CEP for our Cannabidiol Active Pharmaceutical Ingredient is a pivotal step in our journey to lead the global cannabinoid market. It reinforces our commitment to quality and innovation, and it positions Brains Bio to set the standard for the industry. This is not just about meeting regulatory requirements—it's about exceeding them and setting a new benchmark for what pharmaceutical–grade cannabinoid products should be.”

Dean Billington, Chief Operating Officer of Brains Bioceutical Corp., added, “Our submission to the EDQM is a testament to the hard work and dedication of our team. The CEP will provide a significant competitive advantage, ensuring that our Cannabidiol API is recognized as a top–tier ingredient for pharmaceutical use. We are proud to be at the forefront of this rapidly evolving industry, driving excellence in every aspect of our operations.”

The global demand for cannabinoid–based pharmaceuticals remains robust, evidenced by Epidiolex, which Jazz Pharmaceuticals projects will generate approximately $1.4 billion in revenue in 2024 [1]. This reflects ongoing growth and demand for high–quality pharmaceutical cannabinoid products.

The EDQM’s review process, initiated on August 8, 2024, will take approximately 115 working days. Successful granting of a CEP will confirm that Brains Bio’s CBD meets, the stringent Ph. Eur. requirements.

This CEP application effort underscores Brains Bio’s unwavering commitment to setting new standards for the cannabinoid industry. This builds on Brains Bio’s EU GMP and controlled substances licenses. By aligning its CBD API with the rigorous criteria of the European Pharmacopoeia, Brains Bio is not only participating in the market but actively shaping its future.

As part of our strategic partnership, Brains Bioceutical and DSM–Firmenich have joined forces to leverage their combined expertise in cannabinoid research and development. Together with Brains Bioceutical – manufacturer of high–quality pharma–grade cannabinoids – DSM–Firmenich offers an end–to–end innovation platform designed to support early–stage cannabinoid drug development and realize the potential of CBD– based formulations. Its capabilities include leading–edge formulation expertise, a global network of regulatory specialists, and preclinical and clinical study proficiency. The company also has the capacity to provide customized solutions depending on the therapeutic area and drug delivery objective. To learn more about how DSM–Firmenich’s cannabinoid innovation platform is helping to elevate patient health, visit: www.dsm.com/cannabinoid–actives.

About Brains Bioceutical Corp.

Brains Bioceutical is the leader in evidence–based and science–led pioneer of natural plant–based health and wellness solutions.

Brains Bio is a leading manufacturer of the highest quality natural and pure active pharmaceutical ingredients (APIs), with a unique suite of licenses and registrations, Brains Bio is strategically positioned to take advantage of the complex regulatory environment, securing its first mover and product quality advantage. Brains Bio is diversified across the pharmaceutical, medical, and nutraceutical sectors within the rapidly growing cannabinoid market, resulting in a strong and unique value proposition.

[1] https://investor.jazzpharma.com/investors

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b460b7ca–9a31–4a41–a012–23d26e61ef5d


GLOBENEWSWIRE (Distribution ID 9218790)

Entera Bio Reports Q2 2024 Financial Results and Provides Business Updates

JERUSALEM , Aug. 09, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and small therapeutic proteins, today reported financial results and key business updates for the quarter ended June 30, 2024.

“We continue to deliver strong execution with key milestones achieved during the second quarter of 2024 across each of our N–Tab™ oral peptide programs dedicated to patients with OBGYN/endocrinology, GI and metabolic diseases,” said Miranda Toledano, Entera’s CEO. “Importantly, we are now just five months away from FDA’s potential landmark ruling on the ASBMR–FNIH SABRE regulatory endpoint for osteoporosis drugs, which we view as a major catalyst for EB613. We are especially keen to start our pivotal study of EB613 in a much wider population where injectable anabolic drugs do not play a dominant role. Because of its potential dual mechanism of action, faster onset of action as an anabolic boosting agent and oral minitablet format, we believe EB613 is uniquely positioned to support earlier osteoanabolic intervention in post–menopausal women at high risk of fracture,” she added.

EB613: First Oral PTH(1–34) Daily Osteoanabolic Tablets for Osteoporosis

  • In April 2024, the Journal of Bone and Mineral Research (JBMR) published “Oral daily PTH(1–34) Tablets [EB613] in Postmenopausal Women with Low BMD or Osteoporosis: A Randomized, Placebo–Controlled, 6–Month, Phase 2 Study”
  • In May 2024, Entera welcomed Dr. Rachel Wagman as Key Clinical Advisor to lead EB613 clinical development. Wagman has successfully advanced the development of five molecules, including the osteoporosis products Forteo®, Prolia® and Evenity® through registration
  • In June 2024, the JMBR published an independent editorial titled “A Novel Oral hPTH(1–34) [EB613] Unveils the Promise of Modeling–Based Anabolism with No Increase in Bone Remodeling”
  • In July 2024, Entera announced that new comparative pharmacological data for its investigational agent EB613 vs. Forteo® was selected for presentation at the ASBMR September 2024 Annual Meeting in Toronto
  • In July 2024, Entera announced that the SABRE (Study to Advance BMD as a Regulatory Endpoint) is expected to provide an update at the ASBMR September 2024 Annual Meeting in Toronto

EB612: First Oral PTH(1–34) Peptide Replacement Therapy Tablets for Hypoparathyroidism

  • In June 2024, Entera presented Phase 1 clinical data for its hypoparathyroidism focused investigational program, EB612, at the Endocrine Society ENDO 2024 Annual Meeting. Entera showed that the data supports potentially moving the BID (twice–daily) tablet dose to Phase 2 development in patients with hypoparathyroidism
  • Entera continues to collaborate with a third party on the development of another PTH replacement treatment for hypoparathyroidism

First GLP–2 Peptide Tablets for Short Bowel Syndrome

  • In March 2024, Entera announced positive in vivo PK results from its program combining OPKO Health, Inc.’s (Nasdaq: OPK) long acting GLP–2 analogue with N–Tab™ technology. Pharmacology data is expected early in the second half of 2024

First GLP–1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity

  • Collaborative work is ongoing combining N–Tab™ with OPKO’s long–acting Oxyntomodulin (OXM) analogues for potential treatment for obesity and other metabolic diseases. PK data for the oral OXM tablet are expected early in the second half of 2024

Financial Results for the Quarter Ended June 30, 2024

As of June 30,2024, Entera had cash and cash equivalents of $9.1 million. The Company expects that its existing cash resources are sufficient to meet its projected operating requirements into the third quarter of 2025.

Research and development expenses for the three months ended June 30, 2024 were $1.1 million, as compared to $1.2 million for the three months ended June 30, 2023. The decrease of $0.1 million was primarily due to a decrease of $0.3 million in clinical expenses for our Phase 1 PK study related to our new generation platform and new formulations for EB612, which completed its first stage in 2023.

General and administrative expenses for both the three months ended June 30, 2024 and 2023 were $1.1 million.

Operating expenses for the period ended June 30, 2024 were $2.2 million, as compared to $2.3 million for the quarter ended June 30, 2023.

Net loss was $2.1 million, or $0.06 per ordinary share (basic and diluted), for the quarter ended June 30, 2024, as compared to $2.3 million, or $0.08 per ordinary share (basic and diluted), for the quarter ended June 30, 2023.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

ENTERA BIO LTD.
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
 
  June 30,   December 31,
  2024   2023
  (Unaudited)   (Audited)
   
Cash and cash equivalents 9,056   11,019
Accounts receivable and other current assets 539   238
Property and equipment, net 76   100
Other assets, net 364   408
Total assets 10,035   11,765
       
       
Accounts payable and other current liabilities 1,294   1,091
Total non–current liabilities 219   288
Total liabilities 1,503   1,379
Total shareholders' equity 8,532   10,386
       
Total liabilities and shareholders' equity 10,035   11,765
 

ENTERA BIO LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
 
  Three Months Ended
June 30,
  2024   2023  
REVENUES 57   –  
COST OF REVENUES 48   –  
GROSS PROFIT 9   –  
OPERATING EXPENSES:    
Research and development 1,086   1,209  
General and administrative 1,088   1,135  
Other income –   (14)  
TOTAL OPERATING EXPENSES 2,174   2,330  
OPERATING LOSS 2,165   2,330  
FINANCIAL INCOME, NET (20)   (5)  
NET LOSS 2,145   2,325  
     
LOSS PER SHARE BASIC AND DILUTED 0.06   0.08  
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING         
USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE 37,090,160   28,812,375  
     


GLOBENEWSWIRE (Distribution ID 9202470)

Entera’s EB613, the First Once Daily PTH(1-34) Tablet Treatment Dedicated to Post-Menopausal Women with High Risk Osteoporosis Abstract Selected for Presentation at the ASBMR 2024 Annual Meeting – Key SABRE Update Also Expected

JERUSALEM, Aug. 01, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of orally delivered peptides and therapeutic proteins, today announced that new comparative pharmacological data for its investigational agent EB613 vs. Forteo® was selected for presentation at the American Society for Bone and Mineral Research (ASBMR) 2024 Annual Meeting which will be held on September 27–30, 2024 in Toronto, ON, Canada.

EB613 is being developed as the first once–daily oral anabolic (bone forming) PTH(1–34) mini tablet therapy for post–menopausal women with high risk osteoporosis. It is estimated that 50 percent of women and 20 percent of men over the age of 50 are at risk of a fragility fractures and approximately 1 in 5 adults will die within the year following a hip fracture. Post menopausal osteoporosis afflicts more women than cancer and cardiovascular disease and is a serious health concern for an estimated 200 million women globally.

“Available injectable anabolic treatments, while efficacious and recommended across medical guidelines, unfortunately do not provide a viable solution for most women with high–risk osteoporosis requiring an anabolic intervention. Our EB613 program is dedicated to address the treatment chasm in current osteoporosis care and hopefully present a treatment for the majority of women to adequately manage their post–menopause bone health with a simple once daily tablet treatment. Importantly, we look forward to the SABRE (Study to Advance BMD as a Regulatory Endpoint) UPDATE at the ASBMR 2024 meeting. On March 26th 2024, Entera echoed the ASBMR announcement that the U.S. Food and Drug Administration (FDA) had communicated to SABRE that a ruling to qualify bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti–osteoporosis drugs would be provided within 10 months. The proposed registrational Phase 3 study for EB613, is designed to meet the quantitative BMD thresholds proposed by SABRE,” said Miranda Toledano, Chief Executive Officer at Entera.

Abstract Title:  3079 – EB613 (Oral PTH(1–34) Tablets) Shows Differentiated Pharmacokinetic Profile From Forteo – New Results from Phase 1b Open–Label Study
Presentation Number:  Sat–LB 589
Session Date/Time: Saturday, September 28, 2024, 2:15 – 3:45 PM 

SABRE Project Update

Speakers: Dennis M. Black , PhD, University of California, United States; Theresa E. Kehoe , MD, CDER/FDA, United States

Session Date / Time: Sunday September 29, 2024 9:45 – 10:45 AM

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this press release are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as the company’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9197414)

Policymakers should recognise #SelfCareIsHealthcare in campaign bid to address global health challenges

  • Self–care describes the role of individuals in preventing disease, promoting and maintaining their mental and physical health, and actively participating in their healthcare
  • A wealth of evidence demonstrates the significant value of self–care to individuals, health systems, society and the economy

  • Despite this, self–care is not universally viewed or understood as a healthcare intervention and there is unequal access to self–care interventions around the world

GENEVA, July 24, 2024 (GLOBE NEWSWIRE) — The Global Self–Care Federation (GSCF) is urgently calling upon policymakers and health leaders worldwide to embrace self–care as an essential component of healthcare, by ensuring it is fully integrated into national health systems and policies, as part of this year’s International Self–Care Day on July 24.

The concept of self–care was first recognised by the World Health Organization (WHO) in 1983. It describes the role of individuals in preventing disease, promoting and maintaining their mental and physical health, and actively participating in their healthcare. Examples of self–care practices include medicines, devices, diagnostics digital tools as well as healthy lifestyle choices.

As health systems worldwide continue to face a range of challenges – from increased demand on services, to inequity in access to healthcare – evidence shows that self–care can:

  • avert an estimated 3.9 million premature deaths each year, through physical activity alonei
  • save nearly $120 billion each year for global healthcare systems and, therefore, national economiesii
  • improve the autonomy and agency of disadvantaged groups, including women and girls, in managing their own healthiii
  • provide a legitimate tool in the pursuit of universal health coverageiv

Judy Stenmark, Director General of GSCF, said: “Right now, health systems around the world are struggling, long–term ill health is on the rise, health disparities are growing and the impact of COVID–19 is still being felt. Addressing these requires new approaches and strategies, including evidence–based self–care – to achieve sustainable health services fit for the future.

“Our ‘Self–care is healthcare’ campaign is all about fuelling the movement for self–care to be recognised as an integral part of healthcare. It aims to drive greater awareness and recognition of the potential of self–care to people and policymakers across the world. At GSCF, we firmly believe that everyone benefits when there is a greater choice of healthcare options and more accessible entries to care.”

Building on this year’s International Self–Care Day, GSCF is urging members and campaigners to rally behind the #SelfCareIs movement. This initiative aims to educate global audiences about the critical link between self–care and healthcare. It also encourages engagement with local policymakers and healthcare providers to call on them to put in place plans for the urgent integration of self–care into the healthcare delivery continuum.

To find out more and to get involved, please visit the campaign website: https://self–care–is–healthcare.org/.

Notes to editors

WHO definition of self–care
Self–care is the ability of individuals, families and communities to promote health, prevent disease, maintain health, and cope with illness and disability with or without the support of a health worker.

About The Global Self–Care Federation
The Global Self–Care Federation represents associations and manufacturers in the self–care industry, promoting sustainable and better global health outcomes for all. The Global Self–Care Federation is the go–to source of information for the self–care industry. We work closely with our members and relevant stakeholder groups to deliver better choice, better care and better value. By placing the benefits of self–care at the heart of what we do, promoting industry transparency, and supporting the regulated use of health data, we ensure that self–care continues to play its increasingly vital role in sustainable healthcare, worldwide. For more information please visit: www.selfcarefederation.org.

About International Self–Care Day
International Self–Care Day is held annually on July 24th (7/24), to highlight that the benefits of self–care are experienced 24 hours a day, seven days a week. International Self–Care Day raises awareness of the value of self–care and the benefit that effective self–care can bring to both individuals and healthcare systems as a vital foundation of health.

i https://www.who.int/news–room/fact–sheets/detail/self–care–health–interventions#:~:text=Self%2Dcare%20is%20the%20ability,a%20health%20or%20care%20worker.
ii https://www.selfcarefederation.org/ecosoc–report
iii https://www.nature.com/articles/s41591–024–02844–8#Sec19
iv https://www.who.int/health–topics/self–care#tab=tab_1

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b4ee215a–f0b4–4837–a280–90659dcf5aa5


GLOBENEWSWIRE (Distribution ID 1000982941)

CSL Behring Announces First Two Patients Treated with HEMGENIX® (etranacogene dezaparvovec) Gene Therapy for Hemophilia B in Europe

MARBURG, Germany, July 04, 2024 (GLOBE NEWSWIRE) — Global biotechnology leader CSL Behring (ASX: CSL) today announced that two hemophilia B patients were treated with the gene therapy HEMGENIX® (etranacogene dezaparvovec) at Hemophilia Treatment Centers in France. This milestone achievement makes HEMGENIX® the first gene therapy administered as a treatment in a real–world setting for hemophilia B in Europe.

HEMGENIX® is the first one–time gene therapy approved in Europe for the treatment of adults with severe and moderately severe hemophilia B, an inherited bleeding disorder caused by the lack of Factor IX (a protein needed to produce blood clots to stop bleeding). It is used in adults without a history of Factor IX inhibitors.1

Following European Commission approval, HEMGENIX® was the first ever therapy to be granted Direct Access in France2, thus enabling the first patients to be treated in Europe outside of the clinical program.

Though effective, current therapies can be time intensive and require regular treatment that can have a substantial impact on a patient’s daily life.3 HEMGENIX® offers a one–time treatment, allowing people living with hemophilia B to produce their own Factor IX, which can lower the risk of bleeding.4

“Only a few decades ago, gene therapy for hemophilia was a distant concept, which has now become reality. Accordingly, the first two patients treated with HEMGENIX® since receiving European approval is a major accomplishment and a testament to the joint commitment of the hemophilia B community, as well as the access and reimbursement authorities, in bringing innovative therapies to patients,” said Dr Lutz Bonacker SVP and General Manager, CSL Behring Commercial Operations Europe. “This milestone has been made possible by the innovative Direct Access scheme adopted in France, allowing patients to benefit from early access to pioneering treatments. We are encouraged to see increasing access to gene therapies in European countries and are fully committed to ensuring that access to potentially life–changing treatment continues.”

HEMGENIX® was granted conditional marketing authorisation by the European Commission (EC) for the European Union and European Economic Area in February 2023, following approval from the U.S. Food and Drug Administration (FDA) in November 2022. It has also been approved by Health Canada, the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA), Switzerland’s Swissmedic and Australia’s Therapeutic Goods Administration (TGA).

The multi–year clinical development of HEMGENIX® was led by uniQure and sponsorship of the clinical trials transitioned to CSL after it licensed global rights to commercialise the treatment.

About Hemophilia B

Hemophilia B is a life–threatening rare disease. People with the condition are particularly vulnerable to bleeds in their joints, muscles, and internal organs, leading to pain, swelling, and joint damage. Current treatments for moderate to severe hemophilia B include life–long prophylactic infusions of factor IX to temporarily replace or supplement low levels of the blood–clotting factor.  

About HEMGENIX®

HEMGENIX® is a gene therapy that reduces the rate of abnormal bleeding in eligible people with hemophilia B by enabling the body to continuously produce factor IX, the deficient protein in hemophilia B. It uses AAV5, a non–infectious viral vector, called an adeno–associated virus (AAV). The AAV5 vector carries the Padua gene variant of Factor IX (FIX–Padua) to the target cells in the liver, generating factor IX proteins that are 5x–8x more active than normal. These genetic instructions remain in the target cells, but generally do not become a part of a person’s own DNA. Once delivered, the new genetic instructions allow the cellular machinery to produce stable levels of factor IX.

About the Pivotal HOPE–B Trial

The pivotal Phase III HOPE–B trial is an ongoing, multinational, open–label, single–arm study to evaluate the safety and efficacy of HEMGENIX®. Fifty–four adult hemophilia B patients classified as having moderately severe to severe hemophilia B and requiring prophylactic factor IX replacement therapy were enrolled in a prospective, six–month or longer observational period during which time they continued to use their current standard of care therapy to establish a baseline Annual Bleeding Rate (ABR). After the six–month lead–in period, patients received a single intravenous administration of HEMGENIX® at the 2×10^13 gc/kg dose. Patients were not excluded from the trial based on pre–existing neutralizing antibodies (NAbs) to AAV5.

A total of 54 patients received a single dose of HEMGENIX® in the pivotal trial, with 52 patients completing at least three years of follow–up. The primary endpoint in the pivotal HOPE–B study was ABR 52 weeks after achievement of stable factor IX expression (months 7 to 18) compared with the six–month lead–in period. For this endpoint, ABR was measured from month seven to month 18 after infusion, ensuring the observation period represented a steady–state factor IX transgene expression. Secondary endpoints included assessment of factor IX activity.

No serious treatment–related adverse reactions were reported. One death resulting from urosepsis and cardiogenic shock in a 77–year–old patient at 65 weeks following dosing was considered unrelated to treatment by investigators and the company sponsor. A serious adverse event of hepatocellular carcinoma was determined to be unrelated to treatment with HEMGENIX® by independent molecular tumour characterization and vector integration analysis. No inhibitors to factor IX were reported. 

Long–term three–year data presented at the 17th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) 2024 continue to reinforce the potential long–lasting efficacy and safety of HEMGENIX® and the ongoing benefit of this treatment for people living with hemophilia B.

About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSL.com/Vita. For more information about CSL, visit CSL.com.

Media Contacts
Stephanie Fuchs
Mobile: +49 151 584 388 60
Email: Stephanie.Fuchs@cslbehring.com

References

1 European Medicines Agency. First Gene therapy to treat haemophilia B. Available at: https://www.ema.europa.eu/en/news/first–gene–therapy–treat–haemophilia–b. [Accessed May 2024].
2 Republique Française. Légifrance: Article 62 of Law No. 2021–1754. Available at: https://www.legifrance.gouv.fr/jorf/id/JORFTEXT000048551003 [Accessed May 2024].
3 Leebeek, F & Miesbach, W. (2021) Gene therapy for haemophilia: a review on clinical benefit, limitations, and remaining issues. Blood. Vol 138, Issue 11. pp923–931.
4 Coppens M et al. Etranacogene dezaparvovec gene therapy for haemophilia B (HOPE–B): 24–month post–hoc efficacy and safety data from a single–arm, multicentre, phase 3 trial. The Lancet Haematology 2024; 11(4):E265–E275.


GLOBENEWSWIRE (Distribution ID 1000969961)

Fortrea lance un studio d’innovation en IA pour galvaniser les solutions technologiques et humaines afin d’améliorer la réalisation des essais cliniques

DURHAM, État de Caroline du Nord, 28 juin 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq : FTRE), un organisme de recherche sous contrat (« ORC ») de premier plan au niveau mondial, a annoncé aujourd’hui le lancement de son studio d’innovation en intelligence artificielle (« IA »), marquant ainsi un investissement stratégique visant à remodeler l’exécution des essais cliniques aujourd’hui et à l’avenir.

Le studio développera et déploiera des technologies d’IA et d’apprentissage automatique visant à favoriser la rapidité, l’agilité, la qualité et le renforcement de la sécurité des patients dans le processus de recherche clinique en équipant et en habilitant les personnes à se concentrer sur l’élément humain critique des essais cliniques.

« Partout dans le monde, des patients attendent des traitements novateurs qui changeront leur vie. Grâce à l’IA, nous avons désormais le pouvoir — et l’obligation — de les aider à trouver des solutions plus rapidement », a déclaré Alejandro Martinez Galindo, directeur des systèmes d’information de Fortrea, avant d’ajouter :

« Le studio d’innovation en IA de Fortrea offrira des capacités technologiques améliorées qui permettront aux systèmes dotés d’IA d’exécuter des processus de pointe, tels que des simulations d’essai, des analyses prédictives et la reconnaissance de motifs, ainsi que des tâches administratives répétitives, « adaptées aux machines ». Cela permet de libérer la disponibilité des personnes pour qu’elles puissent apporter leur créativité humaine et leur connexion à l’essai clinique de demain et se concentrer sur ce qui compte : le patient. »

Le studio d’innovation en IA de Fortrea vise à :

  • établir des partenariats au sein de Fortrea et avec nos clients afin de fournir des solutions technologiques pour des stratégies d’innovation sur mesure pour les centres et les promoteurs ;
  • développer de nouvelles innovations technologiques nettes qui améliorent de manière globale la réalisation des essais cliniques pour les promoteurs, les centres, les patients et nos équipes ; et
  • soutenir l’infrastructure et les opérations existantes avec une technologie améliorée afin de permettre de nouvelles et meilleures méthodes de travail et créer les meilleures expériences pour les utilisateurs.

Les technologies en cours de développement dans le studio comprennent la collecte de données à l’aide de smartphones, des modèles linguistiques spécialisés à grande échelle pour la compréhension et la génération de textes, l’IA symbolique avec une logique à valeurs réelles (c.–à–d. la construction d’une logique de décision à l’aide de scénarios et de données en situation réelle), la réalité mixte et l’intelligence augmentée, l’exploration de données avancées et l’analyse prédictive, ainsi que le jumelage numérique.

L’application stratégique de ces technologies devrait permettre des avancées significatives en matière de recrutement et de fidélisation des patients, de création et d’optimisation des protocoles, de contrôle de la qualité en fonction des risques, ainsi que de rapidité et de qualité globales des prestations. Ces technologies peuvent également améliorer l’expérience des patients et la productivité des clients, des centres et des employés de Fortrea.

Les développements du studio d’innovation en IA seront essentiels pour la plateforme technologique clinique de Fortrea, qui est conçue pour intégrer la technologie des essais cliniques dans une expérience utilisateur, indépendante de la localisation, omnicanale et basée sur les personas, accessible à partir d’un seul écran.

« Fortrea se concentre sur une vision future du secteur des ORC, ce qui nous permet de construire POUR l’avenir plutôt que POUR le passé », a déclaré Brian Dolan, vice–président du Département d’intelligence artificielle et d’apprentissage automatique, avant d’ajouter : « Nous accordons une grande attention au développement et au déploiement responsables et éthiques de l’IA, en privilégiant les bonnes actions pour les bonnes raisons et en protégeant la sécurité et la vie privée des patients, ainsi que la propriété intellectuelle de nos clients. »

À propos de Fortrea
Fortrea (Nasdaq : FTRE) est l’un des principaux fournisseurs mondiaux de solutions de développement clinique dans le secteur des sciences de la vie. Nous nous associons à des entreprises émergentes et établies du secteur biopharmaceutique, de la biotechnologie, des dispositifs médicaux et du diagnostic pour stimuler l’innovation dans le domaine de la santé et accélérer la mise à disposition de traitements révolutionnaires pour les patients. Fortrea propose des services de gestion d’essais cliniques de phase I à IV, de pharmacologie clinique et de consulting. Nos solutions s’appuient sur 30 ans d’expérience dans 20 domaines thérapeutiques, une passion pour la rigueur scientifique, des connaissances exceptionnelles et un solide réseau de centres de recherche. Notre équipe talentueuse et diversifiée répartie dans plus de 90 pays est dimensionnée pour fournir des solutions ciblées et agiles à nos clients, partout dans le monde. Pour en savoir plus sur la manière dont Fortrea est un moteur d’influence du pipeline au patient, rendez–vous sur Fortrea.com et suivez–nous sur LinkedIn et X (anciennement Twitter).

Coordonnées de Fortrea :
Hima Inguva (Investisseurs) – 877–495–0816, hima.inguva@fortrea.com
Jennifer Minx (Médias) – 919–410–4195, media@fortrea.com
Kate Dillon (Médias) – 646–818–9115, kdillon@prosek.com


GLOBENEWSWIRE (Distribution ID 9170901)

Fortrea startet KI-Innovationsstudio, um Technologie und menschliche Lösungen zur Verbesserung der Durchführung klinischer Studien zu bündeln

DURHAM, N.C., June 28, 2024 (GLOBE NEWSWIRE) — Fortrea (Nasdaq: FTRE), ein führendes globales Auftragsforschungsinstitut (CRO), gab heute die Einführung seines Innovationsstudios für künstliche Intelligenz (KI) bekannt und signalisiert damit eine strategische Investition in die Neugestaltung der Durchführung von klinischen Studien heute und in Zukunft.

Das Studio wird KI–Technologien und Technologien für maschinelles Lernen (ML) entwickeln und einsetzen, um den klinischen Forschungsprozess zu beschleunigen, flexibler zu gestalten, die Qualität zu verbessern und die Patientensicherheit zu erhöhen, indem es die Mitarbeitenden in die Lage versetzt, sich auf das kritische menschliche Element der klinischen Studien zu konzentrieren.

„Weltweit warten Patienten auf neue, lebensverändernde Behandlungen. Mit KI haben wir jetzt die Möglichkeit – und die Verpflichtung – ihnen schneller Lösungen zu liefern“, sagte Alejandro Martinez Galindo, Chief Information Officer von Fortrea.

„Das KI–Innovationstudio von Fortrea wird erweiterte technologische Fähigkeiten ermöglichen, die KI–fähigen Systemen erlauben, innovative Prozesse wie Versuchssimulationen, prädiktive Analysen und Mustererkennung sowie sich wiederholende, administrative, 'maschinenfreundliche Aufgaben' durchzuführen. Das gibt Menschen die Freiheit, ihre menschliche Kreativität und Verbundenheit in die klinische Studie von morgen einzubringen und sich auf das zu konzentrieren, was zählt: den Patienten.“

Das KI–Innovationsstudio von Fortrea zielt auf Folgendes ab:

  • Partnerschaft mit Fortrea und unseren Kunden, um Technologielösungen für maßgeschneiderte Innovationsstrategien für Standorte und Sponsoren zu entwickeln;
  • Entwicklung neuer technologischer Innovationen, die die Durchführung von klinischen Studien für Sponsoren, Standorte, Patienten und unsere Teams ganzheitlich verbessern; und
  • Unterstützung bestehender Infrastruktur und Abläufe durch verbesserte Technologie, um neue, verbesserte Arbeitsweisen zu ermöglichen und erstklassige Benutzererfahrungen zu schaffen.

Zu den Technologien, die im Studio entwickelt werden, gehören Smartphone–gestützte Datenerfassung, spezialisierte große Sprachmodelle für Textverständnis und –generierung, symbolische KI mit realwertiger Logik (d.h. Aufbau von Entscheidungslogik unter Verwendung von Szenarien und Daten aus der realen Welt), gemischte Realität und erweiterte Intelligenz, fortgeschrittenes Data Mining und prädiktive Analysen sowie digitale Zwillinge.

Es wird erwartet, dass die strategische Anwendung dieser Technologien zu bedeutenden Fortschritten bei der Rekrutierung und Bindung von Patienten, der Erstellung/Optimierung von Protokollen, der risikobasierten Qualitätsüberwachung sowie der allgemeinen Bereitstellungsgeschwindigkeit und –qualität führen wird. Diese Technologien können auch zu einem verbesserten Patientenerlebnis und einer höheren Produktivität für Kunden, Standorte und Mitarbeitende von Fortrea führen.

Die Entwicklungen des KI–Innovationsstudios werden für die klinische Technologieplattform von Fortrea von entscheidender Bedeutung sein. Sie soll die Technologie für klinische Studien in eine verbrauchergerechte, ortsunabhängige, kanalübergreifende und personenbezogene Erfahrung integrieren, die über einen einzigen Bildschirm zugänglich ist.

„Fortrea konzentriert sich auf eine Zukunftsvision der CRO–Branche, die uns ermöglicht, FÜR die Zukunft zu bauen und nicht VON der Vergangenheit aus“, sagte Brian Dolan, Vice President of Artificial Intelligence & Machine Learning. „Wir legen großen Wert auf die verantwortungsvolle und ethische Entwicklung und den Einsatz von KI. Dabei ist es uns wichtig, das Richtige aus den richtigen Gründen zu tun und die Sicherheit der Patienten und den Schutz ihrer Daten sowie das geistige Eigentum unserer Kunden zu schützen.“

Über Fortrea
Fortrea (Nasdaq: FTRE) ist ein weltweit führender Anbieter von Lösungen für die klinische Entwicklung in der Biowissenschaftsbranche. Wir arbeiten mit aufstrebenden und großen biopharmazeutischen, biotechnologischen, medizintechnischen und diagnostischen Unternehmen zusammen, um Innovationen im Gesundheitswesen voranzutreiben, die das Angebot lebensverändernder Therapien für Patienten beschleunigen. Fortrea bietet Management von klinischen Studien der Phasen I–IV, klinische Pharmakologie und Beratungsdienste an. Die Lösungen von Fortrea basieren auf drei Jahrzehnten Erfahrung in mehr als 20 Therapiegebieten, einer Leidenschaft für wissenschaftliche Strenge, außergewöhnlichen Erkenntnissen und einem starken Netzwerk von Prüfzentren. Unser talentiertes und vielseitiges Team in über 90 Ländern ist so skaliert, dass wir unseren Kunden weltweit gezielte und flexible Lösungen anbieten können. Mehr darüber, wie Fortrea zu einer transformativen Kraft von der Pipeline bis zum Patienten wird, erfahren Sie auf Fortrea.com und wenn Sie uns auf LinkedIn und X (früherTwitter) folgen.

Kontakt zu Fortrea:
Hima Inguva (Investoren) – 877–495–0816, hima.inguva@fortrea.com
Jennifer Minx (Medien) – 919–410–4195, media@fortrea.com
Kate Dillon (Medien) – 646–818–9115, kdillon@prosek.com


GLOBENEWSWIRE (Distribution ID 9170901)