Biophytis Confirms the Launch of the Phase 2 OBA Clinical Trial in Obesity
Biophytis has confirmed the launch of its Phase 2 OBA clinical trial for obesity treatment, set to commence in 2025. The study will evaluate BIO101's efficacy and safety in reducing muscle strength loss caused by GLP-1 agonists in obesity patients.
Following a recent €2.6 million capital increase and promising preclinical results presented at the 15th International Conference on Frailty and Sarcopenia, the company is advancing BIO101's clinical development. The program received FDA IND clearance in July 2024, with expertise from obesity specialist Professor Marc-André Cornier.
The company's current priority is securing a pharmaceutical partner to co-develop BIO101 in obesity, supporting clinical and regulatory development through marketing authorization and product launch in North America.
Biophytis ha confermato il lancio del suo trial clinico di Fase 2 OBA per il trattamento dell'obesità, che inizierà nel 2025. Lo studio valuterà l'efficacia e la sicurezza di BIO101 nella riduzione della perdita di forza muscolare causata dagli agonisti del GLP-1 nei pazienti obesi.
Dopo un recente aumento di capitale di 2,6 milioni di euro e risultati preclinici promettenti presentati alla 15ª Conferenza Internazionale sulla Fragilità e Sarcopenia, l'azienda sta portando avanti lo sviluppo clinico di BIO101. Il programma ha ricevuto l'approvazione IND dalla FDA nel luglio 2024, con la consulenza dello specialista in obesità Professor Marc-André Cornier.
La priorità attuale dell'azienda è quella di assicurarsi un partner farmaceutico per co-sviluppare BIO101 nell'obesità, supportando lo sviluppo clinico e normativo fino all'autorizzazione al commercio e al lancio del prodotto in Nord America.
Biophytis ha confirmado el lanzamiento de su ensayo clínico de Fase 2 OBA para el tratamiento de la obesidad, que comenzará en 2025. El estudio evaluará la eficacia y seguridad de BIO101 en la reducción de la pérdida de fuerza muscular causada por agonistas de GLP-1 en pacientes obesos.
Tras un reciente aumento de capital de 2,6 millones de euros y resultados preclínicos prometedores presentados en la 15ª Conferencia Internacional sobre Fragilidad y Sarcopenia, la empresa está avanzando en el desarrollo clínico de BIO101. El programa recibió la aprobación IND de la FDA en julio de 2024, con la experiencia del especialista en obesidad, el Profesor Marc-André Cornier.
La prioridad actual de la empresa es asegurar un socio farmacéutico para co-desarrollar BIO101 en obesidad, apoyando el desarrollo clínico y regulatorio hasta la autorización de comercialización y el lanzamiento del producto en América del Norte.
Biophytis는 2025년에 시작될 2상 OBA 임상 시험의 시작을 확인했습니다. 이 연구는 비만 환자에서 GLP-1 작용제에 의해 유발되는 근육 강도 감소를 줄이는 데 있어 BIO101의 효능과 안전성을 평가할 것입니다.
최근 260만 유로의 자본 증가와 15회 국제 노쇠 및 근감소증 회의에서 발표된 유망한 전임상 결과에 이어, 회사는 BIO101의 임상 개발을 진행하고 있습니다. 이 프로그램은 2024년 7월 FDA IND 승인을 받았으며, 비만 전문의인 Marc-André Cornier 교수의 전문 지식을 활용하고 있습니다.
회사의 현재 우선 사항은 BIO101을 비만 치료를 위해 공동 개발할 제약 파트너를 확보하는 것이며, 북미에서의 마케팅 승인 및 제품 출시를 통해 임상 및 규제 개발을 지원하고 있습니다.
Biophytis a confirmé le lancement de son essai clinique de Phase 2 OBA pour le traitement de l'obésité, qui débutera en 2025. L'étude évaluera l'efficacité et la sécurité de BIO101 dans la réduction de la perte de force musculaire causée par les agonistes du GLP-1 chez les patients obèses.
Suite à une récente augmentation de capital de 2,6 millions d'euros et des résultats précliniques prometteurs présentés lors de la 15e Conférence Internationale sur la Fragilité et la Sarcopénie, l'entreprise fait avancer le développement clinique de BIO101. Le programme a reçu l'approbation IND de la FDA en juillet 2024, avec l'expertise du spécialiste de l'obésité, le Professeur Marc-André Cornier.
La priorité actuelle de l'entreprise est de sécuriser un partenaire pharmaceutique pour co-développer BIO101 dans le domaine de l'obésité, soutenant le développement clinique et réglementaire jusqu'à l'autorisation de mise sur le marché et le lancement du produit en Amérique du Nord.
Biophytis hat den Start seiner Phase 2 OBA-Studie zur Behandlung von Adipositas bestätigt, die 2025 beginnen soll. Die Studie wird die Wirksamkeit und Sicherheit von BIO101 bei der Verringerung des durch GLP-1-Agonisten verursachten Muskelkraftverlusts bei adipösen Patienten bewerten.
Nach einer kürzlichen Kapitalerhöhung von 2,6 Millionen Euro und vielversprechenden präklinischen Ergebnissen, die auf der 15. Internationalen Konferenz über Gebrechlichkeit und Sarkopenie vorgestellt wurden, treibt das Unternehmen die klinische Entwicklung von BIO101 voran. Das Programm erhielt im Juli 2024 die FDA IND-Zulassung, mit Expertise des Adipositas-Spezialisten Professor Marc-André Cornier.
Die aktuelle Priorität des Unternehmens besteht darin, einen Pharmapartner zu gewinnen, um BIO101 in der Adipositas zu entwickeln und die klinische sowie regulatorische Entwicklung bis zur Marktzulassung und Produkteinführung in Nordamerika zu unterstützen.
- Secured FDA IND clearance for OBA program
- Successfully raised €2.6 million in capital
- Reported promising preclinical results
- Collaboration with renowned obesity expert Prof. Marc-André Cornier
- Requires pharmaceutical partner for further development
- Clinical trial yet to begin despite IND clearance in 2024
Paris, France and Cambridge, Massachusetts--(Newsfile Corp. - April 9, 2025) - Biophytis SA (FP: ALBPS), ("Biophytis" or the "Company"), a clinical-stage biotechnology company specializing in the development of treatments for age-related diseases, confirms the launch of the Phase 2 OBA clinical study in obesity, expected to begin as early as possible in 2025.
Following the recent €2.6 million capital increase announced on March 26, 2025, and promising preclinical results presented at the 15th International Conference on Frailty and Sarcopenia in Toulouse, Biophytis will continue the clinical development of BIO101 in obesity. The goal is to evaluate the efficacy and safety of BIO101 in reducing muscle strength loss caused by GLP-1 agonists in patients with obesity.
As a reminder, Biophytis received Investigational New Drug (IND) clearance from the FDA in July 2024, marking a major milestone for the OBA program, which benefits from the expertise of Professor Marc-André Cornier, a world-renowned expert in the field of obesity.
Stanislas Veillet, CEO of Biophytis, stated: "The company's priority is now to find a pharmaceutical partner to co-develop BIO101 in obesity. This partner will support us in the clinical and regulatory development of our drug candidate through to marketing authorization and will lead the product launch in North America."
About BIOPHYTIS
Biophytis SA is a clinical-stage biotechnology company focused on developing drug candidates for age- related diseases. BIO101 (20-hydroxyecdysone), our lead drug candidate, is a small molecule in development for muscular diseases (sarcopenia, Phase 3 ready to start, and Duchenne muscular dystrophy, Phase 1-2 to be started), respiratory diseases (COVID-19, Phase 2-3 completed), and metabolic disorders (obesity, Phase 2 to be started). The company is headquartered in Paris, France, with subsidiaries in Cambridge, Massachusetts, USA, and Brazil. The Company's ordinary shares are listed on Euronext Growth Paris (ALBPS - FR001400OLP5) and its ADS (American Depositary Shares) are listed on the OTC market (BPTSY - US 09076G401). For more information, visit www.biophytis.com.
Disclaimer
This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as "outlook," "believes," "expects," "potential," "continues," "may," "will," "should," "could," "seeks," "predicts," "intends," "trends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. Such forward-looking statements are based on assumptions that Biophytis considers to be reasonable. However, there can be no assurance that the statements contained in such forward-looking statements will be verified, which are subject to various risks and uncertainties. The forward- looking statements contained in this press release are also subject to risks not yet known to Biophytis or not currently considered material by Biophytis. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. Please also refer to the "Risk and uncertainties the Company is to face" section from the Company's 2023 Financial Report available on BIOPHYTIS website (www.biophytis.com) and as exposed in the "Risk Factors" section of form 20-F as well as other forms filed with the SEC (Securities and Exchange Commission, USA). We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.
Contact Biophytis:
Business Development and Partnerships
Edouard.bieth@biophytis.com
Investor Relations
Investors@biophytis.com
US Investors
Pascal Nigen - Alpha Bronze
pnigen@alphabronzellc.com
Media Contacts
Antoine Denry: antoine.denry@taddeo.fr -- +33 6 18 07 83 27
Inès de Mandiargues: ines.demandiargues@taddeo.fr --+33 6 16 16 51 78
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/247801
FAQ
What is the purpose of Biophytis' Phase 2 OBA clinical trial for BIO101?
When did Biophytis receive FDA IND clearance for the OBA program?
How much capital did Biophytis raise in March 2025?
What are Biophytis' current partnership plans for BIO101 development?
