Biophytis Revolutionizes Sarcopenia
Biophytis (FP: ALBPS) has announced the publication of its Phase 2 clinical trial SARA-INT results for BIO101 in the Journal of Cachexia, Sarcopenia and Muscle. The trial demonstrated promising efficacy for treating sarcopenia, showing clinically meaningful improvement in the 400-meter walk test at 350mg bid dosing.
Key findings include:
- Excellent safety profile with no serious adverse events
- Significant treatment effects versus placebo in slow walkers and sarcopenic obesity subpopulations
- Progress in obtaining Phase 3 trial regulatory approvals
The company is advancing discussions with a major pharmaceutical company in China and other Asian partners. Notably, sarcopenia affects 121-194 million people globally, with no current therapeutic solutions available. Biophytis positions itself as the most advanced company developing treatment for this age-related condition.
Biophytis (FP: ALBPS) ha annunciato la pubblicazione dei risultati del suo studio clinico di Fase 2 SARA-INT per BIO101 nella rivista Journal of Cachexia, Sarcopenia and Muscle. Lo studio ha dimostrato un'efficacia promettente nel trattamento della sarcopenia, mostrando un miglioramento clinicamente significativo nel test di cammino di 400 metri con dosaggio di 350 mg due volte al giorno.
I principali risultati includono:
- Ottimo profilo di sicurezza senza eventi avversi gravi
- Effetti significativi del trattamento rispetto al placebo in popolazioni con camminatori lenti e obesità sarcopenica
- Progressi nell'ottenere le approvazioni regolatorie per lo studio di Fase 3
L'azienda sta portando avanti discussioni con una grande compagnia farmaceutica in Cina e altri partner asiatici. È importante notare che la sarcopenia colpisce tra 121 e 194 milioni di persone a livello globale, senza soluzioni terapeutiche attualmente disponibili. Biophytis si posiziona come l'azienda più avanzata nello sviluppo di trattamenti per questa condizione legata all'età.
Biophytis (FP: ALBPS) ha anunciado la publicación de los resultados de su ensayo clínico de Fase 2 SARA-INT para BIO101 en la revista Journal of Cachexia, Sarcopenia and Muscle. El ensayo demostró una eficacia prometedora para el tratamiento de la sarcopenia, mostrando una mejora clínicamente significativa en la prueba de caminata de 400 metros con una dosis de 350 mg dos veces al día.
Los hallazgos clave incluyen:
- Excelente perfil de seguridad sin eventos adversos graves
- Efectos significativos del tratamiento frente al placebo en subpoblaciones de caminadores lentos y obesidad sarcopénica
- Progresos en la obtención de aprobaciones regulatorias para el ensayo de Fase 3
La empresa está avanzando en discusiones con una importante compañía farmacéutica en China y otros socios asiáticos. Cabe destacar que la sarcopenia afecta a entre 121 y 194 millones de personas en todo el mundo, sin soluciones terapéuticas disponibles en la actualidad. Biophytis se posiciona como la empresa más avanzada en el desarrollo de tratamientos para esta condición relacionada con la edad.
Biophytis (FP: ALBPS)는 SARA-INT의 BIO101에 대한 2상 임상 시험 결과를 Journal of Cachexia, Sarcopenia and Muscle에 발표했다고 발표했습니다. 이 시험은 사르코페니아 치료에 대한 유망한 효능을 입증했으며, 350mg의 복용량으로 400미터 걷기 테스트에서 임상적으로 의미 있는 개선을 보여주었습니다.
주요 결과는 다음과 같습니다:
- 심각한 부작용이 없는 우수한 안전성 프로필
- 느린 보행자 및 사르코펜 비만 하위 집단에서 위약 대비 유의미한 치료 효과
- 3상 시험 규제 승인 확보의 진전
회사는 중국의 주요 제약회사 및 기타 아시아 파트너와의 논의를 진행하고 있습니다. 특히, 사르코페니아는 전 세계적으로 1억 2천만에서 1억 9천4백만 명에게 영향을 미치며 현재 치료 솔루션이 없습니다. Biophytis는 이 노화 관련 질환에 대한 치료를 개발하는 가장 진보된 회사로 자리매김하고 있습니다.
Biophytis (FP : ALBPS) a annoncé la publication des résultats de son essai clinique de Phase 2 SARA-INT pour BIO101 dans le Journal of Cachexia, Sarcopenia and Muscle. L'essai a démontré une efficacité prometteuse pour le traitement de la sarcopénie, montrant une amélioration cliniquement significative dans le test de marche de 400 mètres avec une posologie de 350 mg deux fois par jour.
Les principales conclusions incluent :
- Excellent profil de sécurité sans événements indésirables graves
- Effets significatifs du traitement par rapport au placebo chez les marcheurs lents et les sous-populations d'obésité sarcopénique
- Progrès dans l'obtention des approbations réglementaires pour l'essai de Phase 3
L'entreprise poursuit des discussions avec une grande société pharmaceutique en Chine et d'autres partenaires asiatiques. Il est à noter que la sarcopénie touche entre 121 et 194 millions de personnes dans le monde, sans solutions thérapeutiques disponibles actuellement. Biophytis se positionne comme l'entreprise la plus avancée dans le développement d'un traitement pour cette condition liée à l'âge.
Biophytis (FP: ALBPS) hat die Veröffentlichung der Ergebnisse seiner Phase-2-Studie SARA-INT für BIO101 im Journal of Cachexia, Sarcopenia and Muscle bekannt gegeben. Die Studie zeigte vielversprechende Wirksamkeit bei der Behandlung von Sarkopenie und zeigte eine klinisch bedeutsame Verbesserung im 400-Meter-Gehtest bei einer Dosierung von 350 mg zweimal täglich.
Wichtige Ergebnisse umfassen:
- Ausgezeichnetes Sicherheitsprofil ohne schwerwiegende unerwünschte Ereignisse
- Signifikante Behandlungseffekte gegenüber Placebo bei langsamen Gehern und sarcopenischer Adipositas
- Fortschritte bei der Erlangung von Genehmigungen für Phase-3-Studien
Das Unternehmen führt Gespräche mit einem großen Pharmaunternehmen in China und anderen asiatischen Partnern. Bemerkenswerterweise betrifft Sarkopenie weltweit 121 bis 194 Millionen Menschen, ohne dass derzeit therapeutische Lösungen verfügbar sind. Biophytis positioniert sich als das am weitesten fortgeschrittene Unternehmen, das eine Behandlung für diese altersbedingte Erkrankung entwickelt.
- Successful Phase 2 trial results with clinically meaningful improvement in primary endpoint
- Excellent safety profile with no serious adverse events
- Publication in prestigious Journal of Cachexia, Sarcopenia and Muscle
- Large market potential with 121-194 million affected patients globally
- First-mover advantage in sarcopenia treatment development
- Advanced discussions with major pharmaceutical partners in Asia
- Product still requires Phase 3 trial completion and regulatory approval
- Partnership discussions still ongoing without confirmed agreements
Publication of SARA-INT Phase II results for BIO101
Confirmation of Phase 3 readiness
Paris, France and Cambridge, Massachusetts--(Newsfile Corp. - March 17, 2025) - Biophytis SA (FP: ALBPS) ("Biophytis" or the "company"), a clinical-stage biotechnology company specialized in developing therapies for age-related diseases, is excited to announce a world premiere: the publication of the Phase 2 clinical trial SARA-INT in the Journal of Cachexia, Sarcopenia and Muscle (JCSM), the key reference journal for research on sarcopenia.
Key BIO101 Attributes from the SARA INT Trail include:
Promising Efficacy: BIO101 350mg bid demonstrates a clinically meaningful improvement in the 400-meter walk test (400MWT), primary endpoint of the study
Excellent Safety: At all doses, BIO101 shows a very good safety profile with no Serious Adverse Events (AE) related to the product
Greater Efficacy in high-risk population: Nominally significant treatment effect versus placebo in the 400MWT gait speed in slow walkers and sarcopenic obesity subpopulations
Complete publication can be found here
Biophytis has made significant progress in obtaining regulatory approvals for its Phase 3 trial in sarcopenia and is accelerating discussions with a major international pharmaceutical company in China as well as other industrial partners in Asia.
Key features to remind:
Sarcopenia affects between 121 and 194 million people worldwide, a trend that will further accelerate in the coming years and decades with the aging of the population
No therapeutic solution exists today for treating sarcopenia
Biophytis is the most advanced company in this indication with BIO101
***
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
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/244757
FAQ
What were the key results of Biophytis' SARA-INT Phase 2 trial for BIO101?
How many people are affected by sarcopenia globally?
What are Biophytis' next steps for BIO101 development?
Are there any current therapeutic treatments available for sarcopenia?
