Biophytis Reports the US FDA’s IND Clearance to Initiate the P-II Trial of BIO101 for Treating Obesity
Shots:
- The US FDA has approved Biophytis’ IND application to initiate the P-II OBA trial of BIO101 (20-hydroxyecdysone) for the treatment of obesity
- The 1EP of the trial includes muscle strength improvement evaluated using knee extension test while 2EPs include mobility analysis (through 6-minute walk test) and body composition (fat and lean mass evaluation)
- The study is anticipated in mid-2024 across the US with its extension across the EU; preliminary efficacy data are planned in 2025. The company is currently looking for collaborations and fundings for the trial
Ref: Biophytis | Image: Biophytis
Related News:- Biophytis and Blanver Collaborate to Develop BIO101 for Treating Multiple Indications
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
