SARA-INT PHASE 2B INTERVENTIONAL CLINICAL TRIAL
We have currently tested the safety and efficacy of BIO101 (20-hydroxyecdysone) in a global, randomized, multicenter, double-blind, placebo-controlled Phase 2 clinical trial in sarcopenia (SARA-INT).
The last patient out was in December 2020. From the 233 initially enrolled in the 22 centers in the US and Belgium, 196 participants with sarcopenia at risk of mobility disability completed the study.
Top line results of SARA-INT Phase 2 study with BIO101 (20-hydroxyecdysone) in Sarcopenia have been announced on August 02, 2021.
- BIO101 (20-hydroxyecdysone) at the highest dose (350 mg bid) showed a clinically meaningful improvement in the 400-meter walk test (400MWT), the primary endpoint of the study
- BIO101 (20-hydroxyecdysone) showed a very good safety profile at the doses of 175 mg bid and of 350 mg bid with no Serious Adverse Events (AE) related to the product.
BIO101 (20-hydroxyecdysone) now has the potential to be the first drug candidate to enter Phase 3 in sarcopenia. Biophytis has received approval to initiate the SARA-31 study in Belgium and the United States in the second half of 2023. Approvals may be sought in other countries, depending on the needs of the study. The effective start of the study is planned for 2024 and will depend on the conclusion of partnership agreements and the Company’s financial resources.
The primary endpoint of this Phase 3 trial as presented to the agencies is the ability to complete the 400m walk test in less than 15 minutes. This primary endpoint will be supplemented by the following secondary endpoints: Gait speed 4-m from SPPB, grip strength (HGS) and Patient Reported Outcome (PRO).