SARA-INT-STUDY (Finished)
Brief summary:
SARA-INT PHASE 2B INTERVENTIONAL CLINICAL TRIAL
We have currently tested the safety and efficacy of Sarconeos (BIO101) 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 Sarconeos (BIO101) in Sarcopenia have been announced on August 02, 2021.
Sarconeos (BIO101) 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.
Sarconeos (BIO101) 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.
Sponsor: Biophytis
Principal Investigator: prof. Ivan Bautmans
Tauriel study (Finished)
Brief summary
This was a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label Semorinemab treatment.
Sponsor: Genentech
Principal Investigator: prof. Dr. Siddhartha Lieten