Monday, Biophytis SA BPTS announced the launch of a new clinical development program named OBA, with BIO101 (20-hydroxyecdysone) as a potential treatment for obesity combined with GLP-1 receptor agonists.
The OBA Phase 2 clinical study is expected to start in mid-2024, upon regulatory approvals, with the first patients expected to be treated in the second half of 2024.
BIO101 (20-hydroxyecdysone) will be evaluated in obese patients treated with GLP-1 RAs and following hypocaloric dieting.
With accelerated clinical development, the first efficacy results are expected in 2025.
The company says BIO101 (20-hydroxyecdysone) is the first oral daily MAS receptor activator and has demonstrated metabolic effects on muscle and fat tissues in preclinical obesity studies.
These beneficial effects of BIO101 (20-hydroxyecdysone) may translate into improved mobility and muscle strength in obese sarcopenic patients, as suggested in the SARA-INT phase 2 study.
Furthermore, the 20-hydroxyecdysone molecule was already tested in obese patients during hypocaloric dieting in the Quinolia study, showing promising effects on muscle strength and fat mass loss.
In its 2023 earnings release, the company shared the final results of the Phase 2/3 COVA trial.
The study met its primary objective, with a 44% (p=0.043) reduction in the risk of respiratory failure or early death in patients hospitalized with severe COVID-19.
In addition, BIO101 (20-hydroxyecdysone) showed an encouraging safety profile, with a lower proportion of patients experiencing adverse events than placebo (57% vs. 64%).
The company is implementing regulatory procedures to assess market access conditions based on the COVA study results and preparation for the design of a second confirmatory phase 3 trial.
Biophytis is also establishing industrial partnerships with the Seqens and Skyepharma groups to produce the BIO101 (20-hydroxyecdysone) drug candidate commercially.
Price Action: BPTS shares are up 22.30% at $0.39 on the last check Tuesday.
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