Biophytis obtains EMA authorization to launch its Phase 2 clinical trial in obesity

Biophytis announces that the European Medicines Agency (EMA) has issued a favorable outcome on Part I of its Clinical Trial Application (CTA) for the initiation of a Phase 2 clinical trial of BIO101 (20-hydroxyecdysone) in patients suffering from muscle wasting associated with obesity (OBA study).

This milestone represents a crucial regulatory step in advancing Biophytis’ clinical development strategy within Europe. The favorable review of the scientific dossier (Part I) confirms the quality, safety, and preclinical/clinical data package supporting the initiation of the trial. Pending completion of Part II reviews at the national level by Ethics Committees, Biophytis expects to initiate patient recruitment in the coming months in Europe.

Stanislas Veillet, Chief Executive Officer of Biophytis, commented:

“We are very pleased with the EMA’s positive outcome on our CTA submission, which marks an important regulatory validation of our program. Muscle wasting in patients with obesity is an underrecognized but serious condition that substantially contributes to long-term disability and healthcare burden. Advancing BIO101 into Phase 2 clinical testing in Europe is a major step toward addressing this critical unmet medical need.”

Next Development

With Part I approval secured, Biophytis will now proceed with Part II submissions to national Competent Authorities and Ethics Committees in Europe. In parallel, Biophytis is actively pursuing its global regulatory strategy for BIO101. Following prior interactions with ANVISA, the Brazilian Health Regulatory Agency, the Company is preparing a registration dossier to support the initiation of the trial in Brazil.