Clinical-stage biotechnology company Biophytis SA (Euronext Growth Paris:ALBPS) (OTC:BPTSY), a developer of therapies targeting obesity, sarcopenia, and longevity, announced on Wednesday that the European Medicines Agency has approved Part I of its Clinical Trial Application for BIO101 (20-hydroxyecdysone).

The Phase 2 OBA study will evaluate the drug in patients with muscle wasting linked to obesity.

The EMA's favourable review validates the quality, safety, and preclinical and clinical data supporting trial initiation.

Biophytis expects to begin patient recruitment in Europe once Part II national-level reviews by Ethics Committees are completed.

The company will now move forward with Part II submissions across European markets. At the same time, Biophytis is advancing its global regulatory strategy, preparing a registration dossier for Brazil following prior interactions with national health authority ANVISA.