Biophytis Secures Approval for OBA Clinical Trial in Brazil

Biotechnology company Biophytis announced its approval from Brazil's ANVISA to initiate the Phase 2 OBA clinical trial for obesity. This milestone follows previous approvals in the US and Europe and strengthens Biophytis' capacity for multi-regional clinical development. The trial focuses on the drug candidate BIO101, targeting both obesity and sarcopenia.

Biophytis' strategy in Brazil is supported by a partnership with pharmaceutical company Blanver. The approval enables Biophytis to implement the trial in a region facing high obesity rates and significant medical needs. The combination of BIO101 with GLP-1 therapies aims to preserve muscle strength and restore mobility in obese patients.

The company plans to finalize a contract with Blanver and EMBRAPII for the trial's co-financing. Additionally, a study on BIO101's effects during the rebound weight gain phase will be integrated, targeting a critical unmet medical need. The trial aims to commence in early 2027.