Biophytis Receives EMA and Belgian Regulatory Approval for Phase 3 Sarcopenia Trial

Key Insights

• Biophytis SA has received both EMA Part I scientific approval and Belgian Part II ethical approval to initiate a Phase 3 clinical trial for sarcopenia treatment.
• The regulatory clearances allow patient enrollment to begin in Belgium with plans for collaboration across additional European Member States under the harmonized framework.
• The trial will evaluate BIO101 (20-hydroxyecdysone), the company's lead small molecule drug candidate, marking a significant milestone in developing therapies for age-related muscle loss.

Biophytis SA, a clinical-stage biotechnology company focused on age-related diseases, has received regulatory approval from both the European Medicines Agency (EMA) and Belgian authorities to initiate a Phase 3 clinical trial for sarcopenia. The dual approvals encompass both scientific validity and ethical considerations, enabling the company to begin patient enrollment in Belgium and collaborate with leading clinical centers across additional European Member States.

Regulatory Milestone Achievement

The EMA completed its comprehensive Part I evaluation, confirming that the Phase 3 sarcopenia trial meets all requirements for clinical and scientific rigor. The assessment included a detailed review of the study protocol, benefit-risk profile, product quality, and supporting documentation, affirming the scientific validity and safety of the proposed research.

Concurrently, Belgian authorities concluded their Part II review, approving all national and ethical aspects of the study. This approval encompasses local considerations including informed consent procedures, data protection, investigator qualifications, and safeguards for participant wellbeing, ensuring the trial will be conducted in compliance with Belgian regulations and to the highest ethical standards.

BIO101 Drug Candidate

The Phase 3 trial will evaluate BIO101 (20-hydroxyecdysone), Biophytis' lead drug candidate. BIO101 is a small molecule currently in development for muscular diseases, with the sarcopenia program now Phase 3 ready to start. The compound is also being developed for metabolic disorders, with an obesity program Phase 2 ready to start.

Company Leadership Perspective

"We are delighted to achieve both EMA and Belgian regulatory clearance for our pivotal Phase 3 sarcopenia trial," said Stanislas Veillet, Chief Executive Officer of Biophytis. "This marks a significant milestone in our commitment to bringing effective therapies to those suffering from muscle loss due to aging."

Company Background

Biophytis SA is a clinical-stage biotechnology company focused on developing drug candidates for age-related diseases. The company is headquartered in Paris, France, with subsidiaries in Cambridge, Massachusetts, USA, and Brazil. The company's ordinary shares are listed on Euronext Growth Paris (ALBPS - FR001400OLP5) and its ADS (American Depositary Shares) are listed on the OTC market (BPTSY - US 09076G401).