Biophytis Receives EMA and Belgian Regulatory Approval to Initiate Phase 3 Sarcopenia Clinical Trial
Biophytis announced that both Part I (European Medicines Agency scientific review) and Part II (Belgian national ethical assessment) of its Clinical Trial Application (CTA) for a Phase 3 study in sarcopenia have been successfully reviewed and accepted.
With these approvals, Biophytis is now authorized to initiate patient enrollment for the Phase 3 sarcopenia trial at selected sites in Belgium. The company will also collaborate with leading clinical centers across additional European Member States under the harmonized European framework.
“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.”
EMA Part I: Scientific & Methodological Approval
The European Medicines Agency (EMA) has 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.
Part II in Belgium: National Ethical Acceptance
Concurrently, Belgian authorities have concluded their Part II review, approving all national and ethical aspects of the study. This includes local considerations such as informed consent procedures, data protection, investigator qualifications, and safeguards for participant wellbeing.
The approval ensures that the trial will be conducted in compliance with Belgian regulations and to the highest ethical standards.