Biophytis SA has unveiled its clinical strategy for a Phase 2 trial of BIO101, targeting muscle wasting in obese patients across Brazil and Europe. The randomized, double-blind, placebo-controlled study will recruit 164 participants, with 122 patients in Brazil and 42 in Europe, strategically positioned to accelerate development while enabling early regulatory engagement.
Addressing a Massive Unmet Medical Need
The global prevalence of obesity affects over 1 billion people worldwide, including approximately 150 million adults in Europe and nearly 70 million in Brazil. Muscle wasting in obesity, known as sarcopenic obesity, affects an estimated up to 40% of obese individuals, translating into several tens of millions of patients across target regions.
"BIO101 has already demonstrated its potential in age-related sarcopenia, and we now see the opportunity to extend its benefits to the vast, underserved population of obese patients suffering from muscle decline," said Stanislas Veillet, President and CEO of Biophytis.
Strategic Geographic Selection
The trial's geographic distribution reflects a carefully planned approach to maximize both recruitment efficiency and regulatory positioning. Brazil offers rapid recruitment potential in a large target population, where Biophytis has already established an exclusive license agreement with Blanver for Latin America. The European component enables early interaction with European regulators and positions BIO101 for future EU filings.
Significant Market Opportunity
Direct healthcare costs associated with obesity and related functional decline exceed hundreds of billions of euros annually across OECD countries, with muscle wasting and loss of mobility emerging as major cost and disability drivers. By focusing BIO101 on the intersection of metabolic and muscular health, Biophytis is positioning itself in a first-in-class therapeutic field, with potential addressable markets estimated in the multibillion-euro range globally.
Development Timeline and Funding Strategy
Biophytis is advancing toward trial initiation with key milestones including completion of regulatory approvals in Europe through EMA CTA and in Brazil with ANVISA IND processes. The company is finalizing agreements with leading clinical centers in both regions to accelerate patient recruitment.
The funding strategy leverages a diversified model including non-dilutive public financing programs, combined with private and institutional capital. These milestones are expected to generate upcoming value catalysts as Biophytis expands its addressable markets and establishes BIO101 as a potential first-in-class therapy for muscle wasting in obesity.
BIO101 (20-hydroxyecdysone) is a small molecule currently in Phase 3-ready development for sarcopenia and now advancing into Phase 2 for obesity-related muscle decline, representing a significant expansion of the therapeutic potential for Biophytis's lead candidate.
