Biophytis Secures ANVISA Approval for Phase 2 OBA Trial of BIO101 in Obesity, Expanding Multi-Regional Development
核心洞察
Biophytis received ANVISA approval to launch the Phase 2 OBA clinical trial in Brazil, following prior authorizations in the United States and Europe.
The OBA study will evaluate BIO101 in 164 obese and overweight patients on GLP-1 therapy to assess its impact on muscle strength and mobility preservation.
BIO101 aims to address the unmet need of muscle mass and strength loss associated with GLP-1-induced weight reduction.
Biophytis SA (搜索), a clinical-stage biotechnology company focused on age-related diseases, announced on August 10, 2026, that it has received approval from Brazil's National Health Surveillance Agency (ANVISA) to commence the Phase 2 OBA clinical trial for obesity (搜索) in Brazil. The authorization, published in the Diário Oficial da União, represents a critical regulatory milestone that enables the company to proceed with operational implementation of the study in a region characterized by high obesity prevalence and growing unmet medical need.
The Brazilian approval follows regulatory green lights already obtained in the United States and Europe, underscoring Biophytis' capability to execute multi-regional clinical development in compliance with major health authority requirements.
Addressing a Critical Gap in GLP-1 Therapy
The global obesity (搜索) treatment market is undergoing rapid expansion, driven by the widespread adoption of GLP-1 receptor (搜索) agonists that deliver unprecedented weight loss. However, this therapeutic success comes with a significant limitation: GLP-1-induced weight loss is frequently accompanied by a marked reduction in muscle mass and strength, and these agents alone do not improve mobility in patients with obesity.
Biophytis is developing BIO101 (20-hydroxyecdysone), a small molecule drug candidate, to be used in combination with GLP-1-based therapies. The goal is to preserve muscle strength, restore mobility, and reduce the risk of sarcopenia (搜索) in patients undergoing pharmacologic weight loss.
Stanislas Veillet, Chairman and CEO of Biophytis, stated: "Obtaining this authorization from ANVISA, following those obtained in the United States and Europe, marks a pivotal milestone in the international rollout of our clinical trial for obesity (搜索). It thus strengthens our ability to execute an ambitious clinical strategy and address a new unmet medical need: improving mobility of obese patients in a rapidly expanding market."
OBA Study Design and Objectives
The OBA study is a Phase 2 clinical trial designed to evaluate BIO101 in 164 obese and overweight patients treated with GLP-1 receptor (搜索) agonists. The trial's primary objective is to measure improvements in lower-limb muscle strength, as assessed by the knee extension test. By combining BIO101 with GLP-1 therapy, the study aims to counteract the loss of muscle strength frequently observed during GLP-1-induced weight loss and to preserve mobility.
The study will be conducted across the United States, Europe, and Brazil, with enrollment scheduled to begin in early 2027.
Strategic Partnerships and Financial Framework
The OBA study operates under a licensing agreement with Blanver (搜索), one of the leading pharmaceutical companies in Brazil and Latin America, covering territories including Brazil, Mexico, Argentina, and Colombia. Under the terms of this partnership, Biophytis may receive up to €108 million, including an upfront payment and subsequent milestone payments upon achievement of certain objectives. Biophytis is also eligible to receive double-digit royalties on net sales in the relevant territory following future marketing authorizations.
Additionally, the company is receiving non-dilutive financial support from EMBRAPII (Farmavax), a Brazilian public agency dedicated to promoting industrial innovation. In the coming weeks, Biophytis will proceed to sign a contract with Blanver (搜索) and EMBRAPII to finalize preparations and launch the Phase 2 OBA trial at the primary investigator site while ensuring its co-financing.
Rebound Effect Amendment
Biophytis also announced plans to incorporate a rebound effect study into its protocol by submitting an amendment to regulatory agencies including the FDA, EMA, and ANVISA. This amendment aims to test BIO101's effect on weight gain during the rebound phase following discontinuation of GLP-1 therapy—a major risk and significant unmet medical need in current obesity (搜索) management.
Veillet further noted that the Brazilian approval "will enable us to position BIO101 for a second indication alongside its primary indication, which remains sarcopenia (搜索), with the support of the Brazilian pharmaceutical company Blanver (搜索), which is responsible for developing BIO101 in the region."
BIO101 is also in development for sarcopenia (搜索), with a Phase 3 program ready to start, positioning the compound across two indications within age-related and metabolic diseases.