Biophytis: application filed in obesity in the USA

(CercleFinance.com) - Biophytis announced Monday that it has filed an Investigational New Drug (IND) application with the US FDA for its Phase 2 study in obesity.


The biotech company says the trial aims to assess the efficacy and safety of BIO101, its lead drug candidate, in obese and overweight patients with comorbidities, treated for 21 weeks with weight-loss stimulating GLP-1 and following a hypocaloric diet.

The primary objective of the study is to evaluate improvements in
lower limb muscle strength, measured by knee extension.

Several secondary endpoints will also be explored, such as mobility (measured by the six-minute walk test) and body composition (fat mass, lean mass).

This international, multicenter, placebo-controlled study is due to start in mid-2024, after regulatory approval from the
FDA, with first results expected in 2025.

In its press release, Biophytis points out that over 15 million US adults are expected to be treated with anti-obesity drugs by 2030, i.e. 13% of the population, representing a potential market estimated at $100 billion.

It is crucial for Biophytis to position itself on this major medical challenge, which also presents great revenue potential", explains its CEO, Stanislas Veillet.

Following this announcement, the biotech's shares posted gains of over 3% on Monday morning on the Paris Bourse.

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