
Biophytis gains IND approval from FDA for obesity study
Betsy Goodfellow | July 11, 2024 | News story | Medical Communications | Biophytis, IND, Obesity, clinical trial, obesity
Biophytis has announced that it has received investigational new drug (IND) approval from the US Food and Drug Administration (FDA) for its phase 2 OBA study in obesity with BIO101 (20-hydroxyecdysone).
The aim of the trial is to ‘measure the improvement in muscle strength in the lower limbs, as assessed by knee extension test. Secondary endpoints will include analysis of mobility (via the 6-minute walk test) and body composition (assessment of fat and lean mass)’, according to the press release.
The trial is due to begin in mid-2024 in the US, with potential expansions into Europe. Preliminary results are also expected in 2025 to evaluate the efficacy of BIO101.
Professor Marc-André Cornier, principal investigator on the trial, professor of medicine and director of the endocrinology, diabetes and metabolic diseases unit at the University of South Carolina, US, commented: “I am very happy that the IND for the phase 2 OBA clinical study with BIO101 (20-hydroxyecdysone) has been approved by the FDA. It is critical for us to study the safety and efficacy of new therapies designed to reduce the risk of muscle mass loss and resulting muscle weakness with functional consequences that may be associated with incretin-based therapies. Additionally, we might observe further weight loss over and above that obtainable with a GLP-1 RA.”
Betsy Goodfellow
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