Biomea Fusion doses first patient in obesity combo drug study

Biomea Fusion, Inc. (Nasdaq: BMEA) announced that the first participant has been dosed in a new arm of the OPAL platform research study, evaluating its investigational compound icovamenib in combination with low-dose semaglutide in people who are overweight or obese without type 2 diabetes.

The study arm is being conducted in collaboration with the University of Leicester and the Leicester Diabetes Centre, led by Professor Dame Melanie Davies and Professor Thomas Yates, alongside the NIHR Biomedical Research Centre Leicester.

The randomized, double-blind study arm plans to enroll 64 participants split equally between two groups: one receiving icovamenib (100mg, once daily for 12 weeks) alongside low-dose semaglutide for 24 weeks, and one receiving low-dose semaglutide alone for 24 weeks. The primary endpoint will be assessed at week 24 and will evaluate effects on physical function, body weight, body composition, muscle health, and metabolic outcomes.

According to the press release, preclinical studies showed that icovamenib enhanced the efficacy of semaglutide, with improved weight reduction driven by fat loss while preserving lean mass. Additional preclinical data indicated that icovamenib upregulates GLP-1 expression, supports myogenesis, and shifts adipose tissue metabolism toward energy expenditure.

"This marks an important step in translating the encouraging preclinical findings with this combination into the clinical setting," said Professor Dame Melanie Davies.

Icovamenib is an orally administered small molecule currently in Phase 2 clinical development for type 1 and type 2 diabetes. The OPAL study is an adaptive platform trial designed to investigate whether weight loss therapies can improve physical function and muscle health.

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