Biomea Fusion Inc. (BMEA), a clinical-stage diabetes and obesity company, on Friday announced new translational and Phase 2 data for Icovamenib in treating type-1 and type -2 diabetes. Data was presented at the scientific sessions of the American Diabetes Association (ADA).
Icovamenib is an orally administered investigational small molecule that inhibits menin to restore beta cell mass and improve glycemic control. The drug holds potential as a novel treatment for diabetes.
Translational data suggests that Icovamenib increases GLP-1 expression in human colon cell models and human islets. In human skeletal cells, the drug supported myogenic effects, while in human adipocytes, Icovamenib promoted browning and lipolysis. These findings indicated that Icovamenib activates complementary metabolic pathways that lead to glycemic control, fat reduction, and healthy muscle maintenance.
In the Phase 2 COVALENT-112 study evaluating Icovamenib in type-1 diabetes patients, C-peptide area under the curve (AUC) levels increased by a mean of 52%, compared to 47% in the placebo cohorts. The results suggest that the drug enhanced and preserved endogenous insulin secretion by improving residual beta cell function in type-1 diabetes patients.
The Phase 2 COVALENT-111 study evaluated Icovamenib in type-2 diabetes patients receiving GLP-1 RA therapy. The patients receiving treatment showed durable HbA1c reductions of 1.2%, compared to 0.6% in the placebo groups, and 1.8% reduction was observed in patients also on GLP-1 RA therapy.
Additionally, the company reported on BMF-650, an investigational, next-generation, oral small molecule GLP-1 RA developed for the treatment of obesity. The ongoing Phase 1 study for BMF-650 in overweight or obese participants completed testing the single ascending dose (SAD) cohort and four multiple ascending dose (MAD) cohorts. The company intends to add another MAD cohort to evaluate a one-step titration and further optimize weight reduction potential.
Initial 28-day Phase 1 data for BMF-650 is expected for the third quarter of this year.
BMEA closed Friday at
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