Biomea Fusion Announces Initial Positive Data in Phase 2 Diabetes Trial

Biomea Fusion (Nasdaq: BMEA) has announced initial positive topline data for the first two cohorts of patients enrolled in the Phase 2 portion of its ongoing Phase 1/2 clinical study.

The study, COVALENT-111, is evaluating the company’s lead candidate, BMF-219, for the treatment of Type 2 diabetes. Biomea plans to explore the potential clinical utility of BMF-219 in other diabetic patient populations, including type 1 diabetes.

Highlights

• COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase 1/2 study. Healthy subjects were enrolled in the Phase 1 portion and Phase 2 consists of adult patients with uncontrolled type 2 diabetes.
• In Cohort 3, dosed at 100mg daily, 89% of patients achieved a reduction in A1c, 78% of patients achieved at least a 0.5% reduction in A1c, and 56% achieved at least a 1% reduction in A1c after 4 weeks.
• Initial observations of continued glycemic control were seen in follow up visits in patients at week 8 in the study.
• BMF-219 inhibits menin, a key inhibitory regulator that limits beta cell recovery in the pancreas, allowing for the regeneration, reactivation, and preservation of beta cells.
• This is the first clinical observation of patients with diabetes having a robust glucose-lowering response driven by an investigational menin inhibitor with a potentially disease-modifying mechanism of action.
• BMF-219 was generally well tolerated and there were no serious adverse events.

 About Biomea Fusion

Biomea Fusion is a clinical stage biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases. The company is utilizing its proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small molecule medicines designed to maximize clinical benefit for patients with various cancers and metabolic diseases, including diabetes.