Biomea Fusion Completes Enrollment for 3 Arms in Phase 2 COVALENT-111 Study of BMF-219 for Type 2 Diabetes

Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company, recently announced the completion of patient enrollment for the first three dose expansion arms of its COVALENT-111 study. The study involves over 260 patients suffering from type 2 diabetes. The drug being tested, BMF-219, is an investigational novel covalent menin inhibitor aimed at regenerating insulin-producing beta cells.

COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II trial. The Phase I portion involved healthy participants to ascertain safety at different dosing levels. Phase II, which follows, includes multiple dose escalation and expansion cohorts of adult patients whose type 2 diabetes is not controlled by standard treatments. The dose escalation segment tested BMF-219 over a 4-week period, followed by 22 weeks of monitoring without treatment. The first three expansion arms (A, B, C) in Phase II are evaluating the drug over 8 and 12 weeks at dosages of 100 mg and 200 mg, with up to 40 weeks of follow-up.

Biomea Fusion's Chief Medical Officer, Juan Pablo Frias, MD, expressed excitement over the milestone. He highlighted that many participants in the dose escalation phase showed sustained glycemic control at Week 26, even after a short 4-week treatment period. Frias noted that BMF-219 is distinct because it tackles the root cause of diabetes by increasing the number of insulin-producing beta cells. He indicated that the longer dosing regimen in the expansion phase could potentially enhance these beneficial effects. The company plans to present the topline data from the first three expansion arms in the fourth quarter of 2024.

Further details about the Phase I/II clinical trial of BMF-219 can be accessed on ClinicalTrials.gov using the identifier NCT05731544.

Biomea Fusion specializes in the discovery and development of oral covalent small molecules for treating metabolic diseases and genetically defined cancers. Covalent small molecules form permanent bonds with their target proteins, offering advantages such as greater selectivity, lower drug exposure, and deeper, more durable responses compared to conventional drugs.

The company employs its proprietary FUSION™ System to design and develop a pipeline of innovative covalent-binding small molecule medications. The aim is to maximize clinical benefits and significantly impact the treatment of diseases affecting their patients. Biomea Fusion aspires to make transformative advancements in medical treatments and, ultimately, to find cures for these conditions.