CLINICAL TRIALS

CLINICAL TRIALS - BIOMEA FUSION

Icovamenib is an investigational, orally bioavailable, potent, and selective covalent inhibitor of menin. The molecule was built using Biomea’s FUSION™ System and is designed to regenerate insulin-producing beta cells with the aim to cure diabetes. Icovamenib’s proposed mechanism of action in diabetes is to enable the proliferation, preservation, and reactivation of a patient’s own healthy, functional, insulin-producing beta cells. As the potentially first disease-modifying therapy for T1D and T2D, icovamenib could become an important addition and complement to the diabetes treatment landscape once it has successfully completed its ongoing clinical studies and received regulatory approval. The below clinical trials are being conducted by Biomea Fusion.

Current Clinical Trials

  • COVALENT-112 – Phase II Trial of Icovamenib in Participants with Type 1 Diabetes Mellitus – Study Ongoing
  • COVALENT-211 – Phase II Trial of Icovamenib in Participants with Insulin-Deficient Type 2 Diabetes – Study Enrolling
  • COVALENT-212 – Phase II Trial of Icovamenib in Participants with Type 2 Diabetes Uncontrolled with a GLP-1 RA-based Therapy – Study Enrolling

BMF-650 Clinical Trials

BMF-650 is an investigational, next-generation, oral small-molecule GLP-1 receptor agonist (GLP-1 RA). In preclinical studies, BMF-650 has demonstrated compelling activity, including improved glucose-stimulated insulin secretion, reductions in blood glucose concentration, appetite suppression, and robust weight loss in obese cynomolgus monkeys.

Current Clinical Trials:
  • GLP-131 – Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMF-650 in Otherwise Healthy Overweight or Obese Participants – Currently Enrolling
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