CLINICAL TRIALS

CLINICAL TRIALS - BIOMEA FUSION

Icovamenib is an investigational, orally administered small molecule designed to downmodulate menin, a transcriptional regulator implicated in beta-cell biology. Icovamenib is being developed as a potential disease-modifying therapy for type 1 and type 2 diabetes by targeting the underlying loss and dysfunction of insulin-producing beta cells.

Preclinical studies have demonstrated that icovamenib promotes glucose-dependent beta-cell proliferation and enhances insulin production and secretion. Clinical data generated to date support its potential to improve and preserve endogenous beta-cell function. Through these mechanisms, icovamenib is being evaluated for its potential to restore beta-cell mass and function and provide durable improvements in glycemic control.

Icovamenib is currently being evaluated in clinical studies in type 1 and type 2 diabetes, including Phase 2 studies designed to further characterize its potential as a differentiated and complementary approach within the diabetes treatment landscape. The clinical trials described below are being conducted by Biomea Fusion.

Current Clinical Trials for Icovamenib:

  • COVALENT-211 – Phase II Trial of Icovamenib in Participants with Insulin-Deficient Type 2 Diabetes – Study Ongoing
  • COVALENT-212 – Phase II Trial of Icovamenib in Participants with Type 2 Diabetes Uncontrolled with a GLP-1 RA-based Therapy – Study Enrolling
  • OPAL Study – Phase II Trial of Icovamenib in Combination with Low Dose Semaglutide to in Participants that are Overweight or Obese – 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 for BMF-650:
  • 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 – Study Ongoing
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