PIPELINE &
INNOVATION

Biomea Fusion is developing a new generation of small molecules to address metabolic diseases with high unmet need. Our goal is to restore metabolic function and improve long-term health outcomes.

Icovamenib

A New Approach in Diabetes Innovation

Icovamenib is an investigational, first-in-class therapy with a novel mechanism of action, being developed to address the underlying biology  of diabetes. Unlike conventional treatments that require chronic administration, icovamenib is intended to deliver a durable treatment effect by improving beta cell function and enhancing the incretin effect, supporting the body’s natural ability to regulate blood glucose.

This innovative therapy is administered orally once-daily for a defined 12-week period., offering a convenient and patient-friendly approach. In clinical studies to date, icovamenib has demonstrated the potential to enhance endogenous insulin production and improve markers of beta cell function*, supporting long-term metabolic health.

Beyond glucose control, icovamenib has also shown additional metabolic benefits in clinical and preclinical studies, including  reductions in body weight* and favorable effects on lean mass preservation in preclinical settings.

*Clinical results are based on preliminary findings.

Ongoing Clinical Development

Icovamenib is currently being evaluated in Phase II clinical trials:

  • COVALENT-211

    A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Icovamenib in Participants With Type 2 Diabetes Who Are Not Achieving Glycemic Targets.

  • COVALENT-212

    Phase 2 Randomized, Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Icovamenib in Participants With Type 2 Diabetes Not Achieving Glycemic Targets Despite GLP-1-Based Therapy.

BMF-650

A Next-Generation Oral Small Molecule GLP-1 Receptor Agonist

Biomea Fusion is prioritizing the development of BMF-650, an investigational, next-generation, oral small-molecule GLP-1 receptor agonist (GLP-1 RA), which has demonstrated positive, early preclinical activity, including improved glucose-stimulated insulin secretion, reduction in blood glucose concentration, appetite suppression and weight loss in cynomolgus monkeys.

BMF-650 is currently being evaluated in a Phase I clinical study in healthy participants.

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