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.