Biomea Fusion, a clinical-stage biopharmaceutical company, announced it will focus on developing treatments for diabetes and obesity, with its lead candidate icovamenib at the forefront. The strategic shift follows promising clinical trial results indicating icovamenib's potential in addressing metabolic disorders, particularly in insulin-deficient patients and in combination with GLP-1-based therapies.
Icovamenib's Clinical Promise
Icovamenib, a potential first-in-class menin inhibitor, has shown significant activity in patients with the lowest insulin production. Data from clinical trials revealed a placebo-adjusted 1.5% mean reduction in HbA1c in severely insulin-deficient patients uncontrolled on existing antidiabetic agents. Furthermore, icovamenib demonstrated a 1.0% placebo-adjusted mean HbA1c reduction in patients suboptimally controlled with GLP-1-based therapies, aligning with preclinical findings that suggest enhanced GLP-1 receptor expression and increased glucose-stimulated insulin secretion when combined with drugs like semaglutide.
Notably, the benefits of icovamenib were observed even after patients had been off treatment for 14 weeks following a 12-week dosing period. The drug was also well-tolerated, with no reported adverse-event related discontinuations, hypoglycemic events, or serious adverse events.
Targeting Insulin Deficiency
Biomea's focus will be on insulin-deficient patients, who represent approximately 20% of the type 2 diabetes population in the US and Europe. These patients typically have the lowest insulin production, highest unmet medical needs, and the worst cardiovascular outcomes. According to Biomea, these patients can be readily identified using HbA1c and BMI.
Thomas Butler, CEO of Biomea Fusion, stated, "We are excited to focus our efforts on metabolic disorders and to accelerate the development of icovamenib in 2025. Our decision reflects the significant potential we see in addressing the insulin deficient patients and those initiating or failing on a GLP-1-based therapy."
Upcoming Clinical Trials
Biomea plans to discuss its clinical development plan with the FDA to support the use of icovamenib in two specific patient groups. The company is planning two clinical trials:
- A Phase 2/3 adaptive design trial in insulin-deficient type 2 diabetes patients (HbA1c ≥8.5% and BMI <32 kg/m2) uncontrolled on current antidiabetic medication.
- A Phase 2b trial of icovamenib in combination with a GLP-1-based therapy in patients uncontrolled on or initiating GLP-1-based therapy.
Preclinical Synergies with GLP-1 Therapies
Preclinical in vivo studies have indicated that icovamenib, when combined with GLP-1-based therapies, demonstrates encouraging metabolic benefits, including superior glycemic control, enhanced beta cell function, significant body weight reduction, and improved lean muscle mass. These findings suggest that icovamenib could potentially enhance the efficacy of GLP-1 therapies and act as a disease-modifying agent.
Strategic Outlook
Biomea Fusion will present a corporate update at the 43rd Annual J.P. Morgan Healthcare Conference, detailing its plans for 2025 and beyond. The company aims to explore partnerships to further advance its oncology assets, while concentrating internal resources on metabolic disorders.
