Biomea Fusion announces presentation of icovamenib preclinical, clinical data

Biomea Fusion (BMEA) announced the presentation of new preclinical and clinical data for icovamenib, the company’s investigational oral menin inhibitor, at the 85th Scientific Sessions of the American Diabetes Association June 20-23, 2025 in Chicago. Biomea presented three abstracts: one oral presentation and two posters, all highlighting icovamenib’s therapeutic potential across key dimensions of T2D pathophysiology, including its impact on beta cell restoration, and synergy with glucagon-like peptide-1 receptor agonists to promote metabolic health and selective fat loss with complete lean mass preservation. Presentation Summaries: Title: Combination Therapy of Icovamenib and Semaglutide Enhances Body Weight Loss and Glycemic Control While Preserving Lean Mass in a Type 2 Diabetes Animal Model: Summary: In a Zucker Diabetic Fatty rat model of T2D, treatment of icovamenib in combination with low-dose semaglutide delivered superior metabolic benefits compared to low-dose semaglutide alone: 60% lower fasting blood glucose and 50% lower glucose OGTT AUC; Greater HbA1c decline; greater than1% by Day 28 and greater than2% by Day 39; Greater improvement in insulin sensitivity with a 75% lower HOMA-IR; 2-fold increase in C-peptide to glucose ratio indicating enhanced beta cell function; Superior appetite suppression with a 10% greater body weight reduction than low-dose semaglutide alone; The observed body weight loss was primarily due to fat mass reduction with complete preservation of lean mass; These findings support the potential of icovamenib to enhance the therapeutic effects of GLP-1-based therapies. The combination may allow lower doses of GLP-1-based therapies to achieve glycemic and weight loss targets and improve tolerability of these agents, offering a compelling rationale for clinical evaluation of icovamenib-based combination regimens. Title: Icovamenib Rescues Human Myotube Atrophy Ex Vivo and Displays Complete Lean Mass Preservation in a Type 2 Diabetes Rat Model: Summary: This preclinical study evaluated icovamenib’s direct effects on ex vivo human myotube cultures and the effects of icovamenib in combination with low-dose semaglutide in an in vivo rodent model of diabetes: In ex vivo cultures of iPSC-derived 3D-engineered human myotubes, icovamenib treatment promoted healthy myotube morphology; Separately, icovamenib diminished drug-induced atrophy by activin A or dexamethasone, suggesting muscle health supporting effects of icovamenib; In a ZDF rat study, combination treatment with icovamenib and low-dose semaglutide induced greater body weight reduction with complete preservation of lean mass, outperforming low-dose semaglutide; These early findings support icovamenib’s unique potential when combined with GLP-1-based therapies to enhance body weight reduction and protect lean mass, a highly desirable feature for any long-term diabetes or obesity therapy. Title: COVALENT-111: 26-Week Efficacy and Safety after 8 and 12 Weeks of Daily Oral Icovamenib in Patients with Poorly Controlled Type 2 Diabetes: Summary: 26-week follow-up results from the ongoing Phase II COVALENT-111 trial highlight the potential of short-course oral icovamenib treatment to deliver durable glycemic control and improved beta cell function, in patients with poorly controlled T2D, particularly in the insulin-deficient subgroup. Key findings include: Icovamenib achieved a 1.0% placebo-adjusted mean HbA1c reduction and a 55% increase in C-peptide in severe insulin-deficient participants at Week 26, three months after the last dose; Over half of the C-peptide improvement occurred during the off-treatment period, indicating a durable effect on endogenous insulin production; Short-course dosing led to sustained HbA1c reductions through Week 26 across the broader study population; Changes in HbA1c correlated significantly with changes in C-peptide, supporting the proposed mechanism of action to restore beta-cell function; In patients inadequately controlled on baseline GLP-1 RA therapy, icovamenib added to the GLP-1 RA led up to an additional 1.0% mean HbA1c reduction. Icovamenib was well tolerated across all dosing arms, with a low incidence of treatment-emergent adverse events, no clinically significant elevations in ALT or AST, and no study drug discontinuations or discontinuations from the trial due to adverse events