Biomea Fusion Reports New Preclinical Data on Icovamenib-Semaglutide Combination Study

• New in vivo preclinical data announced today, demonstrate that icovamenib, in combination with semaglutide showed additional 11.5% body weight reduction and 43% increase in lean muscle mass compared to semaglutide alone
• Icovamenib, in combination with semaglutide, approximately doubled C-peptide production per unit of glucose compared to semaglutide alone leading to a 60% improved reduction of fasting blood glucose
• Ex vivo human islet experiments previously presented in October, showed that icovamenib enhanced the activity of glucagon-like peptide-1 (GLP-1)-based therapies, leading to substantial increase in insulin secretion
• Topline data from the COVALENT-111 study showed that 12 weeks of daily icovamenib in patients uncontrolled on a GLP-1-based therapy (n=10) led to an HbA1c reduction of 0.84% at week 26
• Further data will be presented during the upcoming J.P. Morgan Conference January 13-15, 2025

REDWOOD CITY, Calif., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announce compelling results from in vivo studies of icovamenib in combination with semaglutide.

About the study:This preclinical study evaluated the efficacy of icovamenib, an investigational covalent menin inhibitor, in combination with a GLP-1 receptor agonist (i.e., semaglutide) to assess key metabolic parameters in animal models including: improvements in C-peptide index, a marker of insulin secretion and glucose regulation, blood glucose, HbA1c, insulin resistance (HOMA-IR) and beta cell function (HOMA-B), changes in body weight and composition, including fat and lean mass, and appetite suppression. Biomarkers were analyzed at multiple time points throughout a 28-day period. The study was conducted in two groups, one group of 10 Zucker Diabetic Fatty (ZDF) rats dosed with icovamenib (day 1 through day 28) in combination with semaglutide (day 14 through day 28) and a second group of 10 ZDF rats dosed with semaglutide alone (day 14 through day 28). ZDF rat is a type 2 diabetes animal model of insulin resistance.

Highlights of the Study:

Superior Glycemic Control:

• A 60% reduction in fasting blood glucose level was observed with combination therapy compared to semaglutide alone.
• A 50% reduction in area under the curve (AUC) was observed during the Oral Glucose Tolerance Test (OGTT) with combination therapy versus semaglutide alone, indicating improved glucose metabolism (p1%) compared to semaglutide alone (p