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Icovamenib Treatment in Patients with Severe Insulin-Deficient Diabetes Led to a Significant Improvement in Pancreatic Beta-cell Function with a 53% Mean Increase in C-peptide Levels 3 Months After Last Dose
BMEABiomea Fusion(BMEA) GlobeNewswire·2025-03-24 12:30

Core Insights - Biomea Fusion, Inc. presented promising preclinical and clinical data on icovamenib at the ATTD 2025 Conference, indicating its potential as a first-in-class, disease-modifying therapy for diabetes by targeting beta-cell restoration and enhancing insulin secretion [1][2][3] Company Overview - Biomea Fusion is a clinical-stage company focused on developing oral covalent small molecules aimed at improving the lives of patients with diabetes, obesity, and metabolic diseases [18] - The company utilizes its proprietary FUSION™ System to discover and develop next-generation covalent-binding small-molecule medicines [19] Product Insights - Icovamenib is an investigational covalent menin inhibitor designed to restore pancreatic beta-cell mass and function, which are critical in insulin-deficient diabetes [3][17] - The therapy demonstrated a significant increase in C-peptide production, indicating improved beta-cell function, with effects lasting beyond the treatment period [2][4][14] - A strong correlation was observed between C-peptide increase and HbA1c reduction, supporting icovamenib's proposed mechanism of action [6][14] Clinical Findings - Patients with severe insulin-deficient diabetes showed a 53% mean increase in C-peptide index levels by Week 26 after receiving icovamenib [14] - The treatment resulted in a statistically significant placebo-adjusted mean reduction in HbA1c of 1.47% at Week 26 [6] - Icovamenib enhanced the responsiveness of human islets to GLP-1-based medicines, suggesting potential for combination therapy [6][14] Market Context - Severe insulin-deficient diabetes is an underserved patient population, estimated to affect over 100 million people worldwide [6] - The findings from icovamenib's studies could address a significant unmet need in diabetes treatment, particularly for patients with poor beta-cell function [2][4][10]