Biomea Fusion Inc. (BMEA) announced that it has presented new data from its COVALENT-111 study evaluating Icovamenib for type-2 diabetes at the 23rd World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease or WCIRDC in Los Angeles.
COVALENT-111 is a double-blind, randomized, placebo-controlled trial that enrolled adults diagnosed with type-2 diabetes within the past seven years, who had inadequate glycemic control, despite lifestyle management and up to three antidiabetic medications.
Icovamenib is an investigational, orally bioavailable Menin inhibitor designed to restore pancreatic beta-cell function. By selectively inhibiting Menin, it aims to enable the proliferation and reactivation of insulin-producing cells in type-2 diabetes.
The study evaluated Icovamenib in three dosing regimens; Arm A at 100 mg QD (once daily) for 8 weeks, Arm B at 100 mg QD for 12 weeks, and Arm C at 100 mg QD for 8 weeks followed by 100 mg BID (twice daily) for 4 weeks.
Results showed durable glycemic and C-peptide improvements nine months after the last dose, with higher drug exposure linked to greater HbA1c reduction.
According to Biomea Fusion, the treatment effect persisted in patients who had failed prior GLP-1 therapy, delivering clinically meaningful improvements in glycemic control.
The company further said Icovamenib was generally well tolerated, with no treatment-related serious adverse events or discontinuations.
Biomea emphasized that the therapy represents a potential non-chronic approach aimed at restoring pancreatic beta-cell function in insulin-deficient type-2 diabetes.
Looking ahead, the company plans to initiate a Phase II b trial, namely COVALENT-211 in severe insulin-deficient type-2 diabetes and a Phase II trial of COVALENT-212 in combination with GLP-1 therapy, both expected to start in the fourth quarter of 2025.
BMEA is currently trading at $1.36, up 15.11%. Over the past 12 months the stock has traded between $0.87 and $6.57.
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