Biomea Fusion, Inc. (NASDAQ:BMEA), currently trading at $2.67 after seeing its shares fall nearly 80% over the past year, reported new 52-week results Monday from its Phase II COVALENT-111 clinical trial evaluating icovamenib in adults with type 2 diabetes.
The COVALENT-111 trial is a double-blind, randomized, placebo-controlled study involving adults diagnosed with type 2 diabetes within the last seven years. Eligible participants had HbA1c levels between 7.0% and 10.5% and a body mass index between 25 and 40 kg/m². All participants had inadequate glycemic control despite lifestyle management and up to three antidiabetic medications. With a market capitalization of approximately $159 million, Biomea Fusion’s development programs are supported by a strong balance sheet, with InvestingPro analysis showing the company holds more cash than debt and maintains a healthy current ratio of 3.68.
The study assessed three dosing regimens of icovamenib: 100mg once daily for 8 weeks (Arm A), 100mg once daily for 12 weeks (Arm B), and 100mg once daily for 8 weeks followed by 100mg twice daily for 4 weeks (Arm C). A total of 267 patients received at least one dose and were included in the modified intent-to-treat population. Due to an interim clinical hold by the U.S. Food and Drug Administration, the topline efficacy analysis focused on 163 patients who completed at least 80% of their planned dosing.
The 52-week analysis primarily evaluated patients in Arms B and C who received 12 weeks of treatment (n=10) and were classified as having severe insulin-deficient diabetes. In this group, icovamenib achieved a mean reduction in HbA1c of 1.2% (p=0.01) sustained through Week 52. The greatest reduction was observed in Arm B (n=6), with a mean HbA1c decrease of 1.5% (p=0.01). In a subgroup of patients on GLP-1-based therapy who had not reached glycemic targets at study entry (n=11), icovamenib led to a 1.3% HbA1c reduction (p=0.05) sustained through Week 52.
The company reported that icovamenib maintained a favorable safety profile throughout the observation period, with no treatment-related serious adverse events or discontinuations due to adverse events.
Biomea Fusion stated that ongoing and upcoming studies include a food effect study (COVALENT-121) expected to complete by December 2025, and two Phase II trials (COVALENT-211 and COVALENT-212) planned to begin in the fourth quarter of 2025.
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