BARCELONA, Spain, March 14, 2026
Clinical-stage biopharmaceutical company Biomea Fusion has reported encouraging 52-week follow-up results from its Phase II COVALENT-111 clinical study evaluating icovamenib in patients with type 2 diabetes (T2D). The data, presented at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) 2026, highlight durable glycemic control, improved insulin secretion, and a favorable safety profile, reinforcing the potential of the investigational therapy to address the underlying biology of diabetes. The findings suggest that icovamenib, a novel menin inhibitor, may help restore pancreatic beta-cell function and significantly improve blood glucose management in patients with difficult-to-treat diabetes.
Phase II Study Demonstrates Durable Glycemic Control
The COVALENT-111 study was designed as a randomized, double-blind, placebo-controlled clinical trial enrolling adult patients diagnosed with type 2 diabetes within the previous seven years who had inadequate glycemic control despite lifestyle interventions and standard antidiabetic medications. Participants had HbA1c levels between 7.0% and 10.5% and a body mass index ranging from 25 to 40 kg/m², reflecting a patient population with significant metabolic challenges.
A total of 267 patients received at least one dose of icovamenib, and the primary analysis focused on 163 participants who completed at least 80% of the planned dosing regimen prior to a temporary clinical hold imposed by the U.S. Food and Drug Administration. Patients were evaluated across multiple dosing regimens, including 100 mg once daily for eight weeks, 100 mg once daily for 12 weeks, and a combination of once-daily and twice-daily dosing.
The study demonstrated clinically meaningful reductions in HbA1c, the gold-standard marker for blood glucose control, with sustained improvements observed up to 52 weeks after treatment. Importantly, patients with severe insulin-deficient diabetes (SIDD) — a subtype characterized by rapid disease progression and impaired insulin secretion — experienced HbA1c reductions of up to 1.5% following 12 weeks of treatment, indicating a strong therapeutic response in a population with high unmet medical need.
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Evidence of Improved Beta-Cell Function
Beyond improvements in glucose control, the study also provided evidence that icovamenib may help restore pancreatic beta-cell activity, a critical factor in the progression of both type 1 and type 2 diabetes. Beta cells are responsible for producing insulin, the hormone that regulates blood sugar levels. Loss of beta-cell function is considered a key driver of diabetes progression.
Among patients with severe insulin-deficient diabetes, researchers observed a 24% increase in the C-peptide index, an indicator of endogenous insulin production, suggesting enhanced beta-cell activity following treatment. Additionally, individuals already receiving GLP-1-based therapies but failing to reach glycemic targets experienced HbA1c reductions of approximately 1.2% at Week 52, accompanied by a 35% increase in the C-peptide index, further supporting the therapy’s potential to improve insulin secretion.
The underlying mechanism of icovamenib involves targeting the protein menin, a transcriptional regulator that acts as a biological brake on beta-cell regeneration. By inhibiting menin activity, the therapy may enable beta-cell recovery and improved insulin production, representing a novel approach aimed at addressing the root cause of diabetes rather than only controlling symptoms.
Favorable Safety Profile and Future Development Plans
The Phase II study also confirmed a favorable safety and tolerability profile for icovamenib throughout the 52-week observation period. Researchers reported no treatment-related serious adverse events and no discontinuations due to adverse effects, suggesting the therapy may offer a well-tolerated treatment option for long-term diabetes management.
Encouraged by these results, Biomea Fusion plans to advance additional clinical studies to further evaluate icovamenib in targeted patient populations. Upcoming milestones include 52-week follow-up data from the COVALENT-112 trial in type 1 diabetes patients expected in the second quarter of 2026, as well as primary endpoint data from the Phase IIb COVALENT-211 and COVALENT-212 studies anticipated later in 2026.
In parallel, the company is also progressing BMF-650, another investigational therapy targeting obesity, with initial Phase I weight-reduction data expected in the second quarter of 2026. These programs reflect Biomea Fusion’s broader strategy to develop transformative therapies addressing metabolic disorders affecting millions of patients worldwide.
With diabetes affecting more than 38 million people in the United States alone and nearly one-fifth of the global population, innovative therapies capable of restoring insulin-producing cells and improving long-term metabolic health could significantly transform the treatment landscape. The positive Phase II results for icovamenib therefore represent an important milestone in the development of next-generation therapies aimed at potentially slowing or reversing disease progression in diabetes.
Source: Biomea Fusion press release
