Biomea Fusion Starts New Trials to Test Diabetes Drug in Patients

Biomea Fusion, Inc. ("Biomea" or "Biomea Fusion" or "the Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity medicines company, today announced that the first patient has been dosed in its newly initiated Phase II programs, COVALENT-211 and COVALENT-212, evaluating icovamenib in patients with type 2 diabetes ("T2D"), marking a key step in advancing icovamenib into Phase II development in targeted patient populations failing standard-of-care therapies as established in the clinical trial COVALENT-111."These studies represent an important step forward as we advance icovamenib into later-stage Phase II development in the two clearly defined patient populations in which we had observed sustained glycemic improvements in our prior study. We are planning to enroll these two studies within the second quarter to achieve an initial readout before year-end." said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. "The design of COVALENT-211 and COVALENT-212 is informed by the durability, safety profile, and subgroup responses observed in our Phase II COVALENT-111 study, where we saw clinically meaningful glycemic improvements following a limited 12-week course of therapy with effects sustained nine months post the dosing period. These studies address patients who would otherwise require insulin therapy as one of their next therapeutic choices while existing alternatives are no longer providing glucose control. We believe icovamenib can provide significant benefits to these patients."Icovamenib's Phase II Diabetes Program - COVALENT-211 and COVALENT-212COVALENT-211 (NCT07502495) is evaluating icovamenib in adult patients with insulin-deficient T2D who are not achieving glycemic targets despite antihyperglycemic medications. Eligible participants must be on a stable dose of one to three antidiabetic therapies for at least three months prior to screening, with HbA1c levels between 7.5% and 10.5% and a body mass index (BMI) of ≤32 kg/m². Icovamenib is administered as an add-on to stable background therapy, which is maintained throughout the study unless rescue therapy is required.COVALENT-212 (NCT07502508) is evaluating icovamenib in adult patients with T2D who remain inadequately controlled while receiving GLP-1 ("RA")-based therapy but have not achieved glycemic targets. Eligible participants must be on a stable dose of GLP-1 therapy for at least three months prior to screening and may receive up to two additional background therapies (metformin and/or an SGLT2 inhibitor). Participants must have HbA1c levels ≥7.5% and ≤9.5% and a BMI between 25 and 40 kg/m². Icovamenib is administered as an add-on to stable GLP-1 RA-based therapy, which is maintained throughout the study unless rescue therapy is required.Both studies are planned to enroll approximately 60 participants each (2:1 randomization; icovamenib to placebo) across approximately 20 clinical sites. Participants will receive icovamenib 100 mg once daily or placebo for 12 weeks, followed by a 40-week off-treatment period designed to assess durability of glycemic control and beta-cell function beyond the dosing period, assessed at Week 26 (primary endpoint) and at Week 52 (secondary endpoint).Both studies incorporate key learnings from the Phase II COVALENT-111 study, including optimized dosing informed by the COVALENT-121 food-effect study and a focus on patient populations that demonstrated the most pronounced and durable responses. Topline data from both studies are anticipated in the fourth quarter of 2026. Together, these studies are designed to evaluate icovamenib's potential to restore beta-cell function across two clinically distinct, high-need T2D populations.Rationale for Targeted Patient PopulationsThe initiation of COVALENT-211 and COVALENT-212 builds on findings from the all-comers Phase II COVALENT-111 study in patients with T2D not achieving glycemic targets despite standard-of-care therapy. The data demonstrated durable and clinically meaningful reductions in HbA1c that persisted nine months after completion of a 12-week treatment course. The findings in the 52-week analysis include:In patients with severe insulin-deficient T2D receiving one or more antihyperglycemic agents at baseline, icovamenib achieved up to a placebo-adjusted 1.5% mean reduction in HbA1c (p=0.01) that was maintained through Week 52 following 12 weeks of dosing.In a subgroup of patients receiving GLP-1 RA-based therapy who had not achieved glycemic targets at study entry, icovamenib achieved a 1.8% placebo-adjusted mean reduction in HbA1c (p=0.05) that was maintained through Week 52 following 12 weeks of dosing.In both populations, icovamenib treatment was associated with increased C-peptide levels measured off treatment, supporting the proposed mechanism of action of restoration of beta-cell function.Icovamenib was generally well tolerated across all dosing arms, with no treatment-related serious adverse events or treatment discontinuations observed during the 52-week observation period.These data support the continued development of icovamenib as a potential therapy designed to address underlying beta-cell dysfunction and provide durable glycemic control following a three-month treatment period.