Biomea Fusion, Inc. has unveiled compelling clinical and translational data for its investigational therapies at the American Diabetes Association (ADA) 86th Scientific Sessions, held in New Orleans from June 5-8, 2026. The presentations focused on icovameniban oral menin inhibitor, and BMF-650an oral GLP-1 receptor agonistshowcasing their potential to address type 1 diabetes (T1D), type 2 diabetes (T2D), and obesity.
The data presented underscores Biomea’s commitment to developing innovative treatments for metabolic diseases. Mick Hitchcock, Ph.D.Interim Chief Executive Officer of Biomea Fusion, expressed optimism about the findings, stating that they strengthen confidence in icovamenib’s differentiated profile and its potential to address significant unmet needs in diabetes care.
Icovamenib’s potential in diabetes and metabolic health
New translational data presented by Mini Balakrishnan, Ph.D.demonstrated icovamenib’s ability to activate biological pathways associated with metabolic health. The findings suggest that icovamenib can enhance GLP-1 expression and GLP-1 receptor expressionsupporting its complementary use with GLP-1 RA-based therapies. Additionally, icovamenib promoted myogenic effects in human skeletal muscle cells and browning and lipolysis in human adipocytes, indicating its potential to support muscle health, fat reduction, and overall metabolic function.
Improvements in type 1 diabetes
Juan Pablo Frías, M.D.presented 52-week clinical findings from the Phase II COVALENT-112 study, which evaluated icovamenib in adults with T1D. The data showed that icovamenib was associated with enhancement and preservation of endogenous insulin secretion. Among Cohort 1 participants diagnosed with T1D for less than three years, 200 mg icovamenib increased C-peptide Area Under the Curve (AUC) by a mean of approximately 52% at Week 12 versus baseline. At Week 52, mean C-peptide AUC remained broadly preserved, compared with an approximately 47% annual decline reported in historical placebo cohorts. Cytokine profiling showed no evidence of systemic immune activation, with inflammatory markers remaining stable or reduced through Week 52.
Durable glycemic improvements in type 2 diabetes
Subgroup analyses from the Phase II COVALENT-111 study evaluated adults with T2D receiving background GLP-1 RA therapy who remained above glycemic targets at baseline. The findings demonstrated durable HbA1c improvements through Week 52, including 40 weeks after treatment discontinuation. Icovamenib-treated participants experienced a 1.2% HbA1c mean reduction at Week 52, compared to a 0.6% mean increase with placebo. This resulted in a clinically meaningful placebo-adjusted HbA1c mean reduction of 1.8% among participants inadequately controlled while receiving background GLP-1 RA therapy. Improvements in C-peptide index supported enhancement of endogenous insulin secretion and restoration of beta cell function.
Expanding the BMF-650 Phase I study
Biomea Fusion has expanded its ongoing Phase I GLP-131 study to evaluate a rapid one-step titration for BMF-650its investigational oral GLP-1 receptor agonist. The additional cohort will explore a titration schedule of 200 mg QD for 1 week, followed by 400 mg QD for 3 weeks, to further optimize its weight reduction potential. Initial 28-day clinical weight reduction data from the Phase I GLP-131 study is anticipated in the third quarter of 2026. To date, BMF-650 has demonstrated a favorable safety and tolerability profile across completed cohorts, with no dose-limiting toxicities observed.
The expanded study aims to provide further insight into the clinical profile of BMF-650 and support its development as a differentiated, next-generation oral GLP-1 receptor agonist for obesity and metabolic disease. Biomea’s development strategy for BMF-650 focuses on achieving consistent plasma levels and increased drug exposure to support a potential best-in-class profile among oral small-molecule GLP-1 therapies.
All abstracts presented at ADA will be published in the Diabetes® journal, and posters will be available on the Investors & Media section of Biomea’s website. Biomea Fusion remains committed to delivering transformative treatments that restore health for patients living with diabetes, obesity, and related conditions.
