Biomea Fusion Announces Research Collaboration with University of Leicester to Evaluate Icovamenib in Combination with Semaglutide in Obesity
- Collaboration will Assess the Potential Impact of the Combination of Icovamenib and Semaglutide on Physical Function, Body Weight, Body Composition, Muscle Health and Metabolic Outcomes
- Late-Breaking Preclinical Findings at the American Diabetes Association Annual Meeting June 5-8 Highlighting Potential Mechanisms through which Icovamenib may Support Metabolic Health
SAN CARLOS, Calif., June 03, 2026 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ("Biomea," "Biomea Fusion" or "the Company") (NASDAQ:BMEA), a clinical-stage diabetes and obesity company, today announced a collaboration with the University of Leicester as part of the ongoing platform research study titled Investigating and Optimizing Physical Function with Weight Loss: A Multi-Arm Open Label Adaptive Platform Trial (OPAL) which is being led by Professors Melanie Davies and Thomas Yates at the University of Leicester and Leicester Diabetes Centre (LDC).
The collaborative study will be activated within OPAL and will evaluate Biomea's investigational menin inhibitor, icovamenib, in combination with semaglutide in order to assess if adding icovamenib to the GLP-1 therapy will enhance the body weight lowering effects of semaglutide.
The newly activated experimental arm will evaluate the effects of icovamenib (100 mg, QD for 12 weeks) in combination with low-dose semaglutide (for 24 weeks) versus low-dose semaglutide alone (for 24 weeks) in individuals without type 2 diabetes that are either overweight (with 1 or more weight-related complications) or obese. This randomized and double blinded study will begin enrollment in the third quarter and will assess the combination therapy with the primary outcome assessment to be performed at Week 24.
"We are pleased to expand the OPAL platform study to include the evaluation of icovamenib in combination with semaglutide," said Professor Melanie Davies, CBE, Professor of Diabetes Medicine, University of Leicester, and Co-Founder of the LDC. As weight loss therapies continue to evolve, there is growing recognition that meaningful clinical benefit extends beyond reductions in body weight alone. Preserving physical function, muscle mass, and metabolic health is increasingly important for long-term patient outcomes. Preclinical data with icovamenib have demonstrated encouraging synergistic effects with semaglutide, including enhanced weight loss and potential benefits on bone and muscle biology, which we are now excited to explore in a clinical setting."
"This study is designed to address one of the key unanswered questions in obesity treatment- how to optimize weight loss while preserving lean mass and functional health," said Professor Thomas Yates, Professor of Physical Activity, Sedentary Behaviour and Health, University of Leicester, and LDC. "While GLP-1–based therapies have transformed the treatment landscape, there is increasing focus on their impact on lean mass, bone integrity, and functional capacity. The combination of icovamenib with semaglutide offers a compelling approach to potentially enhance weight loss while supporting muscle and skeletal health."
"By incorporating detailed assessments of body composition, physical function, and metabolic outcomes, this trial will generate important insights into how we can deliver more comprehensive and sustainable benefits for patients."
"We are excited to collaborate with Professor Davies, Professor Yates, and the team at the Leicester Diabetes Centre on this important addition to the OPAL platform study," said Thorsten Kirschberg, PhD, EVP of Research at Biomea Fusion. "Compelling preclinical data demonstrating synergistic effects between icovamenib and semaglutide gave us conviction that this combination has the potential to deliver meaningful benefits beyond weight loss alone. This collaboration enables us to rigorously evaluate that hypothesis in the clinic, including its impact on body composition, muscle, and bone health. We are excited to work with one of Europe's leading centers in metabolic research to generate insights that could help redefine how combination therapies are used to optimize patient outcomes."
The activation of this new treatment arm is supported by preclinical evidence showing icovamenib combined with low-dose semaglutide enhanced weight reduction driven by fat loss while preserving lean mass and improving glycemic control in a type 2 diabetic rat model.
Biomea will also present late-breaking preclinical findings at the 86th American Diabetes Association (ADA) Scientific Sessions highlighting potential mechanisms through which icovamenib may support metabolic health in a poster titled: Menin Inhibitor Icovamenib Activates Mechanisms That Support Metabolic Health poster #2871-LB to be presented on June 7, 2026 at 12:30 – 1:30 pm CT.
Collectively, the findings suggest that icovamenib activates complimentary biological pathways that support metabolic health and underscores its potential as a therapeutic approach for obesity in addition to diabetes. These observations support LDC's evaluation of icovamenib as part of a combination treatment strategy with GLP-based agents to explore its effect on metabolic health and physical function in overweight and obese patients.
About the OPAL Study
The OPAL study is an adaptive platform trial designed to investigate whether newer generations of weight loss therapies, as well as equivalent diet-induced weight loss, can improve overall physical function, as measured by walking performance and other validated assessments of muscle health. The study will also evaluate whether combining pharmacologic weight loss therapies with structured exercise programs can further enhance these benefits. Additional endpoints include changes in muscle and fat mass, blood-based markers of metabolic health, and patient-reported quality of life measures.
About The Leicester Diabetes Center
The Leicester Diabetes Centre (LDC) constitutes one of Europe's largest and preeminent facility for diabetes translational research, education, and clinical training. As a premier institution for diabetes and metabolic studies, it integrates world-class clinical care with an expansive, internationally recognized research infrastructure.
Established through a strategic partnership between the University Hospitals of Leicester National Health Service (NHS) Trust and the University of Leicester, the LDC facilitates a unique synergy between NHS clinicians, clinical researchers, and academic investigators within the University of Leicester Diabetes Research Centre.
About Icovamenib
Icovamenib is an orally administered investigational small molecule currently in Phase 2 clinical development for the treatment of diabetes. Icovamenib targets menin, a transcriptional regulator implicated in beta cell dysfunction, and has been shown preclinically in both animal models and ex vivo human islet microtissue culture studies to induce reductions in menin protein levels in pancreatic islets, and modulated pathways associated with beta cell proliferation and insulin production and secretion. Through these mechanisms, icovamenib has the potential to restore beta cell mass and function and improve glycemic control. As a potential short-course therapy, icovamenib could represent a novel treatment approach for patients with diabetes, particularly those who have not achieved adequate control with standard-of-care therapies.
About Biomea Fusion
Biomea Fusion is a clinical-stage biopharmaceutical company advancing oral small molecule therapies, icovamenib and BMF-650, for diabetes and obesity. These programs target metabolic disorders, a global health challenge affecting nearly half of Americans and one-fifth of the world's population. Biomea's mission is to deliver transformative treatments that restore health for patients living with diabetes, obesity, and related conditions. We aim to cure.
Visit us at biomeafusion.com and follow us on LinkedIn, X and Facebook.
Forward-Looking Statements
Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the clinical and therapeutic potential of our product candidates and development programs, including icovamenib and BMF-650, the potential of icovamenib as a treatment for type 2 diabetes and as a combination therapy with semaglutide to enhance metabolic health, the potential of BMF-650 as a treatment for obesity; our research, development and regulatory plans, the timing of initiation, patient enrollment and dosing, progress and availability of data from our clinical trials and the LDC's OPAL platform study; the mechanism of action of our product candidates and development programs; our engagement with regulatory authorities and collaboration with clinical and scientific experts; and the results and timing of such events may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that preliminary or interim results of preclinical studies or clinical trials may not be predictive of future or final results in connection with future clinical trials and the risk that we may encounter delays or adverse outcomes in regulatory interactions, preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea Fusion's business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission ("SEC"), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Contact:
Meichiel Jennifer Weiss
Sr. Director of Investor Relations and Corporate Development
ir@biomeafusion.com
