Press release
Page 1
Biomea Fusion Announces Positive 52-Week Results from Phase II COVALENT-111 Study in Type 2 Diabetes Demonstrating Non-Chronic Treatment with Icovamenib Benefits Two Distinct Patient Populations October 6, 2025 Icovamenib showed a sustained treatment benefit at Week 52 (9 months past the end of treatment) in the severe insulin- deficient diabetes patient population taking one or more antihyperglycemic medications at baseline, with a 1.8% placebo adjusted mean reduction in HbA1c (Arm B) Type 2 diabetes patients on a GLP-1-based therapy failing to achieve their target HbA1c also showed a clinically meaningful response from only 12 weeks of icovamenib treatment with a mean placebo adjusted HbA1c reduction of 1.8% (Arms A, B, and C combined) at Week 52 Icovamenib was generally well tolerated across all dosing arms and demonstrated a favorable safety and tolerability profile through Week 52 Phase II trials in severe insulin-deficient diabetes patients and diabetes patients not achieving glycemic target with a GLP-1-based therapy are expected to begin in the fourth quarter of 2025 Company to host a conference call to discuss results on Tuesday, October 7 at 8:30 am ET SAN CARLOS, Calif., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today announced positive 52-week results from its Phase II COVALENT-111 study evaluating the efficacy, safety, and tolerability of icovamenib in patients with type 2 diabetes (T2D). “We are encouraged by the durability of icovamenib’s effect observed nine months post-dosing at Week 52,” said Mick Hitchcock, Ph.D., Interim CEO and Board Member of Biomea Fusion. “We believe that we now have in hand initial evidence of durable efficacy, additional favorable safety data, a clear understanding of an effective dose, and most importantly, the target patient populations. Icovamenib demonstrates potential to transform the diabetes treatment landscape by effectively addressing the underlying biology.” COVALENT-111 Study Design COVALENT-111 is a double-blind, randomized, placebo-controlled trial that enrolled adult patients diagnosed with T2D within the last 7 years. Eligible participants had HbA1c levels between 7.0% and 10.5%, and a body mass index (BMI) between 25 and 40 kg/m². At baseline, all participants were treated with lifestyle management, including diet and exercise, with or without antidiabetic medications and had inadequate glycemic control despite treatment with up to three antidiabetic medications. The study evaluated icovamenib in three dosing regimens: Arm A at 100mg QD (once daily) for 8 weeks, Arm B at 100mg QD for 12 weeks, and Arm C at 100 mg QD for 8 weeks and 100mg BID (twice daily) for 4 weeks. A total of 267 patients received at least one dose of icovamenib and were considered evaluable for the modified intent-to-treat (mITT) population. As previously reported, dosing was interrupted by an interim clinical hold imposed by the U.S. Food and Drug Administration (FDA). The topline efficacy analysis presented here includes the patient population (N=163) who had completed at least 80% of their planned dosing prior to the clinical hold (without other significant protocol deviations) and who, at baseline, were treated with one or more antihyperglycemic agents. As prespecified in the statistical analysis plan, outcomes were prospectively evaluated by diabetes phenotype using the Ahlqvist algorithm. The study showed positive results, while exploratory, through Week 52 across multiple subgroups, with certain groups demonstrating statistically significant and clinically meaningful reductions in HbA1c, the gold standard for assessing glycemic control in T2D, observed nine months after dosing. In the 26-week analysis, 8 weeks of dosing was found to be less effective than 12. Accordingly, the 52-week readout primarily focused on patients in Arms B and C who received 12 weeks of treatment (n=10). Among these severe insulin-deficient patients, icovamenib achieved a durable HbA1c reduction of 1.2% (p=0.01) sustained through Week 52. The strongest performing arm for this prespecified population was Arm B (n=6; 100mg QD for 12 weeks), with a mean HbA1c reduction of 1.5% (p=0.01). Severe insulin-deficient diabetes is characterized by impaired insulin secretion, the lowest beta cell function among T2D subtypes, and rapid disease progression. This group was prospectively defined prior to unblinding and represents a population with substantial unmet need. The 52-week analysis also showed clinically meaningful benefit in study participants who were receiving a GLP-1-based therapy but had not achieved glycemic targets at study entry (all arms n=11). In this subgroup, 8 or 12 weeks of icovamenib resulted in a 1.3% reduction in HbA1c (p=0.05) with effects sustained through Week 52. Icovamenib maintained a favorable safety profile throughout the 52-week observation period. There were no treatment-related serious adverse events or discontinuations due to adverse events. Across all dosing arms, icovamenib was generally well tolerated. “The 52-week durability in severe insulin-deficient patients is remarkable. These are the most difficult to treat patients, and no current therapy provides
Page 2
this kind of lasting benefit for them without chronic dosing,” said Professor Ralph DeFronzo, M.D., University of Texas Health Science Center. “The HbA1c reductions we are seeing in this study readout, sustained long after the treatment had stopped, suggest a restoration of beta cell function. I believe icovamenib represents a major advancement, with the potential to become a new pillar of diabetes care as it addresses the root cause of diabetes, the dysfunction of beta cells. Of note, and also very exciting, is the interplay with GLP-1 based agents, whereby icovamenib seems to have given renewed impact to these agents.” Planned Next Steps Food Effect Study (COVALENT-121) is ongoing, to optimize the dosing criteria for icovamenib, and expected to be completed by December 2025 Phase IIb trial (COVALENT-211) in severe insulin-deficient type 2 diabetes patients, is expected to be initiated in the fourth quarter of 2025 Phase II trial (COVALENT-212) with GLP-1 based therapy in type 2 diabetes patients, is expected to be initiated in the fourth quarter of 2025 Phase I trial (GLP-131) Biomea’s oral GLP-1 RA (BMF-650) in obese, otherwise healthy volunteers, initiation is ongoing, and data anticipated in the first half of 2026 Conference Call and Webcast Details Webcast of Biomea’s investor update on Tuesday, October 7, 2025, at 8:30 am ET will be available to registered attendees under the Investors and Media section of the company’s website at https://investors.biomeafusion.com/news-events/events. A replay of the presentation will be archived on Biomea’s website following the event. About Icovamenib Icovamenib is an investigational, orally bioavailable, potent, and selective covalent inhibitor of menin. The proposed mechanism of action for icovamenib in diabetes is selective and partial inhibition of menin, a regulator of beta cell quantity and function, thereby enabling the proliferation, preservation, and reactivation of a patient’s own healthy, functional, insulin-producing beta cells. As the first non-chronic therapy for T2D, icovamenib could become an important addition to the diabetes treatment landscape once it has successfully completed its ongoing clinical studies. About Menin’s Role in Diabetes Loss of functional beta cell mass is a core component of the natural history in both types of diabetes — type 1 diabetes (mediated by autoimmune dysfunction) and T2D (mediated by metabolic dysfunction). Beta cells are found in the pancreas and are responsible for the synthesis and secretion of insulin. Insulin is a hormone that helps the body use glucose for energy and helps control blood glucose levels. In patients with diabetes, beta cell mass and function have been observed to be diminished, leading to insufficient insulin secretion and hyperglycemia. Menin is thought to act as a brake on beta cell turnover and growth, supporting the notion that inhibition of menin could lead to the regeneration of normal, healthy beta cells. Based on these and other scientific findings, Biomea is exploring the potential for icovamenib-mediated menin inhibition as a viable therapeutic approach to treat T2D. About Type 2 Diabetes and Severe Insulin-Deficient Diabetes Diabetes is considered a chronic health condition that affects how the body turns food into energy and results in excessive glucose in the bloodstream. Over time, this can cause serious health problems and damage vital organs. Most people with diabetes have a shorter life expectancy than people without this disease. The Centers for Disease Control and Prevention estimates about two in five adults in the United States are now expected to develop diabetes during their lifetime. More than 38 million people of all ages (about 11% of the US population) have diabetes today. 98 million adults (more than one in three) have prediabetes, blood glucose levels that are higher than normal but not high enough to be classified as diabetes. Diabetes is also one of the largest economic burdens on the United States health care system with one out of every four dollars in US health care spending on caring for people with diabetes. Despite the current availability of many diabetes medications, there remains a significant need in the treatment and care of patients with diabetes. Within the population of people with T2D, severe insulin deficient diabetes is a clinically recognized subtype of T2D characterized by profoundly impaired insulin secretion (significantly reduced beta cell function) and poor glycemic control. People with diabetes with severe insulin deficiency often present with higher HbA1c levels at diagnosis, lower body mass index compared to insulin-resistant patients, and a rapid decline in beta cell function. This group represents a very high unmet medical need, with the highest risk of complications such as retinopathy and neuropathy, and typically progresses the fastest to insulin therapy. Addressing the underlying beta cell dysfunction in this population offers an important opportunity to slow or potentially reverse disease progression. 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 www.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 the potential of icovamenib as a treatment for T1D and T2D, and our expectations regarding the optimal dose and target patient population; our research, development and regulatory plans; the mechanism of action of our product candidates and development programs; the progress and initiation of our
Page 3
ongoing and upcoming clinical trials, including our Food Effect Study (COVALENT-121), the initiation of our Phase IIb trial (COVALENT-211) in severe insulin-deficient type 2 diabetes patients, to initiate in fourth quarter of 2025 and the initiation of our Phase II trial with GLP-1 therapy (COVALENT-212) in type 2 diabetes patients, in the fourth quarter of 2025; the anticipated availability of data from our clinical trials; our planned interactions with regulators, and the 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 in 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