Icovamenib

In a rodent model of type 2 diabetes (T2D), icovamenib in combination with low-dose semaglutide promoted enhanced glycemic control and body weight reduction with complete preservation of lean mass, outperforming the group given semaglutide alone Icovamenib promoted healthy myotube morphology and diminished drug-induced atrophy in ex vivo 3D-engineered human myotube cultures In severely insulin-deficient patients from the Phase II COVALENT-111 trial, icovamenib achieved a 1.0% placebo-adjusted mean HbA1c reduction and a 55% increase in C-peptide at Week 26, three weeks after last dose June 23, 2025 -- Biomea Fusion, Inc. (Biomea or Biomea Fusion) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced the presentation of new preclinical and clinical data for icovamenib, the company’s investigational oral menin inhibitor, at the 85th Scientific Sessions of the American Diabetes Association (ADA) June 20–23, 2025 in Chicago. Biomea presented three abstracts: one oral presentation and two posters, all highlighting icovamenib’s therapeutic potential across key dimensions of T2D pathophysiology, including its impact on beta cell restoration, and synergy with glucagon-like peptide-1 (GLP-1) receptor agonists (RA) to promote metabolic health and selective fat loss with complete lean mass preservation. “Our latest data from ADA 2025 reinforces icovamenib’s differentiated therapeutic profile and highlights the potential of menin inhibition as a novel mechanism of action that can be integrated with various antihyperglycemic agents, including GLP-1-based therapies,” said Ramses Erdtmann, President and Chief Operating Officer of Biomea Fusion. “The studies presented at ADA demonstrate that icovamenib enhanced glycemic control and drove additional weight loss when used in combination with GLP-1 therapies, while fully preserving lean mass. We believed these attributes set icovamenib apart in the diabetes landscape and support its potential to transform care for millions of patients.” Poster Presentation #870-P Title: Combination Therapy of Icovamenib and Semaglutide Enhances Body Weight Loss and Glycemic Control While Preserving Lean Mass in a Type 2 Diabetes Animal Model Summary: In a Zucker Diabetic Fatty (ZDF) rat model of T2D, treatment of icovamenib in combination with low-dose semaglutide (0.02 mg/kg) delivered superior metabolic benefits compared to low-dose semaglutide alone: 60% lower fasting blood glucose and 50% lower glucose OGTT AUC Greater HbA1c decline; >1% by Day 28 and >2% by Day 39 Greater improvement in insulin sensitivity with a 75% lower HOMA-IR (marker of insulin resistance) 2-fold increase in C-peptide to glucose ratio indicating enhanced beta cell function Superior appetite suppression with a 10% greater body weight reduction than low-dose semaglutide alone The observed body weight loss was primarily due to fat mass reduction with complete preservation of lean mass These findings support the potential of icovamenib to enhance the therapeutic effects of GLP-1-based therapies. The combination may allow lower doses of GLP-1-based therapies to achieve glycemic and weight loss targets and improve tolerability of these agents, offering a compelling rationale for clinical evaluation of icovamenib-based combination regimens. Title: Icovamenib Rescues Human Myotube Atrophy Ex Vivo and Displays Complete Lean Mass Preservation in a Type 2 Diabetes Rat Model Summary: This preclinical study evaluated icovamenib’s direct effects on ex vivo human myotube cultures and the effects of icovamenib in combination with low-dose semaglutide in an in vivo rodent model of diabetes: In ex vivo cultures of iPSC-derived 3D-engineered human myotubes, icovamenib treatment promoted healthy myotube morphology Separately, icovamenib diminished drug-induced atrophy by activin A or dexamethasone, suggesting muscle health supporting effects of icovamenib In a ZDF rat study (data also in poster #870-P), combination treatment with icovamenib and low-dose semaglutide induced greater body weight reduction with complete preservation of lean mass, outperforming low-dose semaglutide These early findings support icovamenib’s unique potential when combined with GLP-1-based therapies to enhance body weight reduction and protect lean mass, a highly desirable feature for any long-term diabetes or obesity therapy. Title: COVALENT-111: 26-Week Efficacy and Safety after 8 and 12 Weeks of Daily Oral Icovamenib in Patients with Poorly Controlled Type 2 Diabetes Summary: 26-week follow-up results from the ongoing Phase II COVALENT-111 trial highlight the potential of short-course oral icovamenib treatment (8 or 12 weeks) to deliver durable glycemic control and improved beta cell function, in patients with poorly controlled T2D, particularly in the insulin-deficient subgroup. Key findings include: Icovamenib achieved a 1.0% placebo-adjusted mean HbA1c reduction and a 55% increase in C-peptide in severe insulin-deficient participants at Week 26, three months after the last dose Over half of the C-peptide improvement occurred during the off-treatment period, indicating a durable effect on endogenous insulin production Short-course dosing (8 or 12 weeks) led to sustained HbA1c reductions through Week 26 across the broader study population Changes in HbA1c correlated significantly with changes in C-peptide, supporting the proposed mechanism of action to restore beta-cell function In patients inadequately controlled on baseline GLP-1 RA therapy, icovamenib added to the GLP-1 RA led up to an additional 1.0% mean HbA1c reduction Icovamenib was well tolerated across all dosing arms, with a low incidence of treatment-emergent adverse events (TEAEs), no clinically significant elevations in ALT or AST, and no study drug discontinuations or discontinuations from the trial due to adverse events These data reinforce icovamenib’s potential as a durable, disease-modifying treatment in T2D, both as monotherapy and in combination with existing agents such as GLP-1 RAs. The three abstracts have been published in Diabetes, the peer-reviewed journal of the American Diabetes Association. Biomea remains committed to advancing novel therapies that improve patient outcomes in diabetes and obesity. Loss of functional beta cell mass and function is a core component of the natural history in both types of diabetes — type 1 diabetes (T1D) (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 therapeutic approach to potentially halt or reverse progression of T2D. 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 37 million people of all ages (about 11% of the United States population) have diabetes today. 96 million adults (more than one in three) have pre-diabetes, 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 dollar out of every four dollars in United States health care costs spent on caring for people with diabetes. Despite the current availability of many diabetes medications, there remain significant unmet needs in the treatment and care of patients with diabetes. Icovamenib is an investigational, orally bioavailable, potent, and selective covalent inhibitor of menin. The molecule was built using Biomea’s FUSION™ System and is designed to regenerate insulin-producing beta cells with the aim to cure diabetes. Icovamenib’s proposed mechanism of action in diabetes is to enable the proliferation, preservation, and reactivation of a patient’s own healthy, functional, insulin-producing beta cells. As the potentially first disease-modifying therapy for T1D and T2D, icovamenib could become an important addition and complement to the diabetes treatment landscape once it has successfully completed its ongoing clinical studies and received regulatory approval. Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecules, icovamenib and BMF-650, both designed to significantly improve the lives of patients with diabetes, obesity, and metabolic diseases. The content above comes from the network. if any infringement, please contact us to modify.

REDWOOD CITY, Calif., June 17, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, announced today that it has commenced an underwritten public offering of shares of its common stock and accompanying warrants to purchase shares of its common stock (or pre-funded warrants in lieu thereof) and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock and accompanying warrants to purchase shares of its common stock (or pre-funded warrants in lieu thereof). In addition, Biomea intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock and pre-funded warrants offered in the public offering. All of the shares, pre-funded warrants and accompanying common stock warrants to be sold in the proposed offering are to be sold by Biomea. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering. The offering is expected to close on or about June 20, 2025, subject to the satisfaction of customary closing conditions. Jefferies is acting as sole book running manager for the proposed offering. The shares of common stock, pre-funded warrants, common stock warrants and shares of common stock issuable upon the exercise of the pre-funded warrants and common stock warrants are being offered by Biomea pursuant to an effective shelf registration statement on Form S-3 (File No. 333-267884), filed with the U.S. Securities and Exchange Commission (“SEC”) on October 14, 2022 and declared effective on October 24, 2022. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the proposed offering will be filed with the SEC and may also be obtained, when available, from: Jefferies LLC by mail at Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at prospectus_department@jefferies.com or by accessing the SEC’s website at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Biomea Fusion Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecules, icovamenib and BMF-650, both designed to significantly improve the lives of patients with diabetes, obesity, and metabolic diseases. Visit us at biomeafusion.com and follow us on LinkedIn, X and Facebook. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Biomea’s beliefs and expectations regarding the proposed public offering; uncertainties related to market conditions and statements regarding timing, size and expected proceeds of the proposed offering, and Biomea’s research, development and regulatory plans, the progress of ongoing and upcoming clinical trials and the timing of such events. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to completion of the public offering on the anticipated terms, or at all, market conditions and statements regarding the timing, size and expected gross proceeds of the offering, the grant to the underwriters of the option to purchase additional shares, the satisfaction of customary closing conditions related to the offering and sale of securities and Biomea’s ability to complete the offering. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Biomea’s most recent annual report on Form 10-K filed on March 31, 2025 and subsequent quarterly reports on Form 10-Q filed with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Biomea’s other filings with the SEC, including those contained or incorporated by reference in the preliminary prospectus supplement and accompanying prospectus related to the proposed offering to be filed with the SEC. Any forward-looking statements contained in this press release represent Biomea’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Biomea explicitly disclaims any obligation to update any forward-looking statements, except as required by law. 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