Exhibit 99.1
Biomea Fusion to Become a Diabetes &
Obesity Medicines Company
January 13, 2025
Icovamenib & BMF-650 (oral small molecule
GLP-1) are the cornerstones
of the metabolic franchise
Biomea preparing icovamenib for late-stage clinical development
2025 corporate update to be presented at the 43rd Annual J.P. Morgan Healthcare
Conference
REDWOOD CITY, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) Biomea Fusion, Inc. (Biomea or Biomea Fusion or
the Company) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to improve the lives of patients announced today that the company will become a diabetes and
obesity medicines company. Based on the most recent clinical trial results, the strategic focus for icovamenib will be in metabolic disorders. The company will prioritize insulin deficient patients and combination strategies with GLP-1-based therapies for obesity and diabetes. Biomea plans to conclude its studies exploring icovamenibs potential in oncology and explore partnerships to further
advance its oncology assets, while concentrating internal resources on metabolic disorders.
Icovamenib, a potential first-in-class menin inhibitor for the treatment of diabetes, demonstrated the strongest activity in patients with the lowest insulin production
Placebo adjusted 1.5% mean reduction in HbA1c (a measure of blood glucose control) in severe insulin deficient patients uncontrolled on one or more
antidiabetic agents at baseline.
Icovamenib showed strong activity in patients uncontrolled on GLP-1-based therapies
Placebo adjusted mean HbA1c reduction of 1.0% in patients suboptimally controlled at
baseline with GLP-1-based therapies, consistent with preclinical findings demonstrating enhanced GLP-1 receptor expression and
increased glucose-stimulated insulin secretion with the combination of icovamenib and a GLP-1-based therapy such as semaglutide.
Icovamenib demonstrated statistically significant and clinically meaningful benefits validating the mechanism of action
Greater clinical benefits were achieved in patients who were most insulin deficient.
Icovamenib achieved these results while patients were off treatment for 14 weeks
Patients received icovamenib for only 12 weeks, with a primary follow up at Week 26.
Icovamenib was well tolerated and demonstrated a favorable safety profile
No adverse-event related discontinuations, hypoglycemic events, or serious adverse events were reported.
In the prespecified subgroup of severely insulin deficient patients, all patients (100%) responded to 100mg of icovamenib for 12 weeks, displaying a durable
reduction in HbA1c 14 weeks after treatment completion, with a continued decline in mean HbA1c while off therapy. In the United States and Europe, these patients represent approximately 20% of the type 2 diabetes patient population. They typically
have the lowest insulin production, highest unmet medical need, highest all-cause mortality and worst cardiovascular outcomes. These patients can be easily identified using their HbA1c and body mass index
(BMI). These results give us great hope to have identified a pathway with the potential to address diabetes at the root cause level, the depleted pool and function of beta cells. We plan to present further results of the COVALENT-111 trial at an upcoming medical conference.
In preclinical in vivo studies of icovamenib in
combination with GLP-1-based therapies, icovamenib demonstrated encouraging metabolic benefits, including superior glycemic control, enhanced beta cell function,
significant body weight reduction and improved lean muscle mass. We believe these findings not only underscore the potential for icovamenib to enhance GLP-1-based
therapies but also highlight its promise as a disease-modifying agent. Further clinical evaluation will follow, with additional insights anticipated during the J.P. Morgan Conference. Biomea will discuss its clinical plan with FDA to support these
two patient groups and move into late-stage development. The current plan includes the following two clinical trials:
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Phase 2/3 (adaptive design): icovamenib in patients with insulin deficient type 2 diabetes (HbA1c
>8.5% and BMI <32 kg/m2), uncontrolled at baseline on current antidiabetic medication |
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Phase 2b: icovamenib in combination with a
GLP-1-based therapy in patients uncontrolled on a GLP-1-based therapy at baseline and in
patients initiating a GLP-1-based therapy |
We
are excited to focus our efforts on metabolic disorders and to accelerate the development of icovamenib in 2025, said Thomas Butler, Chief Executive Officer of Biomea Fusion. Our decision reflects the significant potential we see in
addressing the insulin deficient patients and those initiating or failing on a GLP-1-based therapy. Today we have a clear understanding of where our menin inhibitor
icovamenib has the most impact and which patient population has the most potential benefit. We can easily identify those patients using HbA1c and BMI alone. Icovamenib was only dosed for 12 weeks in our study
COVALENT-111, yet we saw continued reductions in HbA1c 3 months thereafter. We look forward to seeing the 52-week data as we expect the responses to further deepen
beyond Week 26.