Biomea Fusion Reports New Preclinical Data on Icovamenib-Semaglutide Combination Study
Biomea Fusion (NASDAQ: BMEA) announced new preclinical data for the combination of icovamenib with semaglutide. The study demonstrated significant improvements compared to semaglutide alone, including an additional 11.5% body weight reduction and a 43% increase in lean muscle mass.
The combination therapy showed approximately doubled C-peptide production per unit of glucose compared to semaglutide alone, resulting in a 60% improved reduction of fasting blood glucose. Previous ex vivo human islet experiments showed icovamenib enhanced GLP-1-based therapies' activity, increasing insulin secretion.
Additionally, topline data from the COVALENT-111 study revealed that 12 weeks of daily icovamenib in patients uncontrolled on GLP-1-based therapy (n=10) achieved an HbA1c reduction of 0.84% at week 26. Further data will be presented at the upcoming J.P. Morgan Conference in January 2025.
Biomea Fusion (NASDAQ: BMEA) ha annunciato nuovi dati preclinici per la combinazione di icovamenib e semaglutide. Lo studio ha dimostrato miglioramenti significativi rispetto al semaglutide da solo, compresa una riduzione del peso corporeo del 11,5% e un aumento del 43% della massa muscolare magra.
La terapia combinata ha mostrato una produzione di C-peptide per unità di glucosio circa raddoppiata rispetto al solo semaglutide, risultando in una riduzione migliorata del 60% della glicemia a digiuno. Esperimenti precedenti ex vivo su isole umane hanno mostrato che l'icovamenib potenzia l'attività delle terapie basate su GLP-1, aumentando la secrezione di insulina.
Inoltre, i dati preliminari dello studio COVALENT-111 hanno rivelato che 12 settimane di icovamenib quotidiano in pazienti non controllati con terapia basata su GLP-1 (n=10) hanno ottenuto una riduzione dell'HbA1c dello 0,84% alla settimana 26. Ulteriori dati saranno presentati alla prossima Conferenza J.P. Morgan a gennaio 2025.
Biomea Fusion (NASDAQ: BMEA) anunció nuevos datos preclínicos sobre la combinación de icovamenib con semaglutida. El estudio demostró mejoras significativas en comparación con la semaglutida sola, incluyendo una reducción del 11,5% del peso corporal y un incremento del 43% en la masa muscular magra.
La terapia combinada mostró aproximadamente el doble de producción de C-peptido por unidad de glucosa en comparación con la semaglutida sola, lo que resultó en una mejora del 60% en la reducción de la glucosa en sangre en ayunas. Experimentos previos ex vivo en islotes humanos mostraron que el icovamenib potenció la actividad de las terapias basadas en GLP-1, aumentando la secreción de insulina.
Además, los datos iniciales del estudio COVALENT-111 revelaron que 12 semanas de icovamenib diario en pacientes no controlados en terapia basada en GLP-1 (n=10) lograron una reducción del HbA1c del 0,84% en la semana 26. Se presentarán más datos en la próxima Conferencia J.P. Morgan en enero de 2025.
Biomea Fusion (NASDAQ: BMEA)는 icovamenib과 semaglutide의 조합에 대한 새로운 전임상 데이터를 발표했습니다. 이 연구는 semaglutide 단독에 비해 상당한 개선 사항을 보여주었으며, 체중 11.5% 감소와 제지방 근육량 43% 증가를 포함했습니다.
조합 요법은 semaglutide 단독에 비해 단위당 C-펩타이드 생산이 약 두 배로 늘어났으며, 금식 혈당이 60% 개선된 결과를 가져왔습니다. 이전의 ex vivo 인간 섬 연구에서는 icovamenib이 GLP-1 기반 요법의 효능을 강화하여 인슐린 분비를 증가시킨 것으로 나타났습니다.
또한, COVALENT-111 연구의 초기 데이터에 따르면, GLP-1 기반 요법으로 조절되지 않는 환자(n=10)에서 12주간 매일 icovamenib을 투여한 결과, 26주 차에 HbA1c가 0.84% 감소했습니다. 추가 데이터는 2025년 1월에 개최될 J.P. Morgan Conference에서 발표될 예정입니다.
Biomea Fusion (NASDAQ: BMEA) a annoncé de nouvelles données précliniques concernant la combinaison d'icovamenib avec la sémaglutide. L'étude a montré des améliorations significatives par rapport à la sémaglutide seule, notamment une réduction de poids de 11,5% et une augmentation de 43% de la masse musculaire maigre.
La thérapie combinée a montré une production de C-peptide par unité de glucose presque doublée par rapport à la sémaglutide seule, entraînant une amélioration de 60% de la réduction de la glycémie à jeun. Des expériences ex vivo précédentes sur des îlots humains ont montré que l'icovamenib renforçait l'activité des thérapies basées sur le GLP-1, augmentant ainsi la sécrétion d'insuline.
De plus, les données initiales de l'
Biomea Fusion (NASDAQ: BMEA) hat neue präklinische Daten zur Kombination von Icovamenib und Semaglutid bekannt gegeben. Die Studie zeigte signifikante Verbesserungen im Vergleich zu Semaglutid allein, einschließlich einer Gewichtsreduktion von 11,5% und einer 43%igen Zunahme der fettfreien Muskelmasse.
Die Kombinationstherapie zeigte eine etwa doppelte C-Peptid-Produktion pro Glukoseeinheit im Vergleich zu Semaglutid allein, was zu einer 60%igen Verbesserung der Nüchternblutzuckerreduktion führte. Frühere ex vivo-Studien an menschlichen Inseln zeigten, dass Icovamenib die Aktivität von GLP-1-basierten Therapien verstärkt und die Insulinsekretion erhöht.
Zusätzlich ergaben die vorläufigen Daten aus der COVALENT-111-Studie, dass 12 Wochen täglicher Einnahme von Icovamenib bei Patienten, die nicht auf GLP-1-basierte Therapien ansprechen (n=10), eine HbA1c-Reduktion von 0,84% in der Woche 26 erreichten. Weitere Daten werden auf der kommenden J.P. Morgan-Konferenz im Januar 2025 vorgestellt.
- Combination therapy showed 11.5% additional body weight reduction vs semaglutide alone
- 43% increase in lean muscle mass compared to semaglutide monotherapy
- 60% improved reduction in fasting blood glucose
- 0.84% HbA1c reduction at week 26 in COVALENT-111 study
- Doubled C-peptide production per unit of glucose
- Small patient sample size (n=10) in COVALENT-111 study
Insights
The new preclinical data for icovamenib-semaglutide combination represents a potential breakthrough in metabolic disease treatment. The 11.5% additional body weight reduction and 43% increase in lean muscle mass compared to semaglutide alone are remarkable metrics that address two critical aspects of metabolic health. The preservation and increase of lean muscle mass while losing weight is particularly noteworthy, as this has been a persistent challenge in obesity treatments.
The doubled C-peptide production and 60% improved reduction in fasting blood glucose indicate enhanced insulin secretion and glucose control. These results, combined with the 0.84% HbA1c reduction in patients uncontrolled on GLP-1 therapy, suggest icovamenib could potentially overcome GLP-1 resistance, a growing concern in diabetes management.
This data positions Biomea Fusion strategically in the rapidly growing GLP-1 market, currently dominated by companies like Novo Nordisk and Eli Lilly. The combination approach could represent a significant market opportunity, particularly for patients who show incomplete response to GLP-1s alone. With the global GLP-1 market projected to reach <money>200 billion</money> by 2030, even capturing a small segment could translate to substantial revenue potential.
The timing of this announcement ahead of the J.P. Morgan Healthcare Conference is strategic, as this event typically catalyzes biotechnology sector movement. For a company with a market cap of <money>141 million</money>, these results could attract partnership interest from larger pharmaceutical companies looking to enhance their diabetes/obesity portfolios.
- New in vivo preclinical data announced today, demonstrate that icovamenib, in combination with semaglutide showed additional
11.5% body weight reduction and43% increase in lean muscle mass compared to semaglutide alone - Icovamenib, in combination with semaglutide, approximately doubled C-peptide production per unit of glucose compared to semaglutide alone leading to a
60% improved reduction of fasting blood glucose - Ex vivo human islet experiments previously presented in October, showed that icovamenib enhanced the activity of glucagon-like peptide-1 (GLP-1)-based therapies, leading to substantial increase in insulin secretion
- Topline data from the COVALENT-111 study showed that 12 weeks of daily icovamenib in patients uncontrolled on a GLP-1-based therapy (n=10) led to an HbA1c reduction of
0.84% at week 26 - Further data will be presented during the upcoming J.P. Morgan Conference January 13-15, 2025
REDWOOD CITY, Calif., Jan. 07, 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 with diabetes, obesity, and genetically defined cancers, today announce compelling results from in vivo studies of icovamenib in combination with semaglutide.
About the study:
This preclinical study evaluated the efficacy of icovamenib, an investigational covalent menin inhibitor, in combination with a GLP-1 receptor agonist (i.e., semaglutide) to assess key metabolic parameters in animal models including: improvements in C-peptide index, a marker of insulin secretion and glucose regulation, blood glucose, HbA1c, insulin resistance (HOMA-IR) and beta cell function (HOMA-B), changes in body weight and composition, including fat and lean mass, and appetite suppression. Biomarkers were analyzed at multiple time points throughout a 28-day period. The study was conducted in two groups, one group of 10 Zucker Diabetic Fatty (ZDF) rats dosed with icovamenib (day 1 through day 28) in combination with semaglutide (day 14 through day 28) and a second group of 10 ZDF rats dosed with semaglutide alone (day 14 through day 28). ZDF rat is a type 2 diabetes animal model of insulin resistance.
Highlights of the Study:
Superior Glycemic Control:
- A
60% reduction in fasting blood glucose level was observed with combination therapy compared to semaglutide alone. - A
50% reduction in area under the curve (AUC) was observed during the Oral Glucose Tolerance Test (OGTT) with combination therapy versus semaglutide alone, indicating improved glucose metabolism (p<0.0001).
Improvements in HbA1c:
- HbA1c reduction on Day 28 was greater with the combination therapy (>
1% ) compared to semaglutide alone (p<0.05).
Reduced Insulin Resistance and Improvements in Beta Cell Function:
- Insulin resistance as measured by HOMA-IR was reduced by
75% with combination therapy compared to semaglutide alone (p<0.001). - Combination treatment also improved beta-cell function as measured by HOMA-B.
Weight Loss and Muscle Mass Improvements:
- Combination therapy reduced body weight by
11.5% and fat mass by29.5% compared to semaglutide alone. - A
43% increase in lean mass compared to semaglutide alone was also observed with combination therapy. - We believe these results underscore the combination's unique ability to reduce fat mass while preserving and enhancing lean muscle mass.
Validated Safety
- Icovamenib in combination with semaglutide was well tolerated across multiple time points.
“We believe these preclinical results underscore the potential of icovamenib to transform diabetes treatment when combined with GLP-1-based therapies,” said Juan Pablo Frias, Biomea Fusion’s Chief Medical Officer. “Our studies demonstrated that icovamenib not only increased the C-peptide index but also amplified key benefits of GLP-1 therapies, including improved glycemic and body weight control. Importantly, this synergy may enable lower doses of GLP-1 therapies to achieve glycemic and weight loss targets, potentially reducing side effects and improving tolerability. We are very encouraged by these preclinical results and look forward to further assessing this combination in clinical trials to potentially address unmet needs of people living with type 2 diabetes.”
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 (T1D) (mediated by autoimmune dysfunction) and type 2 diabetes (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 potentially halt or reverse progression of T2D.
About Type 2 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 37 million people of all ages (about
About Icovamenib
Icovamenib is an investigational, orally bioavailable, potent, and selective covalent inhibitor of menin. The molecule was built using Biomea Fusion’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.
About Biomea Fusion
Biomea Fusion is a clinical-stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response.
We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small-molecule medicines designed to maximize clinical benefit for patients. We aim to have an outsized impact on the treatment of disease for the patients we serve. 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, their mechanism of action, and their potential relative to approved products marketed by third parties; the potential benefits to future trial design and program development of subtyping diabetes patients and their potential to be used in combination with approved products marketed by third parties; our research, development and regulatory plans, the progress of our ongoing and upcoming clinical trials 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:
Ramses Erdtmann
COO & President of Biomea Fusion
re@biomeafusion.com
FAQ
What were the key results of Biomea Fusion's (BMEA) icovamenib-semaglutide combination study?
What HbA1c reduction did BMEA's COVALENT-111 study achieve at week 26?
How did icovamenib affect C-peptide production when combined with semaglutide?
When will Biomea Fusion (BMEA) present additional icovamenib data?
