Biomea Fusion to Unveil New Icovamenib Data at the 18th International Conference on Advanced Technologies & Treatments for Diabetes
Biomea Fusion (BMEA) will present new clinical data for its diabetes drug icovamenib at the 18th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2025) in Amsterdam, March 19-22, 2025.
The company will deliver two oral presentations, one poster presentation, and chair a symposium, featuring new findings from the COVALENT-111 study's Expansion Phase. The data demonstrates icovamenib's potential in enhancing beta cell function and providing sustained glycemic control in type 2 diabetes patients, with effects lasting 14 weeks post-treatment.
Previous results showed significant HbA1c reductions after 12 weeks of treatment in patients with insulin-deficient type 2 diabetes uncontrolled on standard therapies. The presentations will include new c-peptide data and preclinical results combining icovamenib with GLP-1 receptor agonists, positioning it as a potential first-in-class, disease-modifying therapy for severe insulin-deficient type 2 diabetes, which affects over 100 million adults worldwide.
Biomea Fusion (BMEA) presenterà nuovi dati clinici per il suo farmaco per il diabete icovamenib durante la 18ª Conferenza Internazionale sulle Tecnologie Avanzate e i Trattamenti per il Diabete (ATTD 2025) ad Amsterdam, dal 19 al 22 marzo 2025.
L'azienda effettuerà due presentazioni orali, una presentazione poster e presiederà un simposio, presentando nuove scoperte dalla Fase di Espansione dello studio COVALENT-111. I dati dimostrano il potenziale di icovamenib nell'ottimizzare la funzione delle cellule beta e nel fornire un controllo glicemico sostenuto nei pazienti con diabete di tipo 2, con effetti che durano 14 settimane dopo il trattamento.
I risultati precedenti hanno mostrato significative riduzioni dell'HbA1c dopo 12 settimane di trattamento in pazienti con diabete di tipo 2 insulinodipendente non controllato con terapie standard. Le presentazioni includeranno nuovi dati sui c-peptidi e risultati preclinici che combinano icovamenib con agonisti del recettore GLP-1, posizionandolo come una potenziale terapia innovativa e modificante la malattia per il diabete di tipo 2 grave insulinodipendente, che colpisce oltre 100 milioni di adulti in tutto il mondo.
Biomea Fusion (BMEA) presentará nuevos datos clínicos para su medicamento contra la diabetes icovamenib en la 18ª Conferencia Internacional sobre Tecnologías Avanzadas y Tratamientos para la Diabetes (ATTD 2025) en Ámsterdam, del 19 al 22 de marzo de 2025.
La compañía realizará dos presentaciones orales, una presentación de póster y presidirá un simposio, presentando nuevos hallazgos de la Fase de Expansión del estudio COVALENT-111. Los datos demuestran el potencial de icovamenib en mejorar la función de las células beta y proporcionar un control glucémico sostenido en pacientes con diabetes tipo 2, con efectos que duran 14 semanas después del tratamiento.
Resultados anteriores mostraron reducciones significativas de HbA1c después de 12 semanas de tratamiento en pacientes con diabetes tipo 2 insulinodeficiente no controlada con terapias estándar. Las presentaciones incluirán nuevos datos de c-péptido y resultados preclínicos que combinan icovamenib con agonistas del receptor GLP-1, posicionándolo como una terapia potencial innovadora y modificadora de la enfermedad para la diabetes tipo 2 severa insulinodeficiente, que afecta a más de 100 millones de adultos en todo el mundo.
Biomea Fusion (BMEA)는 2025년 3월 19일부터 22일까지 암스테르담에서 열리는 제18회 국제 고급 기술 및 당뇨병 치료 회의(ATTD 2025)에서 당뇨병 약물 아이코바메닙에 대한 새로운 임상 데이터를 발표할 예정입니다.
회사는 두 개의 구두 발표와 하나의 포스터 발표를 진행하며, COVALENT-111 연구의 확장 단계에서의 새로운 발견을 다루는 심포지엄을 주재할 것입니다. 데이터는 아이코바메닙이 베타 세포 기능을 향상시키고 2형 당뇨병 환자에서 지속적인 혈당 조절을 제공하는 잠재력을 가지고 있음을 보여줍니다, 치료 후 14주 동안 효과가 지속됩니다.
이전 결과는 표준 요법으로 조절되지 않는 인슐린 결핍 2형 당뇨병 환자에서 12주 치료 후 HbA1c 수치가 유의미하게 감소했음을 보여주었습니다. 발표에는 c-펩타이드에 대한 새로운 데이터와 GLP-1 수용체 작용제와 아이코바메닙을 결합한 전임상 결과가 포함되어 있으며, 이는 심각한 인슐린 결핍 2형 당뇨병에 대한 질병 수정 치료제로서의 잠재력을 갖추고 있습니다. 이 질병은 전 세계 1억 명 이상의 성인에게 영향을 미칩니다.
Biomea Fusion (BMEA) présentera de nouvelles données cliniques concernant son médicament contre le diabète, l'icovamenib, lors de la 18ème Conférence Internationale sur les Technologies Avancées et les Traitements du Diabète (ATTD 2025) à Amsterdam, du 19 au 22 mars 2025.
L'entreprise fera deux présentations orales, une présentation par affiche et présidera un symposium, présentant de nouvelles découvertes de la phase d'expansion de l'étude COVALENT-111. Les données démontrent le potentiel de l'icovamenib à améliorer la fonction des cellules bêta et à fournir un contrôle glycémique soutenu chez les patients atteints de diabète de type 2, avec des effets qui durent 14 semaines après le traitement.
Les résultats précédents ont montré des réductions significatives de l'HbA1c après 12 semaines de traitement chez des patients atteints de diabète de type 2 insulinodépendant non contrôlé par les thérapies standard. Les présentations incluront de nouvelles données sur le c-peptide et des résultats précliniques combinant l'icovamenib avec des agonistes du récepteur GLP-1, le positionnant comme une thérapie potentiellement novatrice et modifiant la maladie pour le diabète de type 2 sévère insulinodépendant, qui touche plus de 100 millions d'adultes dans le monde.
Biomea Fusion (BMEA) wird auf der 18. Internationalen Konferenz über fortschrittliche Technologien und Behandlungen für Diabetes (ATTD 2025) in Amsterdam vom 19. bis 22. März 2025 neue klinische Daten für sein Diabetesmedikament Icovamenib präsentieren.
Das Unternehmen wird zwei mündliche Präsentationen, eine Posterpräsentation durchführen und ein Symposium leiten, das neue Erkenntnisse aus der Expansionsphase der COVALENT-111-Studie präsentiert. Die Daten zeigen das Potenzial von Icovamenib, die Beta-Zell-Funktion zu verbessern und eine nachhaltige glykämische Kontrolle bei Patienten mit Typ-2-Diabetes zu bieten, wobei die Wirkungen 14 Wochen nach der Behandlung anhalten.
Frühere Ergebnisse zeigten signifikante HbA1c-Reduktionen nach 12 Wochen Behandlung bei Patienten mit insulinmangelndem Typ-2-Diabetes, die mit Standardtherapien nicht kontrolliert werden konnten. Die Präsentationen werden neue C-Peptid-Daten und präklinische Ergebnisse enthalten, die Icovamenib mit GLP-1-Rezeptor-Agonisten kombinieren und es als potenzielle neuartige, krankheitsmodifizierende Therapie für schweren insulinmangelnden Typ-2-Diabetes positionieren, der über 100 Millionen Erwachsene weltweit betrifft.
- Sustained glycemic control effects lasting 14 weeks post-treatment
- Significant HbA1c reductions in insulin-deficient T2D patients
- Large market opportunity with 100M+ affected patients globally
- Potential first-in-class disease-modifying therapy status
- None.
Presentation to highlight new clinical data from COVALENT-111, including c-peptide data
REDWOOD CITY, Calif., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that it will feature two oral presentations, one poster presentation, and chair a symposium at the 18th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2025). The conference will be held in Amsterdam, Netherlands, from March 19-22, 2025 and serves as a premier international forum showcasing cutting-edge advancements in diabetes care among clinicians, researchers, industry leaders, and policymakers.
Biomea’s presentations at ATTD 2025 will showcase preclinical data evaluating the combination of icovamenib with GLP-1 receptor agonists, as well as new clinical findings from the Expansion Phase of the COVALENT-111 study. These data further support the potential of covalent menin inhibition to enhance beta cell function and provide sustained improvements in glycemic control for patients with type 2 diabetes (“T2D”), even 14 weeks after cessation of the icovamenib treatment. Additionally, new insights into beta cell function and c-peptide secretion will be presented, offering deeper understanding of icovamenib’s potential to restore endogenous insulin production in people with T2D.
Previous findings have demonstrated that 12 weeks of icovamenib treatment resulted in statistically significant HbA1c reductions among study participants with insulin deficient T2D who were uncontrolled on standard-of-care therapies. Severe insulin deficient T2D remains one of the most critical unmet medical needs, affecting more than 100 million adults worldwide. The ATTD 2025 presentations will further elucidate icovamenib’s mechanism of action, reinforcing its potential as a first-in-class, disease modifying therapy.
Presentation details:
Oral Presentation Abstract #1184
Title: COVALENT-111: Exploring Icovamenib in Persons with Poorly Controlled Severe Insulin-Deficient (SIDD) Type 2 Diabetes
Presentation Date and Time: March 20, 2025, at 10:00am CET
Oral Presentation Abstract #1339
Title: Combination of Icovamenib and GLP-1 Based Therapeutic Agents Improves Beta Cell Function and Insulin Secretion
Presentation Date and Time: March 20, 2025, at 4:10pm CET
Poster Presentation Abstract #0953
Title: COVALENT-111: Evaluating Long-Term Efficacy and Safety of Short-Term Icovamenib Treatment in Persons with Type 2 Diabetes
Presentation Date and Time: March 21, 2025, at 10:35am CET
Symposium
Title: Harnessing Menin Inhibition: Exploring Icovamenib as a Potential First-in-Class Medicine for Precision Diabetes Care
Location, Date and Time: Hall B March 22, 2025, at 8:30am CET
All abstracts will be published in the peer-reviewed Journal of Diabetes Technology & Therapeutics. Biomea will release further details in accordance with ATTD’s abstract embargo policies.
Biomea remains committed to advancing novel therapies that enhance patient outcomes in diabetes and obesity. For more information, please visit our website or contact our investor relation team.
About Menin’s Role in Diabetes
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 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’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.
About Biomea Fusion
Biomea is a clinical-stage diabetes and obesity medicines company focused on the discovery and development of oral covalent small molecules to improve the lives of patients with diabetes, obesity, and metabolic disease. 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, including BMF-219, the potential of BMF-219 as a treatment for T1D and T2D, our research, development and regulatory plans, the progress of our ongoing and planned clinical trials, including COVALENT-111, the availability of data from our 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.
Contact:
Meichiel Jennifer Weiss
Sr. Director, Investor Relations and Corporate Development
IR@biomeafusion.com
FAQ
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