Biomea Fusion Showcases Preclinical Advances for BMF-650 and Icovamenib with Low Dose Semaglutide at ObesityWeek® 2025
Biomea Fusion (Nasdaq: BMEA) presented preclinical data at ObesityWeek 2025 for two candidates: BMF-650, an oral small-molecule GLP-1 receptor agonist, and icovamenib combined with low-dose semaglutide.
BMF-650 showed potent biased GLP-1 agonism, strong incretin-driven insulin release, oral bioavailability of 33% in rats and 54% in monkeys, dose-dependent glycemic improvement, and 12–15% body weight reduction in obese cynomolgus monkeys after 28 days; no aminotransferase elevations were observed. A Phase I study in healthy obese patients is enrolling with 28-day weight-loss data expected in 1H 2026.
Icovamenib plus low-dose semaglutide in ZDF rats produced superior outcomes vs semaglutide alone including ~60% lower fasting glucose, 50% lower AUC, >1% HbA1c reduction by Day 28 and >2% by Day 39, 75% lower HOMA-IR, and ~10% greater total body weight loss with lean mass preservation. Clinical evaluation of icovamenib add-on to GLP-1 therapy is planned to begin in Q4 2025 with first patient dosing expected Q1 2026.
Biomea Fusion (Nasdaq: BMEA) ha presentato dati preclinici a ObesityWeek 2025 per due candidati: BMF-650, un agonista orale di GLP-1 recettore di piccole molecole, e icovamenib combinato con semaglutide a bassa dose.
BMF-650 ha mostrato un potente agonismo GLP-1 sbilanciato, una forte stimolazione insulinica guidata dall'incretina, biodisponibilità orale del 33% nei ratti e 54% nei macachi, miglioramento glicemico dipendente dalla dose, e una perdita di peso corporeo del 12-15% nei macachi cynomolghi obesi dopo 28 giorni; non sono state osservate elevazioni delle transaminasi. Uno studio di fase I in persone obese sane è in arruolamento con dati di perdita di peso a 28 giorni attesi nel 1° semestre 2026.
ICovamenib più semaglutide a bassa dose in ratti ZDF ha prodotto esiti superiori rispetto a semaglutide da solo includendo circa il 60% in meno di glucosio a digiuno, 50% in meno di AUC, riduzione di HbA1c >1% al Giorno 28 e >2% al Giorno 39, 75% in meno di HOMA-IR, e circa 10% in più di perdita di peso totale con preservazione della massa magra. La valutazione clinica dell'aggiunta di icovamenib alla terapia GLP-1 è prevista di iniziare nel Q4 2025 con la prima somministrazione al paziente prevista nel Q1 2026.
Biomea Fusion (Nasdaq: BMEA) presentó datos preclínicos en ObesityWeek 2025 para dos candidatas: BMF-650, un agonista oral de GLP-1 receptor de molécula pequeña, y icovamenib combinado con semaglutida de dosis baja.
El BMF-650 mostró un potente agonismo GLP-1 sesgado, fuerte liberación de insulina impulsada por incretinas, biodisponibilidad oral de 33% en ratas y 54% en monos, mejora glucémica dependiente de la dosis, y una reducción de peso corporal del 12–15% en monos cynomolgus obesos después de 28 días; no se observaron elevaciones de aminotransferasas. Un estudio de fase I en pacientes obesos sanos está en reclutamiento con datos de pérdida de peso a 28 días esperados en el 1er semestre de 2026.
La combinación de icovamenib más semaglutida de dosis baja en ratas ZDF produjo resultados superiores frente a semaglutida sola, incluyendo un aprox. 60% menos glucosa en ayunas, 50% menos AUC, reducción de HbA1c >1% al Día 28 y >2% al Día 39, 75% menos HOMA-IR, y ~10% mayores pérdidas de peso total con preservación de la masa magra. La evaluación clínica de la adición de icovamenib a la terapia GLP-1 está planificada para comenzar en Q4 2025 con la primera dosis al paciente esperada Q1 2026.
Biomea Fusion (나스닥: BMEA)가 ObesityWeek 2025에서 두 후보물질에 대한 전임상 데이터를 발표했습니다: BMF-650, 경구 소분자 GLP-1 수용체 작용제, 및 icovamenib를 저용량의 세마글루타이드와 병합한 치료제.
BMF-650은 강력한 바이어스된 GLP-1 작용제, 증가인( incretin) 유도 인슐린 방출의 강력함, 쥴렛당의 경구 생체이용률(쥐에서 33%, 원숭이에서 54%), 용량 의존적인 혈당 개선 및 비만 시노몰구스(Cynomolgus) 원숭이에서 28일 후 체중 감소 12–15%를 보였으며 ALT 등 간효소 상승은 관찰되지 않았습니다. 건강한 비만 환자에서의 1상 연구가 등록 중이며 28일 체중 감소 데이터는 2026년 상반기에 기대됩니다.
ZDF 쥐에서 icovamenib과 저용량 세마글루타이드의 병용은 세마글루타이드 단독 대비 공복 혈당 약 60% 저하, AUC 50% 저하, Day 28에 HbA1c >1% 감소 및 Day 39에 >2% 감소, HOMA-IR 75% 감소, 그리고 근량 보존과 함께 총 체중 감소 약 10% 증가를 포함한 우수한 결과를 도출했습니다. GLP-1 치료에 icovamenib를 추가하는 임상 평가는 2025년 4분기에 시작될 예정이며 첫 환자 투여는 2026년 1분기에 기대됩니다.
Biomea Fusion (Nasdaq: BMEA) a présenté des données précliniques lors d'ObesityWeek 2025 pour deux candidats : BMF-650, un agoniste oral du récepteur GLP-1 à petite molécule, et icovamenib associé à une faible dose de sémaglutide.
Le BMF-650 a montré un puissant agonisme GLP-1 biaisé, une forte libération d'insuline stimulée par les incretines, une biodisponibilité orale de 33% chez les rats et 54% chez les macaques, une amélioration glycémique dépendante de la dose et une perte de poids corporelle de 12–15% chez des macaques cynomolgus obèses après 28 jours; aucune élévation des transaminases n'a été observée. Une étude de phase I chez des sujets obèses sains est en cours de recrutement avec des données de perte de poids à 28 jours attendues au 1er semestre 2026.
Icovamenib associé à une faible dose de sémaglutide chez des rats ZDF a produit des résultats supérieurs à ceux de la sémaglutide seule, notamment environ 60% de moins de glucose à jeun, 50% de moins d'AUC, une réduction de HbA1c >1% au Jour 28 et >2% au Jour 39, 75% de moins d'HOMA-IR, et environ 10% de perte de poids totale supérieure avec préservation de la masse maigre. L'évaluation clinique de l'ajout d'icovamenib au traitement GLP-1 devrait commencer au Q4 2025 avec la première dose chez le patient attendue au Q1 2026.
Biomea Fusion (Nasdaq: BMEA) präsentierte präklinische Daten auf der ObesityWeek 2025 für zwei Kandidaten: BMF-650, ein oraler Small-Molecule-GLP-1-Rezeptoragonist, und icovamenib kombiniert mit niedriger Dosis Semaglutid.
BMF-650 zeigte einen potenten bias GLP-1-Agonismus, starke incretinvermittelte Insulinfreisetzung, orale Bioverfügbarkeit von 33% bei Ratten und 54% bei Affen, dosisabhängige glykämische Verbesserungen und eine 12–15%-ige Gewichtsreduktion bei übergewichtigen Zynomolgus-Makaken nach 28 Tagen; keine transaminasebedingten Erhöhungen wurden beobachtet. Eine Phase-I-Studie bei gesunden übergewichtigen Probanden wird rekrutiert, mit 28-Tage-Gewichtsverlust-Daten erwartet im 1. Hj. 2026.
Icovamenib plus niedrige Dosis Semaglutid in ZDF-Ratten erzielte bessere Ergebnisse als Semaglutid allein, darunter ca. 60% weniger nüchternes Glukose, 50% weniger AUC, HbA1c-Rückgang >1% am Tag 28 und >2% am Tag 39, 75% weniger HOMA-IR, und ca. 10% mehr Gesamtgewichtsverlust bei Erhalt der Magermasse. Klinische Bewertung der Add-on-Therapie von Icovamenib zur GLP-1-Behandlung soll im Q4 2025 beginnen, mit der ersten Patientendosis voraussichtlich im Q1 2026.
Biomea Fusion (ناسداك: BMEA) عرضت بيانات قبل السريرية في ObesityWeek 2025 لمرشحين: BMF-650، مثبّط أحادي الجزيء لمسار GLP-1 قابل للبلع، و icovamenib مُدمَج مع سيماغلوتايد بجرعة منخفضة.
أظهر BMF-650 نشاطًا قوياً موجّهاً لـ GLP-1، إطلاقًا إنسولينياً مدفوعاً بتزايد الإنكريتين، توافر حيوي فموي بنسبة 33% في الجرذان و 54% في القرود، تحسنًا جلوكيميًا يعتمد على الجرعة، ونقصانًا في وزن الجسم بنسبة 12-15% في قرود Cynomolgus البدينة بعد 28 يومًا؛ لم تُلاحظ ارتفاعات في إنزيمات ناقلة الأمين. دراسة المرحلة I في مرضى بدناء أصحاء قيد التسجيل مع توقع بيانات فقدان الوزن خلال 28 يومًا في النصف الأول من 2026.
إضافة icovamenib مع سيماغلوتايد بجرعة منخفضة في فئران ZDF أدت إلى نتائج متفوقة مقارنة بسيماغلوتايد وحده بما في ذلك انخفاض نحو 60% في الجلوكوز الصائم، انخفاض 50% في AUC، انخفاض HbA1c >1% في اليوم 28 و>2% في اليوم 39، انخفاض 75% في HOMA-IR، و~زيادة نحو 10% في فقدان الوزن الكلي مع الحفاظ على كتلة الجسم النحيلة. من المقرر أن تبدأ التقييمات السريرية لإضافة icovamenib إلى علاج GLP-1 في الربع الرابع من 2025 مع توقع إعطاء أول جرعة للمريض في الربع الأول من 2026.
- BMF-650: 12–15% body weight reduction in monkeys (28 days)
- BMF-650 oral bioavailability 54% in monkeys
- Icovamenib+semaglutide: ~60% lower fasting glucose vs semaglutide
- Icovamenib+semaglutide: >2% HbA1c reduction by Day 39
- Preclinical results only; human efficacy unproven pending clinical data
- Icovamenib dose in rats (200 mg/kg) may not translate to humans
Insights
Preclinical PK/efficacy data look encouraging but remain preclinical; human proof still pending.
BMF-650 shows oral bioavailability and GLP-1 receptor agonism with dose-dependent glycemic improvements and
Key dependencies and risks include translatability to humans, safety beyond class effects over longer exposure, and whether the Phase I cohort replicates the weight-loss magnitude; early human data expected in
Combination preclinical data support a development path but clinical validation is required before impact is clear.
Icovamenib plus low-dose semaglutide produced superior glycemic control and roughly
Risks center on species differences, dose selection, and safety in combination with GLP-1 therapy; the most informative near-term items are the planned trial initiation in
- The Company’s investigational small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”), BMF-650, demonstrated potent weight loss and good tolerability in obese cynomolgus monkeys
- A Phase I study of BMF-650 in healthy obese patients is currently enrolling with data expected first half of 2026
- 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 preservation of lean mass, outperforming the group given low dose semaglutide alone
SAN CARLOS, Calif., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea,” “Biomea Fusion” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced the presentation of two late breaking posters at ObesityWeek® 2025 in Atlanta, Georgia.
The presentations highlighted preclinical data for BMF-650, Biomea’s investigational next-generation oral small molecule GLP-1 RA, and combination data for icovamenib, the Company’s potential best-in-class covalent menin inhibitor product candidate, with semaglutide, an injectable GLP-1 based therapy.
Presentation Summaries:
Late Breaking Poster 085
Title: Preclinical Efficacy of BMF-650, an Oral Small-Molecule GLP-1 Receptor Agonist
Study Design: BMF-650 potency, GLP-1 receptor agonism, selectivity, and mechanism of action were evaluated in a series of in vitro studies. Absorption, distribution, metabolism, and excretion (“ADME”) and pharmacokinetics were assessed in both in vitro and in vivo models. In male cynomolgus monkeys, glucose stimulated insulin secretion (“GSIS”) and glycemic control were measured following intravenous glucose administration. BMF-650-induced appetite suppression and weight loss were evaluated in a 28-day study in obese cynomolgus monkeys (n=15, five per group) receiving once-daily oral doses of 10 mg/kg, 30 mg/kg, or vehicle.
Key Findings:
- Potent and biased GLP-1 receptor agonism
- Strong incretin response with robust insulin release in intravenous glucose tolerance test studies
- Oral bioavailability of
33% in rats and54% in monkeys, exceeding that of orforglipron under matched conditions - Dose-dependent improvements in glycemia
- 12
-15% body weight reduction in obese cynomolgus monkeys after 28 days of daily oral dosing - Sustained decreases in daily food intake that paralleled weight loss outcomes
- Generally well tolerated without safety concerns outside of the observed class effects
- No aminotransferase elevations during the weight-loss study
BMF-650 is currently in a Phase I study in healthy obese patients with 28-day weight loss data expected in the first half of 2026.
Late Breaking Poster 136
Title: Icovamenib and Semaglutide Combination Enhances Weight Loss While Preserving Lean Mass in ZDF Rats
Study Design: Zucker diabetic fatty (ZDF) rats were treated with icovamenib (200 mg/kg, oral, once daily) or vehicle for 4 weeks, with low-dose semaglutide (0.02 mg/kg, subcutaneous, once daily) administered during Weeks 3 and 4. Effects on appetite, body weight and composition, and glycemic control were compared between combination treatment and low dose semaglutide alone.
Key Findings:
Combination treatment was superior to low dose semaglutide
60% lower fasting blood glucose vs semaglutide alone50% lower glucose area under the curve during oral glucose tolerance test- >
1% HbA1c reduction by Day 28 and >2% by Day 39 - Greater improvement in insulin sensitivity;
75% lower HOMA-IR - Significant enhancement of beta-cell function (C-peptide to glucose ratio)
- ~
10% greater total body weight reduction, driven by fat loss with lean mass preservation
In the fourth quarter of 2025, Biomea plans to begin clinical evaluation of icovamenib added to the treatment of T2D patients who are currently on GLP-1 based treatment and not achieving glycemic targets. The first patient is expected to be dosed in the first quarter of 2026.
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 potential 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 BMF-650
BMF-650 is an investigational, next-generation oral small-molecule GLP-1 RA being developed by Biomea Fusion for the treatment of obesity. Related to the broader orforglipron chemotype, BMF-650 is designed to combine enhanced oral bioavailability and durable receptor activation to deliver robust metabolic benefits. Biomea’s development strategy for BMF-650 focuses on achieving consistent daily target coverage from oral dosing to support a potential best-in-class profile among oral small-molecule GLP-1 therapies.
About Biomea Fusion
Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its 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 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 BMF-650, the potential of icovamenib as a treatment for T2D, the potential of BMF-650 as a treatment for obesity; our research, development and regulatory plans, the initiation, progress and availability and timing of data from our clinical trials; the mechanism of action of our product candidates and development programs 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, Investor Relations and Corporate Development
IR@biomeafusion.com
FAQ
What weight loss did BMF-650 produce in preclinical studies for BMEA?
When will BMF-650 human 28-day weight-loss data for BMEA be available?
What glycemic improvements did icovamenib plus semaglutide show in BMEA preclinical data?
Does the icovamenib data show preservation of lean mass for BMEA?
When will Biomea start clinical testing of icovamenib added to GLP-1 therapy (BMEA)?
