Biomea Fusion Announces First Patient Dosed in Phase I Study of BMF-650 a Next-Generation Oral GLP-1 Receptor Agonist
Biomea Fusion (Nasdaq: BMEA) announced the first patient has been dosed in a Phase I trial of BMF-650, an oral small-molecule GLP-1 receptor agonist for obesity. Preclinical primate studies showed dose-dependent weight loss: ~12% at 10 mg/kg and ~15% at 30 mg/kg over 28 days, with appetite suppression and a favorable safety profile. The Phase I study will evaluate safety, tolerability and preliminary efficacy in overweight or obese participants, with 28-day weight-loss data at the highest dose expected in the first half of 2026.
Biomea Fusion (Nasdaq: BMEA) ha annunciato che il primo paziente è stato dosato in uno studio di Fase I di BMF-650, un agonista GLP-1 recettoriale orale per l'obesità. Studi preclinici sui primati hanno mostrato una perdita di peso dipendente dalla dose: circa 12% a 10 mg/kg e circa 15% a 30 mg/kg in 28 giorni, con soppressione dell'appetito e un profilo di sicurezza favorevole. Lo studio di Fase I valuterà sicurezza, tollerabilità ed efficacia preliminare in partecipanti in sovrappeso o obesi, con dati di perdita di peso a 28 giorni alla dose più alta attesi nella prima metà del 2026.
Biomea Fusion (Nasdaq: BMEA) anunció que ya se administró la primera dosis al primer paciente en un ensayo de Fase I de BMF-650, un agonista oral de GLP-1 para la obesidad. Los estudios preclínicos en primates mostraron pérdida de peso dependiente de la dosis: ~12% a 10 mg/kg y ~15% a 30 mg/kg durante 28 días, con supresión del apetito y un perfil de seguridad favorable. El estudio de Fase I evaluará seguridad, tolerabilidad y eficacia preliminar en participantes con sobrepeso u obesos, con datos de pérdida de peso a 28 días para la dosis más alta esperados en la primera mitad de 2026.
Biomea Fusion (나스닥: BMEA)은 BMF-650의 1상 임상에서 첫 환자에게 투여가 이루어졌다고 발표했다, 비만 치료를 위한 경구용 소분자 GLP-1 수용체 작용제이다. 전임상 영장류 연구에서 용량 의존적인 체중 감소를 보였으며: 28일 동안 10 mg/kg에서 약 12%, 30 mg/kg에서 약 15%, 식욕 억제와 우수한 안전성 프로필이 동반되었다. 1상 연구는 과체중 또는 비만 참가자에서 안전성, 내약성 및 예비 효능을 평가할 것이며, 최고 용량에서의 28일 체중 감소 데이터는 2026년 상반기에 기대된다.
Biomea Fusion (Nasdaq : BMEA) a annoncé que le premier patient a été dosé dans un essai de Phase I de BMF-650, un agoniste oral de petite molécule du récepteur GLP-1 pour l'obésité. Des études précliniques chez les primates ont montré une perte de poids dépendante de la dose : environ 12% à 10 mg/kg et environ 15% à 30 mg/kg sur 28 jours, avec une suppression de l'appétit et un profil de sécurité favorable. L'étude de Phase I évaluera la sécurité, la tolérance et l'efficacité préliminaire chez des participants en surpoids ou obèses, avec des données de perte de poids sur 28 jours à la dose la plus élevée attendues dans la première moitié de 2026.
Biomea Fusion (Nasdaq: BMEA) kündigte an, dass der erste Patient in einer Phase-I-Studie von BMF-650, einem oralen Small-Molecule-GLP-1-Rezeptor-Agonisten für Fettleibigkeit, dosiert wurde. Präklinische Primatenstudien zeigten eine dosisabhängige Gewichtsabnahme: ca. 12% bei 10 mg/kg und ca. 15% bei 30 mg/kg über 28 Tage, mit Appetitzügelung und einem günstigen Sicherheitsprofil. Die Phase-I-Studie wird Sicherheit, Verträglichkeit und vorläufige Wirksamkeit bei übergewichtigen oder fettleibigen Teilnehmern bewerten, mit 28-Tage-Gewichtsverlustdaten bei der höchsten Dosis, voraussichtlich in der ersten Hälfte des Jahres 2026.
Biomea Fusion (ناسداك: BMEA) أعلنت أن أول مريض قد جرى إعطاؤه جرعة في تجربة المرحلة الأولى لـ BMF-650، وهو مُنشّط GLP-1 فموي لعلاج السمنة. أظهرت الدراسات قبل السريرية على القرود فقدان وزن يعتمد على الجرعة: نحو 12% عند 10 mg/kg ونحو 15% عند 30 mg/kg على مدى 28 يوماً، مع كبت للشهية وملف أمان جيد. ستقيِّم تجربة المرحلة الأولى السلامة والتحمّل والفعالية الأولية لدى المشاركين ذوي الوزن الزائد أو المصابين بالسمنة، مع بيانات فقدان الوزن خلال 28 يوماً عند أعلى جرعة متوقعة في النصف الأول من 2026.
Biomea Fusion (纳斯达克：BMEA)宣布，BMF-650的一项Phase I研究的首位患者已接受给药，这是一种用于肥胖的口服小分子 GLP-1 受体激动剂。
在28天内，临床前灵长类动物研究显示剂量相关的体重减轻：10 mg/kg 时约减重 12%，30 mg/kg 时约减重 15%，伴随食欲抑制和良好的安全性特征。
I 期研究将评估超重或肥胖受试者的安全性、耐受性及初步有效性，在高剂量下的28天减重数据预计在 2026 年上半年公布。
- First patient dosed in Phase I study
- Preclinical weight loss of ~12% at 10 mg/kg in primates
- Preclinical weight loss of ~15% at 30 mg/kg in primates
- Initial human data expected H1 2026
- Preclinical efficacy reported only in cynomolgus monkeys
- Phase I study limited to 28-day weight-loss data at highest dose
Insights
First‑patient dosing starts clinical testing for an oral GLP‑1 candidate; initial 28‑day data expected in
Biomea advanced BMF-650 into a Phase I study that will measure safety, tolerability, and preliminary efficacy in overweight or obese adults. The protocol includes 28‑day weight assessments at the highest dose, which creates an early, concrete efficacy readout.
Key dependencies include clinical safety in humans and whether the drug reproduces preclinical
Preclinical primate results were robust; Phase I will test if improved oral PK and potency translate to humans.
BMF-650 is described as a next‑generation oral small molecule GLP‑1 receptor agonist with improved oral bioavailability and reduced PK variability versus its chemotype peers. The primate study reported dose‑dependent appetite suppression and weight loss over a 28‑day course, with ~
Translatability is the main risk; human PK, protein binding effects, and tolerability will determine clinical value. Monitor single‑ and multiple‑ascending dose PK, exposure‑response for weight and appetite, and any safety signals in the first 28‑day highest‑dose cohort expected in
Initial Clinical Data Expected in the First Half of 2026
SAN CARLOS, Calif., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea,” “Biomea Fusion” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that the first patient has been dosed in a Phase I clinical trial of BMF-650, the Company’s investigational, next-generation oral small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”).
BMF-650 is an orally administered, next-generation small molecule GLP-1 RA being developed by Biomea for the treatment of obesity. Structurally related to the chemotype class of orforglipron, BMF-650 was designed to combine enhanced oral bioavailability with less PK variability and high plasma protein binding with good intrinsic potency to achieve more patient-friendly weight reduction outcomes.
In preclinical studies with obese cynomolgus monkeys, once-daily oral administration of BMF-650 (10 mg/kg and 30 mg/kg) resulted in clear, dose-dependent reductions in daily food intake and continuous, progressive weight loss over a 28-day treatment period. Animals receiving 10 mg/kg and 30 mg/kg doses achieved average body weight reductions of approximately
“Dosing the first patient represents a major milestone for the BMF-650 program and the dedicated team behind it,” said Thorsten Kirschberg, Ph.D., Executive Vice President of Research at Biomea Fusion and program lead for BMF-650. “We are very pleased to advance BMF-650 into clinical evaluation, building on the compelling preclinical results in primates that demonstrated robust appetite suppression, weight loss, and glucose-lowering benefits. With its enhanced pharmacokinetic profile, including improved oral bioavailability and consistent plasma exposure, we believe BMF-650 has the potential to deliver distinct metabolic benefits in a convenient, once-daily oral form. We look forward to sharing initial data from this study, which is anticipated to be announced in the first half of 2026.”
The Phase I clinical trial will assess the safety, tolerability, and preliminary efficacy of BMF-650 in otherwise healthy overweight or obese participants, with 28-day weight loss data at the highest dose expected in the first half of 2026.
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.
In preclinical studies, BMF-650 demonstrated a favorable pharmacokinetic profile with higher bioavailability, good efficacy, and less inter-individual variability compared to published third-party preclinical data on another oral GLP-1 RA. These attributes may support improved tolerability and more effective dose escalation in clinical settings. BMF-650 significantly enhanced glucose-stimulated insulin secretion in both human donor islets and in vivo in non-human primates and showed robust glucose-lowering activity and appetite suppression in cynomolgus monkey models. Notably, daily oral dosing resulted in dose-dependent reductions in food intake and progressive weight loss across the treatment period in a study with obese cynomolgus monkeys.
Biomea’s development strategy for BMF-650 focuses on achieving consistent plasma levels and increased drug exposure to support a potential best-in-class profile among oral small-molecule GLP-1 therapies.
About Obesity
Obesity is a chronic disease necessitating long-term management, associated with diminished life expectancy and a spectrum of severe health complications. These include metabolic disorders such as type 2 diabetes and metabolic liver disease; cardiovascular diseases such as coronary artery disease, cerebrovascular disease, and hypertension; and increased risks of chronic kidney disease, certain cancers, and chronic inflammation. The Centers for Disease Control and Prevention estimates that over
About GLP-1 Receptor Agonists
GLP-1 is a naturally occurring incretin hormone that plays a vital role in glucose homeostasis and appetite regulation. GLP-1 RAs are a class of medications that bind to and activate GLP-1 receptors, mimicking the effects of native GLP-1. These agents have demonstrated robust clinical efficacy in improving glycemic control, promoting weight loss, and enhancing insulin sensitivity in individuals with type 2 diabetes and obesity.
About Biomea Fusion
Biomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecule product candidates, icovamenib and BMF-650, both designed to significantly improve the lives of patients with diabetes, obesity, and metabolic diseases. 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-650, the potential of BMF-650 as a treatment for type 2 diabetes and obesity, and our expectations regarding the optimal dose and target patient population; our research, development, partnership and regulatory plans, the mechanism of action of our product candidates and development programs; the progress and initiation of our ongoing and upcoming clinical trials, including our Phase I study for BMF-650, the anticipated availability of data from our clinical trials; our planned interactions with regulators 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 results of preclinical studies may not be predictive of future preclinical results or clinical results in connection with planned clinical trials and the risk that we may encounter delays in preclinical or clinical development, interactions with regulatory authorities related to clinical development, and in the initiation, conduct and completion of our planned clinical trials and other research and development activities. These risks concerning Biomea’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
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