BMF-650 / Biomea Fusion - LARVOL DELTA

Preclinical Efficacy of BMF-650 An Oral Small Molecule GLP-1 Receptor Agonist (OBESITY WEEK 2025) - "BMF-650 is a potent, biased agonist of the human GLP-1R. In-vivo, BMF-650 induced efficient GSIS and glucose reduction in cynomolgus monkeys. In a weight loss study in obese monkeys, BMF-650 was well tolerated and showed significant and dose dependent weight reduction of 12% and 15% at the end of the 28 days oral dosing period."

Preclinical • Genetic Disorders • Obesity

Title: Preclinical Efficacy of BMF-650, an Oral Small-Molecule GLP-1 Receptor Agonist (GlobeNewswire) - "Biomea Fusion Showcases Preclinical Advances for BMF-650...at ObesityWeek 2025....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 and 54% in monkeys, exceeding that of orforglipron under matched conditions....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."

P1 data • Preclinical • Obesity

Biomea Fusion to Present Poster Presentations at ObesityWeek 2025 (GlobeNewswire) - "The presentations will highlight preclinical data for BMF-650, Biomea’s next-generation oral small molecule glucagon-like peptide-1 ('GLP-1') receptor agonist ('RA'), and combination data for icovamenib, the company’s first-in-class covalent menin inhibitor, with semaglutide, a GLP-1 based therapy."

Preclinical • Obesity

Study of BMF-650 in Otherwise Healthy Overweight or Obese Adult Participants (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Biomea Fusion Inc.

New P1 trial • Genetic Disorders • Obesity

Biomea Fusion Announces First Patient Dosed in Phase I Study of BMF-650 a Next-Generation Oral GLP-1 Receptor Agonist (GlobeNewswire) - "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."

P1 data • Trial status • Obesity

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. (GlobeNewswire) - "Animals receiving 10 mg/kg and 30 mg/kg doses achieved average body weight reductions of approximately 12% and 15%, respectively, from baseline."

Preclinical • Obesity

…Biomea also announced progress of its BMF-650 program (GlobeNewswire) - "Initiation of a Phase I clinical trial in obesity is on track with 28-day weight loss data expected in the first half 2026."

New P1 trial • Obesity

Biomea Fusion Reports Second Quarter 2025 Financial Results and Corporate Highlights (GlobeNewswire) - "Key Anticipated 2025 Milestones:...BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity): (i) Submission of the IND application for BMF-650 is planned for the second half of 2025; (ii) Phase I study initiation in obese, otherwise healthy volunteers anticipated by late 2025, pending regulatory clearance."

IND • New P1 trial • Obesity

Biomea Fusion Reports Preclinical Data for BMF-650, a Next-Generation Oral GLP-1 Receptor Agonist Candidate, Demonstrating Robust Weight Loss and Appetite Suppression in Obese Non-Human Primates (GlobeNewswire) - "Biomea Fusion...announced new preclinical findings from a 28-day weight loss study in obese non-human primates evaluating BMF-650....The study demonstrated a clear, dose-dependent reduction in daily food intake and pronounced and continuous weight loss over a 28-day treatment period. BMF-650 was administered orally once daily at 10 mg/kg and 30 mg/kg and resulted in marked reductions in food intake and progressive body weight reductions, with the respective dose groups achieving a 12% and 15% average weight reduction from baseline over 28 days....A full set of preclinical data for BMF-650 is planned for submission and presentation at an upcoming medical conference....IND filing on track for the second half of 2025; with Phase I study initiation in obese, otherwise healthy volunteers anticipated late 2025."

IND • New P1 trial • Preclinical • Obesity

Biomea Fusion Reports First Quarter 2025 Financial Results and Corporate Highlights (GlobeNewswire) - "Key Anticipated 2025 Milestones:...BMF-650 (Next-generation Oral Small Molecule GLP-1 Receptor Agonist for Obesity): Submission of the Investigational New Drug ('IND') application for BMF-650 planned for the second half of 2025."

IND • Obesity

Biomea Fusion…Introduces BMF-650, a Next-Generation, Oral Small-Molecule GLP-1 Receptor Agonist Candidate (GlobeNewswire) - "We conducted preclinical studies to evaluate the properties of BMF-650 in comparison to a leading oral GLP-1 RA. BMF-650 exhibited higher bioavailability and a less variable pharmacokinetic profile, which may translate to improved tolerability and support successful dose escalation in patients. The estimated human dose will be approximately 100 mg once daily; In human donor islet studies, BMF-650 significantly enhanced glucose-stimulated insulin secretion. In cynomolgus monkey studies, BMF-650 showed significant improvements in glucose stimulated insulin secretion, in line with findings from the human donor islet experiments. BMF-650 also demonstrated superior glucose control; Appetite suppression studies revealed that daily oral BMF-650 dosing significantly reduced food intake during peak drug concentration, with sustained effects throughout the day for a six-day study period; These findings highlight BMF-650’s potential as an oral treatment for diabetes and obesity."

New molecule • Preclinical • Diabetes • Metabolic Disorders • Obesity