BMF-650 / Biomea Fusion - LARVOL DELTA

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