Core Insights - Biomea Fusion, Inc. announced promising preclinical findings for BMF-650, an investigational oral GLP-1 receptor agonist, showing significant weight loss in obese non-human primates [1][3] Study Design and Key Preclinical Findings - The study involved 15 obese cynomolgus monkeys, with groups receiving either a vehicle or BMF-650 at doses of 10 mg/kg and 30 mg/kg for 28 days [7] - Results indicated a dose-dependent reduction in food intake, with average daily intake dropping to 35g/day (10 mg/kg) and 16g/day (30 mg/kg) compared to 109g/day for the control group [7] - Weight loss was significant, with reductions of 12% for the 10 mg/kg group and 15% for the 30 mg/kg group from baseline by Day 28 [7] - BMF-650 was well tolerated, showing no elevations in aminotransferase levels [7] BMF-650 Preclinical Highlights - BMF-650 demonstrated a favorable pharmacokinetic profile, with enhanced oral bioavailability and less variability compared to other oral GLP-1 RAs [9] - The compound showed robust glycemic control and appetite suppression, leading to pronounced weight reduction in preclinical models [9][10] - The company aims to submit an Investigational New Drug (IND) application in the second half of 2025, with a Phase I trial in obese volunteers expected to start in late 2025 [6][10] About Obesity - Obesity is a chronic disease affecting over 40% of adults in the U.S. and over 650 million adults globally, leading to serious health complications [11] - The condition is associated with metabolic disorders, cardiovascular diseases, and increased risks of chronic diseases [11] About GLP-1 Receptor Agonists - GLP-1 receptor agonists are medications that mimic the effects of the GLP-1 hormone, improving glycemic control and promoting weight loss in individuals with type 2 diabetes and obesity [12] About Biomea Fusion - Biomea Fusion focuses on developing oral small molecules for diabetes and obesity, including BMF-650, aimed at significantly improving patient outcomes [13]