Ascletis Announces Promising Results from a Phase I Study in Australia for First-in-Class Muscle-Preserving Weight Loss Drug Candidate ASC47 for the Treatment of Obesity

Core Insights - Ascletis Pharma Inc. announced positive topline results from a Phase I single ascending dose (SAD) study of ASC47, a first-in-class muscle-preserving weight loss drug candidate for obesity treatment, demonstrating a half-life of 21 days and supporting once-monthly administration [1][2][4] Phase I Clinical Data - ASC47 showed significant reductions in lipid biomarkers at day 29 post-injection in subjects with elevated low-density lipoprotein cholesterol (LDL-C) [2] - The SAD study included five cohorts with doses ranging from 10 mg to 360 mg, with a total of 20 subjects receiving ASC47 or placebo, showing a favorable tolerability profile with no serious adverse events [3] Preclinical Efficacy Data - In preclinical studies, ASC47 demonstrated superior fat mass reduction compared to semaglutide and tirzepatide, with reductions of -63.5% and -68.0% respectively, while also increasing total muscle mass [6][8] - ASC47's unique properties allow for targeted delivery to adipose tissue, achieving drug concentrations seven times higher than the predicted human efficacious concentration [11] Mechanisms of Action - ASC47 operates through uncoupling protein 1 (UCP-1)-mediated thermogenesis in adipose tissue, which is a key mechanism for fat reduction and muscle preservation [13][14] Future Studies - Ascletis has initiated a second Phase I study of ASC47 in patients with obesity, with topline data expected in Q1 2025, alongside additional Phase I studies including multiple ascending dose (MAD) studies [4][5]