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Ascletis Announces Positive Topline Results of Phase Ib Studies of ASC47 Monotherapy in Australia and U.S. FDA Clearance of IND Application for ASC47 in Combination with Semaglutide
ASCArdmore Shipping(ASC) Prnewswire·2025-03-11 23:30

Core Insights - Ascletis Pharma Inc. announced positive pharmacokinetic and weight loss data for its drug candidate ASC47 from Phase Ib studies in Australia, targeting obesity and elevated LDL-C levels [1][8] Group 1: Drug Efficacy and Mechanism - ASC47 demonstrated a half-life of up to 26 days in healthy subjects and 40 days in patients with obesity, supporting administration every month to every two months [2][8] - In patients with obesity, ASC47 showed a placebo-adjusted mean weight loss of 0.2% at day 29, 1.0% at day 43, and peaked at 1.7% at day 50, indicating a slower weight loss rate due to its mechanism of action involving UCP-1-mediated thermogenesis [3][8] - ASC47 resulted in significant placebo-adjusted reductions in LDL-C by up to 22% and total cholesterol by up to 16%, confirming its target engagement in humans [4][8] Group 2: Safety and Tolerability - ASC47 was well tolerated at doses up to 90 mg, with no serious adverse events reported and most adverse events being mild [5][8] - There were no significant changes in heart rate or liver enzymes, indicating a favorable safety profile [5][8] Group 3: Future Development Plans - A multiple ascending dose study of ASC47 for obesity treatment is expected to begin in the second half of 2025 [5][9] - The U.S. FDA has cleared an IND application for ASC47 in combination with semaglutide, with the first patient expected to be dosed by the end of Q2 2025 [7][8] Group 4: Company Overview - Ascletis Pharma Inc. is a biotech company focused on R&D, covering the entire value chain from drug discovery to GMP manufacturing, with a focus on metabolic and viral diseases [14]