Core Insights - Ascletis Pharma Inc. announced positive topline results from a U.S. Phase II, 24-week study for its ASC30 subcutaneous depot formulation, achieving a statistically significant and clinically meaningful placebo-adjusted mean weight loss of 7.5% at week 16 after three monthly doses [1] Group 1: Study Results - The Phase II study involved 65 participants with obesity or overweight, achieving its primary endpoint with a mean weight loss of 6.3% at week 12 and 7.5% at week 16 for the ASC30 SQ depot formulation A1 [1] - The study demonstrated that ASC30 maintained weight loss for four months following the last dose, indicating potential for quarterly dosing as a maintenance therapy [1] - ASC30 SQ depot formulation A1 showed a safety and tolerability profile consistent with the GLP-1 drug class, with no discontinuations due to adverse events [1] Group 2: Formulation Details - ASC30 SQ depot formulation A1 was administered in three doses of 400 mg each, achieving placebo-adjusted mean body weight loss of 2.7%, 5.5%, 6.3%, and 7.5% at weeks 4, 8, 12, and 16 respectively [1] - The formulation demonstrated therapeutic drug exposures over a 16-week maintenance period, with mean weight loss of 5.5% at week 8, 6.4% at week 20, and 5.8% at week 24 [1] - ASC30 is the first GLP-1 to achieve effective weight loss with once-monthly injection without requiring lead-in weekly injections [1] Group 3: Company Overview - Ascletis Pharma Inc. is focused on developing and commercializing therapeutics for metabolic diseases, utilizing proprietary technologies such as Artificial Intelligence-assisted Structure-Based Drug Discovery and Ultra-Long-Acting Platform [2] - ASC30 is a new chemical entity with U.S. and global patent protection through 2044, designed for both oral and subcutaneous administration [2] - The company is listed on the Hong Kong Stock Exchange and has developed multiple drug candidates for chronic weight management [2]
Ascletis Announces Positive Topline Results from U.S. Phase II, 24-Week Study for Its Ultra-Long-Acting Subcutaneous Depot Formulations of Small Molecule GLP-1R Agonist ASC30 for Obesity