Ardmore Shipping(ASC) Prnewswire·2024-11-12 11:30Core Insights - Ascletis Pharma Inc. has completed enrollment of 480 patients for a Phase III clinical trial of ASC40 (denifanstat), a once-daily oral tablet for treating moderate to severe acne, with topline results expected in Q2 2025 [1][2]. Group 1: Clinical Trial Details - The Phase III trial is a randomized, double-blind, placebo-controlled, multicenter study in China, evaluating the safety and efficacy of ASC40 [2]. - A total of 480 patients with moderate to severe acne vulgaris were randomized into two groups: one receiving 50 mg ASC40 and the other a matching placebo for 12 weeks [2]. - Primary efficacy endpoints include the proportion of patients achieving treatment success at week 12, percentage change from baseline in total lesion count, and percentage change in inflammatory lesion count at week 12 [3]. Group 2: Previous Trial Results - On May 2, 2023, Ascletis reported that the Phase II trial for ASC40 met primary and key secondary endpoints, showing 19.4% of patients achieved treatment success at week 12 compared to 5.1% for placebo, alongside a good safety profile [4]. Group 3: Drug Mechanism and Licensing - ASC40 is a first-in-class, once-daily oral selective small molecule inhibitor of fatty acid synthase (FASN), working by inhibiting facial sebum production and inflammation [5]. - The drug is licensed from Sagimet Biosciences Inc. for exclusive rights in Greater China [5]. Group 4: Company Overview - Ascletis Pharma Inc. is an innovative R&D-driven biotech company listed on the Hong Kong Stock Exchange, focusing on metabolic and viral diseases with multiple clinical stage drug candidates in its pipeline [7].