Core Viewpoint - The company has successfully achieved the primary endpoint in the Phase II clinical trial of its self-developed PROTAC compound GT20029 for the treatment of acne, demonstrating statistical significance and clinical relevance in efficacy, safety, and pharmacokinetic characteristics [1][2]. Efficacy - The Phase II clinical trial was a multi-center, randomized, double-blind, placebo-controlled study, evaluating GT20029 at doses of 0.5% and 1.0% once daily (QD) [1]. - In terms of total lesion count (excluding nodules), the P-values for the 0.5% QD and 1.0% QD groups compared to the placebo were 0.01 and 0.05, respectively [1]. - For non-inflammatory lesion count percentage change from baseline, the P-values were 0.14 for the 0.5% QD group and 0.09 for the 1.0% QD group; for inflammatory lesion count percentage change, both groups had P-values less than 0.01 compared to placebo [1]. Treatment Success Rate - The treatment success rate, defined by the Investigator's Global Assessment (IGA) score dropping to 0-1 with a decrease of at least 2 levels, showed P-values of 0.03 for the 0.5% QD group and 0.15 for the 1.0% QD group compared to placebo [2]. Safety - GT20029 gel demonstrated satisfactory safety and tolerability in the clinical trial, with a low overall incidence of adverse events [2]. - The incidence of drug-related adverse events was comparable between the 0.5% QD and 1.0% QD groups, both of which were lower than the placebo group, with all adverse events being of mild severity [2].
开拓药业-B(09939)：GT20029凝胶治疗痤疮中国II期临床试验达到主要终点