Core Viewpoint - The company has successfully completed a Phase II clinical trial for its self-developed PROTAC compound GT20029, targeting androgen receptors for acne treatment, achieving statistically significant and clinically meaningful results [1][2] Efficacy - The Phase II trial was a multi-center, randomized, double-blind, placebo-controlled study, evaluating the efficacy, safety, and pharmacokinetics of GT20029 at doses of 0.5% and 1.0% administered once daily [1] - In terms of efficacy, the total lesion count (excluding nodules) showed P-values of 0.01 for the 0.5% group and 0.05 for the 1.0% group compared to the placebo [1] - For inflammatory lesion count changes from baseline, both the 0.5% and 1.0% groups had P-values less than 0.01 compared to the 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% group and 0.15 for the 1.0% group compared to the 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% and 1.0% groups, both being lower than that of the placebo group, with all events classified as mild [2]
开拓药业-B：GT20029凝胶治疗痤疮中国II期临床试验达到主要终点