Core Insights - The company, 开拓药业-B (09939), has announced positive top-line data from the Phase II clinical trial of its self-developed KX-826 solution for treating hair loss, achieving primary endpoints with statistical significance and clinical relevance [1][2] Efficacy - The Phase II trial, which included 90 patients, demonstrated significant efficacy for both the 0.5% BID and 1.0% BID groups compared to the placebo group, with the 0.5% BID group showing an increase of 22.39 hairs/cm and the 1.0% BID group showing an increase of 21.87 hairs/cm, while the placebo group showed an increase of only 8.73 hairs/cm [1] - The 0.5% BID group had a statistically significant increase of 13.66 hairs/cm over the placebo (P=0.002), and the 1.0% BID group had an increase of 13.14 hairs/cm over the placebo (P=0.004) [1][2] - Hair Growth Assessment (HGA) metrics also showed significant improvement for both treatment groups compared to the placebo, with the 0.5% BID group showing statistical significance (P=0.000) and the 1.0% BID group also showing significance (P=0.013) [2] Safety - KX-826 demonstrated satisfactory safety and tolerability in the clinical trial, with a low incidence of adverse events and no reports of drug-related sexual dysfunction or new safety signals [2] - The Independent Data Monitoring Committee (IDMC) reviewed the results and recommended that the Phase III clinical trial continue based on the current safety and efficacy data, maintaining the same groups and sample sizes [2]
开拓药业-B(09939)：KX- 826 酊1.0%治疗中国成年男性雄激素脱发关键性临床试验II期阶段达到主要终点