KINTOR PHARMA-B(09939): KX- 826 1.0% solution achieved the primary endpoint in the Phase II clinical trial for treating androgenetic alopecia in adult males in China.

KINTOR PHARMA-B (09939) announced that the pivotal Phase II clinical trial of its self-developed and potentially first-in-class KX-826 solution 1.0% for the treatment of hair loss has achieved top-line data. The data shows that the Phase II trial met its primary endpoint with statistical significance and clinical significance, demonstrating excellent efficacy and safety. This pivotal clinical trial is a multicenter, randomized, double-blind, placebo-controlled adaptive Phase II/III study designed to evaluate the effectiveness and safety of KX-826 solution 1.0% and 0.5% topical treatment in Chinese adult male patients with AGA. The trial utilized a seamless Phase II/III design, with Professor Zhang Jianzhong and Professor Zhou Cheng from Peking University People's Hospital serving as principal investigators, administering treatment for 24 weeks and a one-month safety observation period according to the prescribed dosage. The analysis of the 90 patients enrolled in the Phase II trial showed: - Efficacy: Compared to the placebo group, both the 0.5% BID (twice daily) group and the 1.0% BID group showed statistically significant and clinically meaningful efficacy advantages. The 0.5% BID group had an increase of 22.39 hairs/cm2 in the target area non-vellus hair count (TAHC) compared to baseline, while the 1.0% BID group had an increase of 21.87 hairs/cm2, and the placebo group had an increase of 8.73 hairs/cm2. The 0.5% BID group showed a statistically significant increase of 13.66 hairs/cm2 compared to the placebo group (P=0.002), and the 1.0% BID group showed a statistically significant increase of 13.14 hairs/cm2 compared to the placebo group (P=0.004). Both the 0.5% BID group and the 1.0% BID group showed significant improvements in hair growth assessment (HGA) compared to the placebo group, with significant treatment effects. After 24 weeks of treatment, the HGA index in the 0.5% BID group showed a statistically significant improvement compared to the placebo group (P=0.000), and the 1.0% BID group showed a statistically significant improvement compared to the placebo group (P=0.013). - Safety: KX-826 solution showed satisfactory safety and tolerability in the clinical trial, with a low overall rate of adverse events. There were no drug-related adverse events related to sexual dysfunction throughout the study, and no new safety signals were observed, indicating good safety. The analysis results were reviewed by an independent data monitoring committee (IDMC), with the main recommendation being to continue the Phase III clinical trial based on the current safety and efficacy data, with no changes in treatment groups or sample sizes.