Kintor Pharma's investigational hair loss treatment KX-826 has demonstrated statistically significant efficacy in treating male androgenetic alopecia (AGA) in a pivotal Phase II clinical trial. The topical tincture achieved its primary research endpoint with both dosing regimens showing meaningful hair growth improvements over placebo after 24 weeks of treatment.
Trial Design and Patient Population
The multicenter, randomized, double-blind, placebo-controlled study employed a Phase II/III adaptive design to evaluate KX-826's efficacy and safety in Chinese adult male AGA patients. Led by principal investigators Professor Zhang Jianzhong and Professor Zhou Cheng from Peking University People's Hospital, the trial administered treatments at specified dosages for 24 weeks followed by one month of safety observation. The Phase II stage analyzed results from 90 enrolled patients.
Efficacy Results Show Significant Hair Growth
The primary efficacy measure, target area non-vellus hair counts (TAHC), demonstrated substantial improvements in both active treatment groups compared to placebo. The 0.5% twice-daily (BID) group showed a TAHC increase of 22.39 hairs/cm² from baseline, while the 1.0% BID group increased by 21.87 hairs/cm² from baseline. In contrast, the placebo group showed only an 8.73 hairs/cm² increase from baseline.
When compared directly to placebo, the 0.5% BID group achieved a 13.66 hairs/cm² increase (P=0.002), while the 1.0% BID group showed a 13.14 hairs/cm² increase (P=0.004), both reaching statistical significance.
Hair Growth Assessment (HGA) indicators evaluated by investigators further supported the treatment's efficacy. After 24 weeks of treatment, both active groups demonstrated significant improvements over placebo, with the 0.5% BID group achieving P=0.000 and the 1.0% BID group reaching P=0.013 compared to placebo.
Safety Profile Supports Continued Development
KX-826 demonstrated satisfactory safety and tolerability throughout the clinical trial, with a low overall incidence of adverse events. Notably, no drug-related adverse reactions related to sexual dysfunction occurred during the study, addressing a common concern with existing hair loss treatments. No new safety signals were identified during the trial period.
Regulatory Path Forward
An independent Data Monitoring Committee (IDMC) reviewed the Phase II analysis results and recommended proceeding to Phase III clinical trials without modifications to study groups or sample sizes. This recommendation was based on the current safety and efficacy data demonstrating the treatment's potential as a first-in-class therapy for male pattern baldness.
The seamless Phase II/III adaptive design allows for efficient transition to the next phase of development, potentially accelerating the path to regulatory approval for this novel androgenetic alopecia treatment.
