Long-Term Safety Phase III Clinical Trial Of KX-826 For The Treatment Of AGA Reached Primary Endpoint
Release time：2025-03-20 18:33
Suzhou, 20 March, 2025-Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), announced that the long-term safety phase III clinical trial of its in-house developed and potential first-in-class KX-826 tincture for the treatment of AGA has obtained top-line results. Results indicated that the Long-term Safety Clinical Trial has reached its primary endpoint with statistically significant and clinically meaningful outcomes, demonstrating excellent safety and efficacy.
The Long-term Safety Clinical Trial is a multi-center, open-label study designed to evaluate the long-term safety of the topical use of KX-826 for the treatment of AGA patients in China (treatment period of 52 weeks). The Long-term Safety Clinical Trial involves a total of 16 clinical research centers in China, with Professor Jianzhong Zhang (張建中) from Peking University People’s Hospital as the lead principal investigator. The primary endpoint of the trial is the incidence of treatment-emergent adverse events (“TEAE”) occurred during the study. Secondary endpoints include efficacy as measured by the change in the target area non-vellus hair counts (“TAHC”) from baseline and other safety indicators. This trial adopted KX-826 tincture 0.5% BID (i.e. twice a day) as the drug-related dosage. Results of the clinical trial showed that
Regarding safety, KX-826 tincture exhibited satisfactory safety and tolerability in clinical trial, with a low incidence of overall adverse events and no death case. No drug-related sexual dysfunction adverse reactions were observed during the entire study period, which indicated an excellent favorable safety profile without observing any safety signals.
In terms of efficacy, after 52 weeks’ treatment, patients showed positive signals in both TAHC and target area non-vellus hair width (“TAHW”) with an increase from baseline, demonstrating effective treatment, and the results are statistically significant (P<0.0001). Among the target populations, at 52 weeks, the patients with ≥10 hairs/cm2 change in TAHC from baseline accounted for 46%, the patients with ≥20 hairs/cm2 change accounted for 20%.
The hair growth assessment (“HGA”) indicators from investigators and patients both experienced various degrees of improvement from baseline, with a significant therapeutic effect. The results showed that after the treatment of 52 weeks, the efficacy rates (HGA score ≥1) as assessed by HGA investigators in male patients was 53%, and the efficacy rates as assessed by HGA investigators in female patients was 48.4%. In the self-assessments at different time points, patients also demonstrated a positive trend of change in therapeutic efficacy.
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