KINTOR PHARMA-B: KX-826 Long-term Safety for Treating Hair Loss Phase III Clinical Trial Achieves Primary Endpoint

According to the Zhitong Finance APP, KINTOR PHARMA-B (09939) announced that its independently developed, potentially first-in-class KX-826 tincture for the treatment of hair loss has obtained topline data from a long-term safety Phase III clinical trial. The data shows that this long-term safety clinical trial has achieved its primary endpoint, with results demonstrating statistical significance and clinical relevance, and both safety and efficacy have performed excellently.

This long-term safety clinical trial is a multicenter, open-label study aimed at evaluating the long-term safety of KX-826 topical treatment in Chinese patients with hair loss (treatment duration of 52 weeks). The trial was conducted at 16 clinical research centers nationwide, with Professor Zhang Jianzhong from Peking University People's Hospital serving as the principal investigator. The primary endpoint of the trial is the occurrence of treatment-emergent adverse events (TEAE) during the study, while secondary endpoints include changes from baseline in the number of terminal hairs in the target area (TAHC) and other efficacy and safety indicators. The trial used KX-826 tincture at a dosage of 0.5% BID (twice daily) as the investigational drug. The clinical trial results show:

In terms of safety: KX-826 tincture demonstrated satisfactory safety and tolerability in the clinical trial, with a low overall incidence of adverse events and no reported fatalities. Throughout the study, there were no drug-related adverse reactions related to sexual dysfunction, and no safety signals were observed, indicating good safety.

In terms of efficacy: After 52 weeks of treatment, patients showed positive signals in both TAHC and the diameter of terminal hairs in the target area (TAHW), with significant increases from baseline, indicating effective treatment with statistically significant results (P<0.0001). In the target population, 46% of subjects had a change in TAHC of ≥10 hairs/cm2 from baseline at week 52, and 20% had a change of ≥20 hairs/cm2.

Both investigator and subject assessments of hair growth (HGA) showed varying degrees of improvement from baseline, with significant treatment effects. The results indicated that after 52 weeks of treatment, the effective rate assessed by investigators for male patients (HGA score ≥1) was 53%, and for female patients, it was 48.4%. Patients also exhibited a positive trend in treatment effect changes in their self-assessments at different time points