Kintor Pharmaceutical Ltd (HKG: 9939), a China-based pharmaceutical company, has released topline data from a Phase III clinical study for its pipeline candidate KX-826, a potential first-in-class androgen receptor (AR) antagonist for the treatment of androgenetic alopecia (AGA).
The multi-center, open-label, long-term safety Phase III clinical trial conducted in China evaluated the topical drug at a 0.5% concentration applied twice daily in Chinese males with AGA. The early data indicate that KX-826 demonstrated excellent overall safety, with no major adverse reactions reported. After 24 weeks of treatment, the KX-826 group showed significant hair growth compared to baseline, achieving statistical significance (P<0.001). While the difference in Target Area Hair Counts (TAHC) between the KX-826 group and the placebo group was not statistically significant, it showed a trend in efficacy at all visit points.
KX-826 is also under development for acne and is recognized as the world’s first drug of its kind to reach a regulatory Phase III study for AGA. KX-826 competes with dihydrotestosterone (DHT) for binding to AR, thereby locally blocking androgen-mediated signaling, limiting hair follicle miniaturization, and promoting the growth of peripheral hair. The drug rapidly metabolizes into inactive metabolites upon reaching the circulatory system, resulting in minimal impact on the systemic AR signaling pathway and exhibiting good safety.- Flcube.com
