Kintor Pharmaceutical Limited announced results of phase II clinical trial of pyrilutamide (KX-826), a potential first-in-class topical drug developed by the company, in China for the treatment of adult female androgeneticalopecia (AGA). In the study, KX-826 has demonstrated clinically meaningful and statistically significant improvement in hair growth as measured by target area non-vellus hair count (TAHC). In addition, its safety profile was favorable.

This trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of KX-826 for the treatment of AGA in female adults. Professor Jianzhong Zhang, chairman of the Department of Dermatology, Peking University People's Hospital, is the leading principal investigator (Leading PI). The primary endpoint for the trial is the change from baseline versus placebo in TAHC at the end of week 24.

A total of 160 female AGA patients who have met Savin Scale (D3-D6) were enrolled in the phase II clinical trial. 119 patients were randomly assigned to four treatment groups, including KX-826 2.5mg (0.25%) once daily (QD), KX-826 2.5mg (0.25%) twice daily (BID), KX-826 5mg (0.5%) QD and KX-826 5mg (0.5%) BID; and 41 patients were assigned to placebo groups (QD and BID). The results haven shown that, The TAHC of the KX-826 5mg (0.5%) QD group has increased by 11.39 hair counts per cm2 compared with the placebo group from baseline after the treatment of 24 weeks, which was statistically significant (P=0.0087).

In addition, KX-826 has demonstrated efficacy as early as at the end of week 12. The recommended dose for phase III clinical trial for female AGA in China is determined as KX-826 5mg (0.5%) QD. The overall safety profile of KX-826 was favorable.

The majority of treatment emerged adverse events (TEAE) were mild and similar to those of placebo. No TEAE resulted in patient withdrawal from the trial, nor death was reported.