Kintor Pharmaceutical has concluded the subject enrolment in Phase II clinical trial of KX-826 (pyrilutamide) to treat female androgenetic alopecia (AGA) in China.
The enrolment concluded in nearly four months of the launch of the trial with a total of 160 patients.
An androgen receptor (AR) antagonist, KX-826 is a topical drug to treat AGA and acne vulgaris.
The randomised, double-blind, placebo-controlled, multi-regional Phase II trial will analyse the safety and efficacy of KX-826 to treat AGA in adult female subjects.
The variation in non-vellus target area hair counts (TAHC) from baseline at week 24 will be the trial’s primary endpoint.
Peking University People’s Hospital is leading the study with 15 hospitals taking part in it.
Kintor Pharma founder, chairman and CEO Dr Youzhi Tong said: “We look forward to receiving preliminary data from this study in Q4 this year, further broadening the clinical potential of KX-826 in female AGA patients and accelerating KX-826’s Phase III clinical trial for male AGA patients in China, so as to meet the treatment needs of people suffering from hair loss as soon as possible.”
In September last year, the company reported that a Phase II trial of KX-826 on adult male subjects with AGA met the primary endpoint. The drug also demonstrated to possess favourable safety profile.
Currently, Kintor is carrying out Phase II trials of the drug for female AGA patients in China.
Another Phase II trial of KX-826 is underway in male subjects with AGA in the US.
The latest development comes after Kintor dosed the first subject in the Phase II US trial.