Kintor Pharmaceutical has dosed the first participant in the Phase III clinical trial of KX-826 (pyrilutamide) to treat male androgenic alopecia (AGA) patients in China.
An androgen receptor (AR) antagonist, KX-826 is claimed to be a first-in-class topical drug developed to treat AGA and acne vulgaris.
In November last year, China’s National Medical Products Administration (NMPA) granted approval to conduct the pivotal Phase III clinical trial of KX-826.
The placebo-controlled, randomised, double-blind, multi-regional pivotal study will assess KX-826’s safety and efficacy to treat male patients with AGA in China.
Huashan Hospital affiliated to Fudan University and Peking University People’s Hospital are leading the Phase III clinical trial. About 26 hospitals will participate in the trial.
The pivotal study is planned to recruit 416 participants and will have 24 weeks duration.
The change from baseline in non-vellus target area hair count (TAHC) at the end of 24 week will be the trial’s primary goal.
Kintor Pharmaceutical founder, chairman, and CEO Dr Youzhi Tong said: “Kintor’s team has executed with high efficiency from the NMPA’s clearance to the first dosing of this phase III clinical trial with around one month.
“This phase III clinical trial will be carried out in 26 top dermatology medical institutions across China.
“We look forward to completing the planned 416 subjects enrollment by June 2022, and the follow-up medical evaluation (6 months study + 1 month follow-up) within the year.
The trial is expected to be completed this year.
In October last year, the company dosed the first subject of the Phase III clinical trial of proxalutamide to treat hospitalised Covid-19 patients in the US.