Kintor Pharmaceutical Limited, a clinical-stage biotechnology company, announced that the company has completed the enrollment of 160 patients for its phase II clinical trial of KX-826 (pyrilutamide) in China for the treatment of female androgenetic alopecia (AGA) on 4 March 2022, which has only taken around four months since its launch.
The population of those who suffer from hair loss has a large number and tends to be younger, and hair loss is gradually becoming the focus of the whole society. By the end of 2020, the number of hair loss in China had exceeded 252 million. AGA, known as the most common type of hair loss, is a condition that can affect both men and women. In China, the prevalence of AGA is approximately 21.3% in males and 6.0% in females.
Dr. Youzhi Tong, founder, chairman, and CEO of Kintor Pharma commented, "We are delighted to see the completion of the enrollment of all subjects in the phase II clinical trial of KX-826, and I would like to give special thanks to all the investigators, subjects and my team who participated in this clinical trial. In China, one in 20 female adults suffers from hair loss, and the ratio in male adults is 5:1. Hair loss has an important impact on patients' mental health and quality of life. 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.”
The phase II trial is a randomized, double-blind, placebo-controlled, multi-regional study to evaluate the efficacy and safety of KX-826 for the treatment of AGA in adult females (N=160). The primary endpoint for the trial is the change from baseline in non-vellus target area hair counts (TAHC) at week 24. Peking University People’s Hospital leads the trial, with 15 hospitals participating in. Professor Zhang Jianzhong, director of the Department of Dermatology, Peking University People’s Hospital and chairman of the 13th session of the Dermatology and Venereology Branch of the Chinese Medical Association, is the leading principal investigator (leading PI) of the phase II clinical trial of KX-826 for female AGA patients.
KX-826 is an androgen receptor (AR) antagonist and a potential first-in-class topical drug for the treatment of AGA and acne vulgaris. For the AGA indication, on 8 September 2021, Kintor Pharma announced that the primary endpoint of the phase II clinical trial of KX-826 on adult male patients was met, as results showed good efficacy and safety profile. Kintor Pharma now is conducting a phase III clinical trial of KX-826 in China and a phase II clinical trial of KX-826 in the US for male AGA patients, and conducting a phase II clinical trial of KX-826 for female AGA patients in China. For the acne vulgaris indication, Kintor Pharma is conducting a phase II clinical trial of KX-826 in China for the treatment of acne vulgaris