Suzhou, March 6, 2022 – Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapies, today announced that the company has completed recruiting of 160 patients for its phase II clinical trial of KX-826 (“pyrilutamide”) in China for the treatment of female androgenetic alopecia (AGA) on March 4, 2022, which has only lasted about four months since its initiation .
The population of those who suffer from hair loss is large 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 cases 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 men and 6.0% in women*.
Dr. Youzhi Tong, Founder, President and CEO of Kintor Pharma, said, “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 thank especially all the investigators, subjects and my team who participated in this clinical trial. In China, one in 20 adult women suffer from hair loss, and the ratio among adult men is 5:1. Hair loss has a significant impact on the mental health of patients. We look forward to receiving preliminary data from this study in the fourth quarter of this year, further expanding the clinical potential of KX-826 in female AGA patients and accelerating the Phase III clinical trial of KX-826 for male AGA patients. in China, in order to meet the treatment needs of people suffering from hair loss as soon as possible.”
About the trial
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 women (N=160). The primary endpoint of the trial is change from baseline in hair count in the target non-hairy area (TAHC) at week 24. Peking University People’s Hospital leads the trial, in which 15 hospitals are participating. 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 Principal Investigator (Principal PI) of the clinical trial of phase II of KX-826 for patients with AGA.
About the KX-826
KX-826 is an androgen receptor (AR) antagonist and a potential first-class topical drug for the treatment of AGA and acne vulgaris. For the AGA indication, on September 8, 2021, Kintor Pharma announced that the primary endpoint of the Phase II clinical trial of KX-826 in adult male patients was met, as results showed a good efficacy and safety profile. Kintor Pharma is currently conducting a Phase III clinical trial of KX-826 in China and a Phase II clinical trial of KX-826 in the United States for male AGA patients, and is conducting a Phase II clinical trial of KX -826 for 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.
* Guidelines for Diagnosis and Treatment of Androgenetic Alopecia in China