Kintor Doses First Group of Acne Patients in Phase I/II Clinical Trial of Pyrilutamide
There is no effective topical androgen inhibitor used for acne in China yet.
Kintor Pharmaceutical Limited successfully dosed the first group of patients in the clinical trial of Pyrilutamide as a treatment for the acne vulgaris.
The Phase I/II clinical trial in China is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of Pyrilutamide in patients with mild to moderate acne vulgaris.
Pyrilutamide is a well-targeted topical androgen receptor (AR) antagonist. It competitively inhibits the binding of androgen in the skin tissue to the androgen receptor and can locally control the activation of the receptor signaling pathway caused by androgen hyperactivity without changing the activity of the androgen receptor signaling pathway in the human body.
"The U.S. FDA approved the first AR antagonist for the treatment of acne in August 2020, which has paved the way for our AR antagonist to conduct clinical trials in China. Pyrilutamide, a topical AR antagonist with a specific target, can inhibit the combination of androgen receptor and androgen in hair follicle sebaceous glands, thereby treating acne vulgaris. Through the fusion design of phase I and phase II clinical trials, we hope to speed up the exploration of the safety, effective dosage and frequency of use of Pyrilutamide in clinical study, so as to relieve appearance anxiety of acne patients as soon as possible," says Dr. Tong Youzhi, Founder, Chairman and Chief Executive Officer of Kintor Pharmaceutical, in a news release.