Kintor Pharmaceutical administers first patient dosing of its androgen receptor antagonist, Pyrilutamide, in China for the treatment of acne vulgaris

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Kintor Pharmaceutical Limited, on Monday, announced the first patient dosing in its phase II clinical trial of KX-826 (Pyrilutamide) in China for the treatment of acne vulgaris. To date, there have been significant unmet medical needs as there has been no effective topical androgen inhibitor used for the acne vulgaris treatment in China.

The primary endpoint of the drug trials is the treatment success rate, based on the Investigator Global Assessment score, at the end of the trial. The clinical trial in China was the fusion design of phase I and phase II clinical trials for the treatment of acne vulgaris. The phase II clinical trial is a randomized, double-blind, placebo-controlled, multi-regional clinical study to assess the safety and efficacy of KX-826 (gel) in patients with mild to moderate acne vulgaris. 

The U.S. FDA approved the first androgen receptor (AR) antagonist for the treatment of acne in August 2020, which has paved the way for Kintor’s AR antagonist to conduct clinical trials in China. 

“We are delighted to see that KX-826, a topical AR antagonist with a clear target, has finished the first patient enrollment and dosing in its phase II clinical trial for acne vulgaris in China. KX-826’s phase I clinical trial in China has demonstrated a preliminary postive safety, pharmacokinetics and tolerability profile in term of dose-escalation and dosing frequency. We look forward to accelerating the phase II clinical trial to continue to evaluate KX-826’s safety, recommended dosage, and dosing frequency. We hope to bring a safe and effective treatment to people who suffer from acne vulgaris.”

Dr. Youzhi Tong, founder, Chairman, and Chief Executive Officer of Kintor Pharma

Acne vulgaris is the eighth most prevalent disease in the world, which is a common disease in particular in adolescents and young adults. It affects more than 640 million people. The pathogenesis of acne vulgaris is complicated. The influence of androgen and its receptor signaling pathway on sebaceous glands and sebum secretion is one of the important factors causing acne vulgaris. 

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