Kintor Pharma completes first batch patient dosing in phase I/II clinical trial of Pyrilutamide to treat acne vulgaris
Kintor Pharmaceutical Limited, a clinical-stage biotechnology company, announced the clinical trial of Pyrilutamide as a treatment for the acne vulgaris has completed the first batch of patients enrolment and successfully dosed in China.
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.
Acne vulgaris is a chronic inflammatory skin disease of the hair follicle sebaceous gland unit, which is a common disease in particular in adolescents and young adults. According to Frost & Sullivan, in 2018, more than 118.9 million Chinese patients aged between 10 and 25 had acne vulgaris. The total number of patients is expected to be 122.5 million in 2028.
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. 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.
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.
Dr. Tong Youzhi, founder, chairman and chief executive officer of Kintor Pharmaceutical, commented, “The US 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.”
Kintor Pharmaceuticals is developing and commercializing a robust pipeline of small molecule and biological drugs for androgen-receptor-related disease areas with unmet medical needs, including Covid-19, prostate, breast and liver cancer, alopecia and acne.
