Kintor Pharma Announces Completion of Patient Enrollment in Phase II Clinical Trial of KX-826 for Acne Vulgaris in China

SUZHOU, China, Oct. 16, 2022 /PRNewswire/ -- Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, today 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 acne vulgaris on 14 October 2022.

The phase II clinical trial is a randomized, double-blind, placebo-controlled, multi-regional clinical study to evaluate the safety and efficacy of KX-826 (gel) in patients with mild to moderate acne vulgaris. The primary endpoint is the treatment success rate in each group at the end of week 12 (according to the 5-point Investigator Global Assessment ("IGA") scale, subjects whose IGA scale decreases by not less than two levels to 0-1 defined as "success".).

Dr. Youzhi Tong, founder, Chairman, and Chief Executive Officer of Kintor Pharma, commented, "We are delighted to see the completion of the enrollment of all patients in its phase II clinical trial of KX-826 for acne vulgaris in China. And I would like to give special thanks to all the investigators and my team who participated in this clinical trial, especially Professor Leihong Xiang from Huashan Hospital affiliated to Fudan University as the leading principal investigator (leading PI). KX-826's clinical trial in China for treating acne vulgaris was the combined design of phase I and phase II clinical trials. KX-826's phase I clinical trial has demonstrated a preliminary positive safety and tolerability profile in terms of dose-escalation and multiple topical doses applications per day for local use. We expect that KX-826 continues to demonstrate good efficacy and safety in phase II clinical trial to benefit more people suffering from acne vulgaris."

Acne vulgaris is the eighth most prevalent disease in the world, which is a common disease in particular in adolescents and young adults. Acne vulgaris affects more than 740 millions 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. The U.S. FDA approved the first androgen receptor (AR) antagonist in the past 40 years for the treatment of acne in August 2020, which had paved the way for our AR antagonist to conduct clinical trials in China. To date, there has been significant unmet medical needs as no effective topical AR antagonist was approved for the acne vulgaris treatment in China.

KX-826 is an AR antagonist and a potential first-in-class topical drug for the treatment of androgenetic alopecia (AGA) and acne vulgaris. For the acne vulgaris indication, KX-826 could inhibit the combination of androgen receptor and androgen in hair follicle sebaceous glands that reduces sebum production, thereby treating acne vulgaris. For the AGA indication, 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. Kintor is also conducting a phase II clinical trial of KX-826 for female AGA patients in China. 

Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancers, alopecia and acne. For more information, visit www.kintor.com.cn.

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SOURCE Kintor Pharmaceuticals