Suzhou, January 24, 2022 - Kintor Pharmaceutical Limited (“Kintor Pharma,” HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, today announced the first patient dosing in its phase II clinical trial of KX-826("pyrilutamide") in China for the treatment of acne vulgaris.

The clinical trial in China for the treatment of acne vulgaris was the fusion design of phase I and phase II clinical trials. 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 phase II sample size is 160, and the trial duration is 12 weeks. The primary endpoint is the treatment success rate (based on the Investigator Global Assessment —IGA score) at the end of week 12. This phase II clinical trial will be carried out in 6 medical institutions across China, with Professor Xiang Leihong from Huashan Hospital affiliated to Fudan University as the leading principal investigator (leading PI).

Acne vulgaris is the eighth most prevalent disease in the world[1], which is a common disease in particular in adolescents and young adults. Acne vulgaris affects more than 640 millions people[2]. 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 for the treatment of acne in August 2020, which has paved the way for our AR antagonist to conduct clinical trials in China. 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.

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

About KX-826

KX-826 is an androgen receptor (AR) antagonist and apotential first-in-class topical drug for the treatment of androgenetic alopecia (AGA) and acne vulgaris. For the acne vulgaris indication, KX-826, a topical AR antagonist with a specific target, can inhibit the combination of androgen receptor and androgenin hair follicle sebaceous glands, thereby treating acne vulgaris.

[1] Tan JK, Bhate K. A global perspective on the epidemiology of acne. Br J Dermatol. 2015;172 Suppl 1:3-12.

[2] Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990- 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2163- 2196.