Kintor Pharmaceutical Limited, a clinical-stage biotechnology company developing innovative small-molecule and biological therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for its novel drug GT20029 for treating androgenetic alopecia (AGA) and acne subjects. GT20029 is the first topical Proteolysis Targeting Chimera (PROTAC) compound globally which has entered the clinical stage. Following China Center for Drug Evaluation (CDE) 's IND approval for GT20029's clinical study in April 2021, the clinical study in the US is about to start.

Dr. Tong Youzhi, the founder, Chairman, and CEO of Kintor Pharmaceutical, commented, "Kintor started to build up PROTAC platform in 2018, based on which Kintor developed AR-PROTAC (GT20029), an innovative topical drug. This clearance is another international clinical trial clearance obtained by the company after FDA just greenlighted pyrilutamide (KX-826)'s phase II clinical trial for the treatment of AGA, further expanding the international distribution of Kintor's innovative drug pipelines. Both indications of androgenetic alopecia and acne have huge unmet clinical needs, and we hope to accelerate the clinical progress to provide safe and effective treatments for people who suffer from androgenetic alopecia and acne."

The trial is a randomized, double-blind, vehicle-controlled, parallel-group, dose-escalation study in subjects to evaluate the safety, tolerability, and pharmacokinetics of GT20029 following topical single and multiple ascending dose administration.

The excessive activation of systemic and local androgen receptor pathways is an important link in the pathogenesis of androgenetic alopecia and acne. GT20029 can effectively block the androgen receptor pathway and physiological function by degrading the AR protein. According to preclinical studies, the efficacy of GT20029 appears superior to other small molecule AR inhibitors. Topical GT20029 has also been shown to avoid systemic exposure and many of the side effects of oral androgen signaling pathway inhibitors.

In China, the CDE accepted GT20029's phase I clinical trial in April 2021. First patient dosing in China is expected in this month.

About GT20029

GT20029 is atopical androgen receptor (AR) degrader developed using Kintor's proprietary Proteolysis Targeting Chimera (PROTAC) platform. The mechanism of action of GT20029 is to recruit the AR protein to the E3 ubiquitin ligase for degradation. 

About Kintor Pharmaceutical Limited

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 cancer, alopecia, and acne. For more information, visit www.kintor.com.cn.

About Androgenetic Alopecia

Androgenetic alopecia, or hair loss mediated by the presence of the androgen dihydrotestosterone, is the most common form of hair loss in men and women. It is also known as male pattern baldness or female pattern baldness. Androgenetic alopecia can start as early as a person's teens and risk increases with age; more than 50 percent of men over age 50 have some degree of hair loss. In women, hair loss is most likely after menopause.

About Acne

Acne, or acne vulgaris, is a common skin condition characterized by the presence of blackheads, whiteheads, and other types of pimples on the skin. Among the causes of acne are genetics, stress, high humidity, use of oily or greasy personal care products and fluctuating hormone levels. Acne is estimated to affect 9.4% of the global population, making it the eighth most prevalent disease worldwide.