Kintor Pharma Announces Completion of Subject Enrollment and Dosing in Phase I Clinical Trial of AR-PROTAC(GT20029) in China

SUZHOU, China, Aug. 9, 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 and dosing of 92 subjects for its phase I clinical trial of GT20029 in China for the treatment of androgenetic alopecia (AGA) and acne on August 8, 2022.

Developed using Kintor's proprietary Proteolysis Targeting Chimera (PROTAC) platform, GT20029 is the world's first topical androgen receptor (AR) PROTAC compound which entered the clinical stage.

The phase I clinical trial is a randomized, double-blind, placebo-controlled study to evaluate the safety and pharmacokinetics of GT20029 (gel/tincture) following topical administration in single dose and multiple ascending doses in healthy subjects. The leading principal investigators (leading PIs) of the phase I clinical trial are Professor Zhang Jing and Associate Professor Wu Xiaojie from Huashan Hospital affiliated to Fudan University. We expect to complete the database lock and preform data analysis in Q4, 2022.

In preclinical studies, GT20029 has demonstrated a positive safety profile and was shown to effectively block the AR pathway and physiological function by degrading the AR protein. In addition, by limiting skin penetration, GT20029 inhibits androgenetic effects locally in peripheral skin tissues, avoiding systemic effects and increasing its safety profile.

Dr. Youzhi Tong, founder, Chairman, and CEO of Kintor Pharma, commented, "Both indications of AGA and acne have great unmet clinical needs. As the world's first company to develop a topical AR-PROTAC compound, Kintor is currently conducting phase I clinical trials of GT20029 in China and the United States. We hope to advance a new and effective treatment option for hundreds of millions of patients with AGA and acne worldwide, as well as provide a successful case for the application of PROTAC technology to local drug targets on skin surfaces."

About GT20029

GT20029 is a topical androgen receptor (AR) receptor degrader using Kintor's proprietary Proteolysis Targeting Chimera (PROTAC) Platform. GT20029 can effectively block the androgen receptor pathway and its physiological function by degrading the AR protein. The China Center for Drug Evaluation (CDE) and the US Food and Drug Administration (FDA) cleared GT20029's phase clinical trial for treating androgenetic alopecia (AGA) and acne in April 2021 and July 2021, respectively. In July 2021, Kintor announced the dosing of first batch of subjects in its China phase I clinical trial of GT20029. In February 2022, Kintor announced the dosing of first subject in its US phase I clinical trial of GT20029. 

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

SOURCE Kintor Pharma