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

SUZHOU, China, Oct. 27, 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 120 subjects for its U.S. phase I clinical trial of GT20029 for the treatment of androgenetic alopecia (AGA) and acne on 25 October 2022.

Developed through Kintor Pharma's proprietary Proteolysis Targeting Chimera (PROTAC) platform, GT20029 is the first topical PROTAC compound globally to enter the clinical stage.

The phase I trial is a randomized, double-blind, placebo-controlled, parallel group, dose escalation study to evaluate the safety, tolerability and pharmacokinetics of GT20029 following single ascending dose in healthy subjects and multiple ascending dose administration in subjects with AGA or acne.

In preclinical studies, by degrading androgen receptor protein, GT20029 can effectively block the shrinkage and miniaturization of hair follicles caused by activated AR signaling pathway. As the result, it prevented the hair from thinning, softening and falling out. GT20029 can effectively inhibit local androgenetic effects and avoid systemic exposure by limiting skin penetration, achieving good safety.

Dr. Youzhi Tong, founder, Chairman and Chief Executive Officer of Kintor Pharma, commented, "We are delighted to see the completion of the enrollment and dosing in the U.S. phase I trial of GT20029. Kintor Pharma is the first company globally to develop a topical AR-PROTAC compound, we have been actively exploring innovative drug strategies for the application of PROTAC technology to clinical topical treatment. As a PROTAC compound, GT20029 is expected to administer less frequently and more efficient to KX-826 to meet the needs of patients with different types of alopecia and acne. Alopecia affects about 1.6 billion people and acne affects about 0.72 billion people worldwide, with both indications having a huge unmet clinical need. By accelerating the clinical process of GT20029 and KX-826, we hope we can advance new and effective treatment options for patients with AGA and acne worldwide."

About GT20029

GT20029 is a topical androgen receptor (AR) degrader using Kintor Pharma's PROTAC platform. The China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) cleared GT20029's clinical trial application for treating AGA and acne in April 2021 and July 2021, respectively. In August 2022, Kintor Pharma has completed the enrollment and dosing of subjects for its China phase I clinical trial of GT20029. In February 2022, Kintor Pharma announced the dosing of first subject in its U.S. 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