First Patient Enrollment in GT20029 China Phase II Trial for AGA
Suzhou, April 14, 2023 - Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, announced that the company has completed the first patient enrollment in Phase II clinical trial of its in-house developed first-in-class proteolysis targeting chimera (PROTAC) compound GT20029 in China for the treatment of male androgenetic alopecia (AGA). GT20029 is the world’s first topical PROTAC compound which entered the Phase II clinical stage.
The Phase II clinical trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of GT20029 for treating male AGA adults in China. Kintor Pharma plans to enroll a total of 180 male AGA patients from 12 centers nationwide. Professor Yang Qinping from Fudan University, Huashan Hospital is the leading principal investigator (leading PI) of this trial. The primary endpoint for this trial is the change from baseline in non-vellus target area hair counts (TAHC) after 12 weeks of treatment in comparison to placebo.
According to the epidemiological survey of the 2019 "Guidelines for the Diagnosis and Treatment of Chinese Androgenetic Alopecia", the prevalence of male AGA in China is 21.3%. The guidelines emphasize the importance of early and long-term treatment because AGA is a continuous progression to alopecia.
Dr. Youzhi Tong, founder, Chairman and Chief Executive Officer of Kintor Pharma, commented, “We are delighted to see the kickoff of GT20029 Phase II clinical trial in China. GT20029 has a unique mechanism of action that can effectively block the AR signaling pathway by degrading the AR protein. Kintor Pharma has completed the Phase I clinical trials of GT20029 both in China and the US, and the top-line data of more than 200 subjects have indicated that GT20029 has a good safety profile for multiple doses of topical application. As the world’s first company to develop topical PROTAC, we are looking forward that GT20029 could demonstrate the efficacy and further safety in Phase II clinical trial, maintaining the company’s leading position globally in developing novel drugs through in-house PROTAC platform, and paving the way for the company’s layout in the field of topical dermatology.”
About Kintor Pharmaceutical Limited
Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for oncology and androgen-receptor-related disease areas with unmet medical needs, including alopecia, acne, COVID-19, prostate cancer, liver and breast cancers. For more information, visit www.kintor.com.cn.
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