Suzhou Kintor Pharma a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, today announced the dosing of first subject in its U.S. phase I clinical trial of GT20029 (gel) for the treatment of androgenetic alopecia (AGA) and acne on 1 February 2022, US local time. Developed through Kintor'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. Dr. Youzhi Tong, founder, Chairman and Chief Executive Officer of Kintor Pharma, commented, "The start of this US clinical trial represents a significant milestone for Kintor, as it demonstrates the beginning of the international development of the company's fourth innovative drug. In preclinical studies, we found that GT20029 can effectively block the androgen receptor pathway and its physiological function by degrading the AR protein. By limiting skin penetration, GT20029 inhibits local androgenic effects in peripheral skin tissues and so achieve good safety. Kintor is the first company globally to develop a topical AR-PROTAC compound. Pushing on accelerating the clinical evaluation of GT20029's safety, recommended dosage, and dosing frequency, we hope we can not only advance a new and effective treatment option for hundreds of millions of patients with AGA and acne worldwide, but also provide a successful case for the application of PROTAC technology to drug targets on local surfaces." About GT20029 GT20029 is an a topical androgenreceptor (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. According to preclinical studies, the efficacy of GT20029 appears superior to other small molecule AR inhibitors. In addition, topical GT20029 has also been shown to avoid systemic exposure and many of the side effects of oral androgen signaling pathway inhibitors. The China Center for Drug Evaluation (CDE) and the US Food and Drug Administration (FDA) cleared GT20029's phase I 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.
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