Kintor Pharma Announces Completion of Patient Enrollment in Phase II Clinical Trial of GT20029 for Treatment of Androgenetic Alopecia in China

22 Aug 2023
www.prnewswire.com
Phase 2Phase 1
SUZHOU, China, Aug. 22, 2023 /PRNewswire/ -- 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 enrollment of 180 patients for the 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 was developed based on the in-house PROTAC platform and is the world's first topical PROTAC compound which has 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 patients in China, and to determine the recommended dosage for the Phase III clinical trial. This trial involves a total of 12 clinical research centers in China, and Professor Yang Qinping from Fudan University Huashan Hospital is the leading principal investigator (leading PI). The primary endpoint of this trial is the change from baseline in non-vellus target area hair counts (TAHC) after 12 weeks of treatment in comparison to placebo.
Previously, 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 has demonstrated that GT20029 has a good safety profile and is well-tolerated for single and multiple doses of topical application.
Dr. Youzhi Tong, founder, Chairman and Chief Executive Officer of Kintor Pharma, commented, "We would like to thank all the PIs from the centers and the company's medical and clinical operation staffs for their joint efforts to finish the patients enrollment in the Phase II clinical trial of GT20029 in about four months. We expect to release the top-line data of the Phase II clinical trial in the first quarter of 2024, and look forward to collecting more efficacy and safety data of GT20029 in this trial. "
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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