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Phase II Clinical Trial Of GT20029 Gel For The Treatment Of Acne In China Reached Primary Endpoint

Release time：2025-08-12 13:20

Suzhou, 12 August, 2025-Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), announced that the Phase II Clinical Trial of its in-house developed androgen receptor (AR) proteolysis targeting chimera (PROTAC) compound GT20029 for the treatment of acne has read out the topline results. Results indicated that the Phase II Clinical Trial has successfully met the primary study endpoint with statistically significant and clinically meaningful outcomes, demonstrating excellent efficacy, safety and pharmacokinetics. The recommended dosage for the phase III clinical trial was determined to be 0.5%. Detailed topline data are expected to be released in academic journals or academic conferences in the future.

 

The Phase II Clinical Trial is a multi-center, randomized, double-blind, placebo-controlled study, which is designed to evaluate the efficacy, safety and pharmacokinetics of GT20029 for the treatment of acne through the adoption of GT20029 0.5% once-a-day (QD) and 1.0% QD as the drug-related dosage. The Phase II Clinical Trial involved a total of 10 clinical research  centers in China, and Professor Xiang Leihong (项蕾红) from Fudan University Huashan Hospital (复旦大学附属华山医院) is the lead principal investigator. The analysis results  demonstrated that:

 

Regarding efficacy, compared to the placebo group, in the total lesion counts (excluding nodules) category, the p value of 0.5% QD Group and 1.0% QD Group is 0.01 and 0.05, respectively. In the percent analysis of change in non-inflammatory lesion count from baseline, as compared to placebo, the p value of 0.5% QD Group and 1.0% QD Group is 0.14 and 0.09, respectively. In the percent analysis of change in inflammatory lesion count from baseline, as compared to placebo, both p value of 0.5% QD Group and 1.0% QD Group are lower than 0.01.

 

As compared to placebo group, in the success rate (according to the Investigator’s Global Assessment (IGA) Scale, a decrease in IGA score to 0-1 and a decrease of ≥ 2 levels is defined as success), the p value of 0.5% QD Group and 1.0% QD Group is 0.03 and 0.15, respectively.

 

In terms of safety, GT20029 gel exhibited satisfactory safety and tolerability in the clinical trial, with a low incidence of overall adverse events. The incidence of drug-related adverse events were comparable between 0.5% QD Group and 1.0% QD Group, which both are lower than that in the placebo group, with mild severity.

 

GT20029, as one of our core products, is developed in-house by the Company based on its own PROTAC platform and has the potential to become a new generation of treatment for androgenetic alopecia and acne vulgaris. It, as always, has remained in a leading position since its development and is the world’s first topical PROTAC compound that has completed phase II clinical trial. We are formulating future clinical strategies for GT20029 for the treatment of  acne, including initiating a phase III clinical trial in China for the treatment of acne, to further expand our first-mover advantage in topical PROTAC.

 

Winlevi® (clascoterone 1%, cream) is the first acne drug with a new mechanism of action (MOA) approved by the U.S. Food and Drug Administration (FDA) in the past 40 years to treat acne vulgaris in patients of 12 years of age and older. According to Cosmo Pharmaceuticals N.V.’s public disclosure, Winlevi® has become the most prescribed branded topical acne drug in the U.S. market, with over 1.3 million prescriptions written by more than 17,900 prescribers since its launch. The approval of an acne drug targeting AR demonstrates that the MOA of treating acne by blocking or degrading the AR signaling pathway has been validated. GT20029 is expected to provide dermatologists and patients with an innovative, safe and effective new treatment option.

 

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