China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced positive results from a Phase I clinical study in China for its GT20029, which is being developed to treat androgenetic alopecia and acne. The study demonstrated that GT20029 has a good safety, tolerability, and pharmacokinetics profile.
Study Details
The randomized, double-blind, placebo-controlled Phase I study was designed to assess the safety and pharmacokinetics of GT20029 (gel/tincture) in healthy subjects via single or multiple doses of topical administration. The results showed that GT20029 was safe and well-tolerated, with low levels of human drug concentration. After a single administration, no drug exposure was detected in any subjects. After 14 consecutive days of administration, the mean maximum plasma drug concentration in each dose group was below 0.05ng/mL. No treatment-related adverse events (TRAE) above level 1 occurred during the study. Based on these results, Kintor Pharma will determine the dose for the Phase II study and initiate the corresponding clinical trials as soon as possible.
GT20029 Profile
GT20029 is described by Kintor as the world’s first external use compound based on proteolytic targeting chimera (PROTAC) technology. Excessive activation of the androgen receptor (AR) pathway is a key factor in the pathogenesis of androgenetic alopecia and acne. GT20029 can effectively block the androgen receptor signaling pathway by degrading the androgen receptor protein, thereby reducing systemic drug exposure and avoiding the side effects associated with oral therapeutic drugs. The drug has previously obtained clinical study approval in the US and China, with the first patient dosed in China in July 2021. All patient dosing in a Phase I study in the US was completed in October this year.-Fineline Info & Tech
