China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced positive topline data from a Phase I clinical study in the United States for its GT20029, a treatment for androgenetic alopecia (AGA) and acne. This marks a significant step in the development of a novel treatment option for these common conditions.
Phase I Study Design and Results
The randomized, double-blind, placebo-controlled, parallel-designed Phase I study was designed to assess the safety, tolerability, and pharmacokinetics of GT20029 (gel/tincture) in healthy subjects via single or multiple doses of topical administration. The study enrolled 123 subjects and showed a good safety and tolerability profile.
In the dosage escalation phase, for single-dose administration, subjects in all dose groups did not find any drug exposure in vivo, and the concentration of all samples was lower than the lower limit of quantification (“LLOQ”, 0.003ng/mL). For multi-dose administration, after 14 consecutive days of administration in AGA and acne, the systemic drug exposure in vivo was limited. The average peak concentration (“Cmax”) of each dose group fluctuated near the lower limit of quantification, with the maximum not exceeding 0.015ng/mL.
GT20029: First External-Use PROTAC Compound
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 and its physiological functions by degrading the androgen receptor protein. This mechanism allows the drug to exert local therapeutic effects while effectively reducing systemic drug exposure and avoiding the side effects associated with oral therapeutic drugs.
Previous Study Results
A Phase I clinical study for the drug in China, published in November last year, also showed that GT20029 had a good safety, tolerability, and pharmacokinetics profile. These consistent results across studies further validate the potential of GT20029 as a safe and effective treatment for AGA and acne.-Fineline Info & Tech
