Kintor Pharmaceutical Ltd (HKG: 9939), a clinical-stage biotechnology company, has announced that its Phase II clinical study for GT20029, a first-in-class proteolysis targeting chimera (PROTAC) compound, has met its primary endpoint in the treatment of male androgenetic alopecia (AGA) in China. The multi-center, randomized, double-blind, placebo-controlled study aimed to evaluate the efficacy and safety of the topical GT20029 drug and determine the recommended dosage for a Phase III study. Conducted across 12 centers in China, the trial enrolled 180 males, with the treatment group receiving doses of 0.5% and 1%.
Results indicated that GT20029 demonstrated statistically significant therapeutic advantages and clinical significance over placebo in both once-daily (QD) and twice-weekly (BIW) cohorts, with a dose-response relationship observed between different GT20029 dosage groups. The compound also exhibited a favorable safety and tolerability profile, with the incidence of adverse events during treatment comparable to placebo. The optimal dosage for the Phase II study was determined to be 1% BIW, which is recommended for the Phase III study in Chinese male AGA patients.
GT20029, hailed as the world’s first external-use PROTAC compound by Kintor, works by recruiting AR protein to E3 ubiquitin ligase for degradation, targeting local skin tissues and minimizing systemic drug exposure. This approach reduces the sensitivity of AR to androgens in local hair follicles and sebaceous glands. With two new drug application (NDA) currently under review by the National Medical Products Administration (NMPA), GT20029 represents a significant advancement in the treatment of AGA.- Flcube.com
