China-based Kintor Pharmaceutical Ltd (HKG: 9939) announced that the Phase II clinical study for its AR antagonist KX-826 (pyrilutamide) in female patients with androgenetic alopecia (AGA) in China has reached the primary endpoint.
Study Design and Results
The randomized, double-blind, placebo-controlled, multicenter study, with 160 patients enrolled, is designed to assess the efficacy and safety of the drug in adult female AGA. The primary endpoint is the change in the number of non-vellus hairs in the target area compared to the baseline at 24 weeks of treatment. A total of 119 patients received different doses of pyrilutamide after randomization, and the other 41 patients were assigned to the placebo group. The results showed that the overall safety of each dose group of pyrilutamide was good, and it had significant efficacy; pyrilutamide 5mg (0.5% concentration) QD was determined as the recommended dosage in the phase III clinical trial of androgenic alopecia in Chinese adult women.
KX-826 Development and Future Plans
KX-826 is a potential first-in-class drug under development to treat AGA and acne for external use. The drug, subject to a Phase III study in male AGA in China, completed patient enrollment in Phase II study in the US and Phase II study in China in acne.-Fineline Info & Tech
