China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced the conclusion of a randomized, double-blind, placebo-controlled Phase II clinical study for its drug candidate KX-826 (pyrilutamide) in the US for the treatment of male patients with androgenetic alopecia (AGA). The study demonstrated that KX-826 can promote hair growth, with statistically and clinically significant results measured by the number of non-vellus hairs (TAHC) in the target area compared to baseline.
KX-826 Exhibits Numerical Advantage and Dose-Effect Relationship
KX-826 showed a numerical advantage in TAHC changes compared to the placebo, indicating the drug’s potential efficacy in treating AGA. Additionally, a dose-effect relationship was observed across different dosage groups of KX-826, suggesting that the drug’s effectiveness may be influenced by the dosage. The study also reported good safety profiles for KX-826. With these positive results, Kintor Pharma has initiated preparations for communication meetings with the FDA and plans to conduct Phase III clinical trials in the United States and globally.
KX-826: A Potential First-in-Class Drug for AGA and Acne
KX-826 is a potential first-in-class drug under development for external use to treat AGA and acne. The drug has been subject to multiple clinical studies for both female and male AGA in China and the US. In December 2022, KX-826 reached the primary endpoint in a Phase II clinical study for female AGA in China. Furthermore, a Phase III study for the drug in male AGA completed patient enrollment in March 2023, with topline results expected to be announced during the fourth quarter of 2023.-Fineline Info & Tech
