China-based Kintor Pharmaceutical Ltd (HKG: 9939) has announced the start of the long-term safety trial for KX-826, a potential first-in-class androgen receptor (AR) antagonist for the treatment of androgenetic alopecia (AGA). This in-house developed treatment has completed its first patient enrollment in China.
Phase III Clinical Trial Design and Objectives
The multi-center, open-label Phase III clinical trial involves 16 clinical research centers across China and aims to enroll 270 male and female AGA patients. The trial is designed to assess the long-term safety of the topical application of KX-826 for AGA patients over a 52-week treatment period. The primary endpoint will be the incidence of treatment emergent adverse events (TEAE). Secondary endpoints include efficacy评估, measured by the change in target area non-vellus hair count (TAHC) from baseline, along with other safety indicators.
Previous Success in Phase II Trials
Kintor Pharma has previously completed Phase II clinical trials for KX-826 in the treatment of AGA, including trials for male patients in China, female patients in China, and male patients in the United States. In each of these trials, after a 24-week administration, KX-826 demonstrated improved hair growth and a favorable safety profile. The majority of adverse events observed were mild and similar to those experienced with a placebo. There were no TEAEs that led to patient withdrawal from the trials, nor were there any reported deaths.-Fineline Info & Tech
