Kintor Pharmaceutical Limited, a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, announced that the company has initiated the long-term safety trial of KX-826, a potential first-in-class androgen receptor (AR) antagonist for the treatment of androgenetic alopecia (AGA) developed in-house, in China and has completed the first patient enrollment. The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023.
The Long-term Safety Trial is a multi-center, open-label Phase III clinical trial, which involves a total of 16 clinical research centers in China, with Professor Jianzhong Zhang of Peking University People's Hospital as the leading principal investigator (leading PI). A total of 270 male and female AGA patients will be enrolled to evaluate the long-term safety of the topical use of KX-826 for the treatment of AGA patients in China (treatment period of 52 weeks). The primary endpoint of the trial is the incidence of treatment-emergent adverse events (TEAE). Secondary endpoints include efficacy as measured by the change in target area non-vellus hair count (TAHC) from baseline and other safety indicators.
Previously, Kintor Pharma has successfully completed the Phase II clinical trial for male in China, the Phase II clinical trial for female in China and the Phase II clinical trial for male in the United States for KX-826 in the treatment of AGA. In each trial, after 24-week administration, KX-826 improved hair growth and showed a good safety profile. Most of the adverse events occurred during the study were mild, and similar to placebo, no TEAE resulting in patient withdrawal from the trial, nor death was reported. The Long-term Safety Trial will further explore the long-term safety and efficacy of KX-826 in the treatment of AGA on the basis of the safety profile and efficacy of the above-mentioned trials, which will help provide more data to support the use of such medication for long-term treatment for AGA patients.
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