Kintor Pharmaceutical Limited, a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, announced that the company completed the enrollment of 121 patients for its phase II clinical trial of KX-826 (“pyrilutamide”) in the United States for the treatment of male androgenetic alopecia (AGA) patients on August 1, 2022.
The phase II trial (NCT05218642) in the US is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of KX-826 for the treatment of AGA in adult males. The primary endpoint for the trial is the change from baseline in non-vellus target area hair counts (TAHC) at week 24 in comparison to placebo.
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Dr. Youzhi Tong, founder, Chairman, and CEO of Kintor Pharma, commented, “About 83 million men and women in the US are suffering hair loss and the number in China has exceeded 252 million, hair loss is gradually becoming the focus of the whole society. As a topical AR antagonist, KX-826 has showed a good efficacy and safety profile in our phase II clinical trial in China for the treatment of AGA in male patients. We look forward to accelerating the clinical process of KX-826 to the benefit of those that suffer from hair loss.”
AGA, which is hair loss caused by excessive production of androgens, accounts for more than 90 percent of hair loss. The population of those who suffer from hair loss has a large number and tends to be younger, but there are few therapeutic options. Safer and more effective treatments are needed to address the concerns of men and women suffering from hair loss.
KX-826 is an androgen receptor (AR) antagonist and a potential first-in-class topical drug for the treatment of AGA and acne vulgaris. For the AGA indication, on 8 September 2021, Kintor Pharma announced that the primary endpoint of the phase II clinical trial of KX-826 on adult male patients was met, with results demonstrating a positive safety profile and good efficacy. Kintor Pharma now is conducting a phase III clinical trial of KX-826 in China and a phase II clinical trial of KX-826 in the US for male AGA patients. Kintor is also conducting a phase II clinical trial of KX-826 for female AGA patients in China. For the acne vulgaris indication, Kintor Pharma is conducting a phase II clinical trial of KX-826 in China for the treatment of acne vulgaris.