Kintor Pharmaceutical Limited announced that the company has completed the enrollment of 740 subjects recently for the Phase III clinical trial of its in-house developed first-in-class drug candidate KX-826 (pyrilutamide) in China for the treatment of male androgenetic alopecia (AGA) adults. The Phase III clinical trial is a randomized, double-blind, placebo-controlled, multi-regional study designed to evaluate the efficacy and safety of 5mg (0.5% concentration) twice daily (BID) KX-826 for treating male AGA adults in China. Professor Zhang Jianzhong from Peking University People's Hospital and Professor Yang Qinping from Huashan Hospital Affiliated to Fudan University are the leading principal investigators (leading PIs) of this trial.

The primary endpoint for the clinical trial is the change from baseline in non-vellus target area hair counts (TAHC) after 24 weeks of treatment in comparison to placebo. The safety endpoints mainly include the type, incidence and severity of adverse events. On 8 September 2021, the company announced that the primary endpoint of Phase II clinical trial of KX-826 for male AGA adults in China was met.

After 24 weeks of treatment, the TAHC in the 5mg (0.5% concentration) BID KX-826 group increased by 15.34/cm2 compared with the placebo group from baseline, with a statistical difference (P=0.024). On 1 December 2022, the company announced that the primary endpoint of Phase II clinical trial of KX-826 for female AGA adults in China was met. After 24 weeks of treatment, the TAHC in the 5 mg (0.5% concentration) once daily (QD) KX-826 group increased by 11.39/cm2 compared with the placebo group from baseline, with a statistical difference (P=0.0087).

KX-826 has showed a good safety profile in both trials. In addition, the Phase II clinical trial of KX-826 for the treatment of male AGA adults in the US has completed the enrollment of all subjects in August 2022, and the company expects to release the top-line data in the second quarter of 2023. Androgenetic alopecia (AGA), caused by excessive secretion of androgens, is the most common type of hair loss, accounting for about 90% of overall hair loss.

It is estimated that one in four male adults and one in twenty female adults suffer from hair loss. The existing treatment drugs are limited, and the majority of people with hair loss urgently need more safe and effective innovative drugs to address the hair loss trouble. 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 male adults was met, with results demonstrating a positive efficacy and safety profile. On 1 December 2022, Kintor Pharma announced that the primary endpoint of Phase II clinical trial of KX-826 for female AGA adults in China was met. Kintor Pharma has completed the enrollment of all subjects in its Phase III clinical trial of KX-826 in China and Phase II clinical trial of KX-826 in the US for male AGA adults.

For the acne vulgaris indication, Kintor Pharma has completed the enrollment of subjects in its Phase II clinical trial of KX-826 in China.