SUZHOU, China, March 28, 2023 /PRNewswire/ — Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, 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.
Dr. Youzhi Tong, founder, Chairman and Chief Executive Officer of Kintor Pharma, commented, “We would like to thank all the PIs from 26 centers and the company’s medical and clinical operations staff for their joint efforts to finish the subjects enrollment under the challenges of COVID-19 pandemic. This is another important milestone we have achieved following that the Phase II trials of KX-826 for male and female AGA in China have reached the primary endpoints, respectively. The company will continue to move forward the execution of 24-week study plus 4-week safety follow-up assessment with high quality, and expect to release the top-line data in Q4 2023. If the data is positive, we would proceed with the NDA application with the China NMPA. Meanwhile, the company is planning for KX-826’s MRCT studies and actively pursuing licensing-out opportunities. We believe that KX-826 would benefit hair loss people around the globe.”
About Androgenetic alopecia
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.
About Kintor Pharmaceutical Limited
Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancers, alopecia and acne. For more information, visit www.kintor.com.cn.