Treatment for androgenic alopecia.
Kintor Pharmaceutical Limited, a clinical-stage biotechnology company, announced the first dosing in its phase III clinical trial of KX-826 (pyrilutamide) in China for the treatment of male androgenetic alopecia (AGA) patients on December 31, 2021. KX-826 is the first androgen receptor (AR) antagonist that has entered the phase III clinical trial for AGA treatment in China and globally.
On November 24, 2021, Kintor Pharma announced that the China’s National Medical Products Administration (NMPA) greenlighted the protocol for the pivotal phase III study of KX-826.
On December 20, 2021, the kickoff meeting among key investigators for the KX-826 phase III clinical trial was successfully held. Peking University People’s Hospital and Huashan Hospital affiliated to Fudan University led the trial, with 26 hospitals to be participating. After successfully co-leading the phase II clinical trial of KX-826 in China for the treatment of AGA, Professor Zhang Jianzhong from Peking University People’s Hospital and Professor Yang Qinping from Huashan Hospital affiliated to Fudan University cooperate again to be the leading principal investigators (leading PIs) of the pivotal phase III Clinical Trial of KX-826. At the investigator meeting, nearly 100 experts from 26 hospitals across China listened to the report on the efficacy and safety of the KX-826’s Phase II clinical trial. Professor Zhang Jianzhong wrapped up the meeting and encouraged every PI to be engaged with this pivotal study with high quality and efficiency.
Dr. Youzhi Tong, founder, chairman, and chief executive officer of Kintor Pharma, commented, “Kintor’s team has executed with high efficiency from the NMPA’s clearance to the first dosing of this phase III clinical trial with around one month. This phase III clinical trial will be carried out in 26 top dermatology medical institutions across China. We look forward to completing the planned 416 subjects enrollment by June 2022, and the follow-up medical evaluation(6 months study + 1 month follow-up)within the year. With the goal of completing the phase III clinical trial this year, we are speeding up the process and expecting that KX-826 would benefit global patients as soon as possible.”
The pivotal study is a randomized, double-blind, placebo-controlled, multi-regional phase III clinical trial designed to evaluate the efficacy and safety of KX-826 for treating male AGA patients in China. The phase III sample size is 416, and the trial duration is 24 weeks. The primary endpoint is the change from baseline in non-vellus target area hair count (TAHC) at the end of week 24.
KX-826 is an androgen receptor (AR) antagonist and a potential first-in-class topical drug for the treatment of androgenetic alopecia (AGA) and acne vulgaris. For the AGA indication, on September 8, 2021, Kintor announced that the primary endpoint of the phase II clinical trial of KX-826 on adult male patients was met, as results showed good efficacy and safety profile. On November 12, 2021, Kintor announced the first patient dosing in its phase II clinical trial of KX-826 in China for the treatment of AGA female patients. On July 11, 2021, Kintor announced that the United States Food and Drug Administration greenlighted the KX-826’s phase II clinical trial for male AGA in the United States; Kintor Pharma currently is preparing for the patient enrollment. The phase I clinical trial of KX-826 for the treatment of acne vulgaris has been completed, and Kintor is preparing for the phase II clinical trial in China.