Kintor Pharma Receives IND Clearance by NMPA for KX-826's Pivotal Study to Treat Male Alopecia Patients
- Category: Small Molecules
- Published on Thursday, 25 November 2021 10:49
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SUZHOU, China I November 24, 2021 I Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that the IND application for the pivotal study (phase III stage) of pyrilutamide (KX-826), a potential first-in-class drug developed by Kintor Pharma, for the treatment of male androgenetic alopecia ("AGA") patients was cleared by the National Medical Products Administration ("NMPA"). KX-826 is the first androgen receptor (AR) antagonist which has entered the phase III clinical trial for AGA treatment in China and global.
The pivotal study is a randomized, double-blinded, placebo-controlled, multi-regional phase III clinical trial, which is designed to evaluate the efficacy and safety of KX-826 for treating male AGA patients in China. The sample size of the phase III clinical trial 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.
On 8 September 2021, Kintor Pharma announced that the primary endpoint of the phase II clinical trial of KX-826 on male AGA patients in China was well met, and KX-826 has demonstrated an outstanding efficacy and safety profile. The phase III clinical trial will be conducted in more than 20 sites (hospitals) in China. The principal investigators ("PIs") are Professor Zhang Jianzhong from Peking University People's Hospital and Director Yang Qinping from Huashan Hospital of Fudan University. Kintor Pharma expects the first patient enrollment to happen in early January 2022.
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, as results showed good efficacy and safety profile. On 11 July 2021, Kintor Pharma announced that the Food and Drug Administration of the United States greenlighted KX-826's phase II clinical trial for AGA to be conducted in the United States, and Kintor Pharma is preparing for the patients enrollment. For the acne vulgaris indication, the phase I clinical trial of KX-826 for the treatment of acne vulgaris has been completed, and Kintor Pharma is preparing for phase II clinical trial 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 cancer, alopecia, and acne. For more information, visit www.kintor.com.cn.
SOURCE: Kintor Pharma