Kintor Pharma Announces Completion of Patient Recruitment in Phase II Clinical Trial of KX-826 in China for the Treatment of Androgenetic Alopecia in Female Patients

SUZHOU, China, March 6, 2022 /PRNewswire/ — Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX:9939), a clinical-stage biotechnology company developing innovative small molecules and biologic therapies, today announced that the company has completed the recruitment of 160 patients for its phase II clinical trial of KX-826 (“pyrilutamide”) in China for the treatment of female androgenetic alopecia (AGA) on March 4, 2022, which has only taken about four months since launch.

The population of those who suffer from hair loss is large and tends to be younger, and hair loss is gradually becoming the focus of the whole society. At the end of 2020, the number of hair losses in China had exceeded 252 million. AGA, known as the most common type of hair loss, is a condition that can affect both men and women. In Chinathe prevalence of AGA is approximately 21.3% in men and 6.0% in women*.

dr. Youzhi TongFounder, President and CEO of Kintor Pharma said, “We are delighted to see the completion of all subject enrollment in the Phase II clinical trial of KX-826, and I would like to especially thank all investigators, subjects and my team who participated in this clinical trial. China, one in 20 adult women experience hair loss, and the ratio for adult men is 5:1. Hair loss has a significant impact on patients’ mental health and quality of life. We look forward to receiving preliminary data from this study in the fourth quarter of this year, further expanding the clinical potential of KX-826 in female AGA patients and accelerating the Phase III clinical trial of KX-826 for male AGA patients. in Chinain order to respond as soon as possible to the treatment needs of people suffering from hair loss.”

About the trial

The Phase II trial is a randomized, double-blind, placebo-controlled, multi-regional study to evaluate the efficacy and safety of KX-826 for the treatment of AGA in adult women (N=160). The primary endpoint of the trial is change from baseline in hair count in the target non-hairy area (TAHC) at week 24. Peking University People’s Hospital leads the trial, in which 15 hospitals are participating. Professor Zhang Jianzhong, Director of the Department of Dermatology, Peking University People’s Hospital and Chairman of the 13th Session of the Dermatology and Venereology Branch of the Chinese Medical Association, is the Principal Investigator (Principal PI) of the clinical trial of phase II of KX-826 for patients with AGA.

About the KX-826

KX-826 is an androgen receptor (AR) antagonist and a potential first-class topical drug for the treatment of AGA and acne vulgaris. For the AGA indication, on September 8, 2021, Kintor Pharma announced that the primary endpoint of the phase II clinical trial of KX-826 in adult male patients has been met, as the results showed a good efficacy and safety profile. . Kintor Pharma is currently conducting a Phase III clinical trial of KX-826 in China and a Phase II clinical trial of KX-826 in the United States for male AGA patients, and the completion of 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.

About Kintor Pharmaceutical Limited

Kintor Pharmaceutical Limited is developing and commercializing a strong portfolio of innovative small molecule and biologic therapies for androgen receptor-related diseases with unmet medical needs including COVID-19, prostate, breast and liver cancer, l alopecia and acne. For more information, visit www.kintor.com.cn.

* Guidelines for the diagnosis and treatment of androgenetic alopecia in China

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SOURCEKintor Pharma

Elna M. Lemons