Kintor Pharmaceutical Limited a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, today announced the enrollment and dosing of first patient in China in its multi-regional phase III clinical trial (NCT04869228) of proxalutamide for the treatment of COVID-19 outpatients in the Third People's Hospital of Shenzhen in China on 10 February 2022.

The phase III trial is a randomized, double-blind, placebo-controlled, multi-regional study, designed to evaluate the efficacy and safety of proxalutamide in male COVID-19 outpatients. The phase III trial has enrolled nearly 200 patients in sites in the countries including Brazil, the Philippines and Malaysia. China is one of the key countries participating in this multi-regional trial, which was approved by the China NMPA on September 1, 2021. The sites that participate in this trial in China include Beijing Ditan Hospital, China-Japan Friendship Hospital, the Third People's Hospital of Shenzhen, Shanghai Public Health Clinical Center, Hangzhou Xixi Hospital, the Public Health Clinical Center of Chengdu and the Fifth People's Hospital of Suzhou.

Dr. Tong Youzhi, the founder, Chairman, and CEO of Kintor Pharma, commented, "We would like to give special thanks to President Dr. Hongzhou Lu and his team in the Third People's Hospital of Shenzhen for the first patient enrollment and dosing in proxalutamide's phase III clinical trial for treating COVID-19 outpatients in China, which is a very important step for this multi-regional clinical trial. We will make every effort to invite more sites in China to join this pivotal study. Besides, the clinical trial for COVID-19 inpatients (NCT05009732) has initiated the enrollment of patients in the United States, Ukraine and the Philippines, and is currently conducting patients screening before enrollment in sites in China. We are also actively carrying forward the process in the rest of countries participating in our multi-regional clinical trials."

About Proxalutamide

Proxalutamide is a nonsteroidal antiandrogen — specifically, a selective high-affinity silent antagonist of the androgen receptor — that is under development for the potential treatment of COVID-19, prostate cancer, and breast cancer. Targeting AR-ACE2/TMPRSS2 signal axis by proxalutamide could significantly inhibit the entry of the virus into host cells by transcriptionally down-regulating the expression of TMRPSS2 and ACE2. Proxalutamide promotes the clearance of pathogens and decreases inflammation by activating the Nrf2 pathway, which inhibits the over production of IL-6, proinflammatory cytokines, and chemokines. This mechanism of action reduces the intensity of the cytokine response, which may be of clinical benefit to patients with COVID-19 infection.