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February 14, 2022

Kintor doses first subject in Phase III Covid-19 therapy trial in China

The trial will analyse the safety and efficacy of proxalutamide in male outpatients with Covid-19.

Kintor Pharmaceutical has enrolled and dosed the first participant in China in its multi-regional Phase III clinical trial of proxalutamide to treat Covid-19 outpatients.

The first subject was dosed at the Third People’s Hospital of Shenzhen in the country.

A nonsteroidal antiandrogen, proxalutamide is a selective high-affinity silent antagonist of the androgen receptor being developed to treat Covid-19, breast cancer and prostate cancer. 

It acts on the AR-ACE2/TMPRSS2 signal axis to hinder the viral entry into host cells. 

The randomised, double-blind, placebo-controlled, multi-regional trial will analyse the safety and efficacy of proxalutamide in male outpatients with Covid-19. 

It has so far enrolled approximately 200 subjects in trial centres in countries such as the Philippines, Brazil and Malaysia. 

Last September, the company obtained approval from the China National Medical Products Administration (NMPA) to carry out this trial. 

Apart from the Third People’s Hospital of Shenzhen, the trial centres in China include Beijing Ditan Hospital, Shanghai Public Health Clinical Center, China-Japan Friendship Hospital, the Public Health Clinical Center of Chengdu, the Fifth People’s Hospital of Suzhou and Hangzhou Xixi Hospital.

Kintor Pharma founder, chairman and CEO Dr Tong Youzhi said: “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 enrolment 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. 

“Besides, the clinical trial for Covid-19 inpatients has initiated the enrolment of patients in the US, Ukraine and the Philippines and is currently conducting patients screening before enrolment in sites in China.”

The latest development comes after Kintor dosed the first subject in a US Phase I trial of GT20029 (gel) to treat androgenetic alopecia and acne.

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