Kintor Pharmaceutical has obtained approval from the Brazilian Health Regulatory Agency (ANVISA) to conduct the Phase III clinical trial of proxalutamide for the treatment of hospitalised Covid-19 patients.
A nonsteroidal antiandrogen, proxalutamide is a selective high-affinity silent antagonist of the androgen receptor being developed for treating Covid-19, prostate cancer, and breast cancer.
Kintor noted that this Phase III trial is the third ANVISA-approved pivotal study funded by the company to treat Covid-19 patients with proxalutamide.
The randomised, double-blind, placebo-controlled, multi-regional phase III trial will assess the efficacy and safety of proxalutamide in hospitalised Covid-19 patients.
It plans to enrol a total of 1,030 subjects.
The time to sustained recovery as assessed by day 30 will be the primary goal of the trial while 30-day mortality will be the secondary endpoint.
Kintor Pharmaceutical founder, chairman and CEO Dr Youzhi Tong said: “We have been planning to conduct the pivotal multi-regional clinical trial of proxalutamide for the treatment of hospitalised Covid-19 patients in more than ten countries.
“With this third approval by ANVISA, Brazil becomes the fourth country to approve the proxalutamide clinical trial after the US, China and Philippines.
“We are hopeful this approval will pave the way for Kintor Pharma to apply for an emergency use authorization (EUA) and the eventual commercialisation of proxalutamide for the treatment of Covid-19 in Brazil.”
Kintor enrolled and dosed the first subject in the Phase III trial of proxalutamide for treating male patients with mild or moderate Covid-19 symptoms, in the US, in April 2021.
In March, Kintor reported top-line results from its investigator-initiated trial of proxalutamide in Brazil, which showed a 92% reduction in mortality in hospitalised Covid-19 patients.