View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. News
September 27, 2021

Kintor receives approval for Covid-19 trial of proxalutamide in Brazil

The multi-regional trial will evaluate the efficacy and safety of the therapy in 1,030 hospitalised Covid-19 patients.

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.

Related Companies

Free Whitepaper
img

Unlocking the clinical trial potential of Africa

Ongoing improvements around infrastructure, continued investment, and being home to one of the world’s largest working age populations, means that Africa’s role in the clinical trials market has transformed. In this whitepaper, Oximio outlines the dynamics of today’s clinical trial market in Africa, including the key challenges the region is facing and how sponsors can overcome them to unlock the continent’s growing potential.
by Oximio
Enter your details here to receive your free Whitepaper.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU