Kintor begins Phase III trial of proxalutamide for COVID patients in US
pharmafile | October 5, 2021 | News story | Manufacturing and Production |
Chinese clinical-stage drug developer, Kintor Pharmaceutical Ltd, has announced the initiation of the Phase III clinical trial of proxalutamide for hospitalised COVID-19 patients in the US. The first patient has already been dosed, according to Global Banking and Finance.
Proxalutamide is a nonsteroidal antiandrogen that is under development for the potential treatment of COVID-19, among other diseases, including prostate cancer and breast cancer. Proxalutamide promotes the clearance of pathogens and decreases inflammation by activating the Nrf2 pathway, and reduces the intensity of the cytokine response, which would be of clinical benefit to patients with COVID-19.
Kintor’s Phase III trial is a randomised, double-blind, placebo-controlled study, which is expected to enrol 1,030 patients. The trial is designed to evaluate the efficacy and safety of proxalutamide in patients with COVID-19 who have been hospitalised. The primary endpoint of the trial is the time to sustained recovery evaluated by day 30, and the secondary endpoint is 30-day mortality.
Dr Youzhi Tong, founder, Chairman and Chief Executive Officer of Kintor Pharma, commented, “I am delighted to share the great news that the Phase III MRCT clinical trial of proxalutamide’s treating hospitalised COVID-19 patients has finished the first patient enrolment in the US.
“We are excited to find out that proxalutamide, as an AR antagonist and AR degrader, has demonstrated a clear mechanism of action including down-regulating ACE-2 and TMPRSS2 proteins, upgrading expression of NrF-2 and inhibiting IL-6 and TNF-alpha etc, thus minimising cytokine storms and tissues damage, which indicates proxalutamide as a possible therapy for severe COVID-19 patients. In this way, proxalutamide is well positioned to be an effective drug for COVID-19 patients from early symptoms to hospitalised.”
Brazil was the most recent country to approve the proxalutamide clinical trial, coming fourth after the US, China, and the Philippines. The study is currently seeking for approval by more regulatory agencies in Europe and Asia.
Lina Adams
