The trial is approved by the US FDA and ANVISA and is seeking approval from regulatory agencies in Europe and Asia.
Kintor Pharmaceutical has dosed the first subject in the US for the Phase III clinical trial of its oral drug, proxalutamide, to treat hospitalised Covid-19 patients.
Proxalutamide is a selective high-affinity silent antagonist of the androgen receptor, which is currently being developed to treat Covid-19, breast cancer and prostate cancer.
It is claimed to be the only small-molecule oral drug that has entered the Phase III multi-regional clinical trial (MRCT).
The randomised, double-blind, placebo-controlled, multi-regional pivotal trial has also been approved by the US Food and Drug Administration (FDA).
The study will assess the efficacy and safety of proxalutamide in hospitalised patients. Time to sustained recovery evaluated by day 30 will be the primary endpoint, while the 30-day mortality will be the secondary endpoint.
Kintor Pharmaceutical chairman and CEO Youzhi Tong said: “More than 100 sites in 14 countries participate in this MRCT clinical trial, which has been greenlighted/approved by the US FDA, China CDE, Philippines FDA and Brazilian ANVISA, and we continue to seek for approvals by regulatory agencies in European and Asian countries.
