Suzhou, October 4 , 2021 — Kintor Pharmaceutical Limited (“Kintor Pharma”, HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, announced today that on October 1 its phase III clinical trial of proxalutamide for the treatment of hospitalized COVID-19 patients has enrolled and dosed its first patient in the United States. Proxalutamide is the only small-molecule oral drug which has entered the phase III MRCT clinical trial for treating hospitalized COVID-19 patients.

The phase III trial is a randomized, double-blind, placebo-controlled, multi-regional pivotal trial, designed to evaluate the efficacy and safety of proxalutamide in hospitalized COVID-19 patients. The primary endpoint for the trial is the time to sustained recovery evaluated by Day 30. The secondary endpoint of the trial 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 hospitalized COVID-19 patients has finished the first patient enrollment in the US. 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. This pivotal study has taken reference to the positive data on efficiency and safety profile of proxalutamide's treating hospitalized COVID-19 patients in the IIT study conducted in Brazil earlier this year. Meanwhile, according to our in-house research and collaborations with US and China's scientists, we are excited to find out that proxalutamide, as an AR antagonist and AR degrader, has demonstrationed 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 minimize 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.”