Kintor Pharmaceutical Limited is pleased to update the preliminary analysis of Proxalutamide's clinical trial for the treatment of COVID-19.
Proxalutamide is a new androgen receptor (AR) antagonist developed by Kintor Pharmaceutical and is currently undergoing phase I-III clinical trials in China and the US for the treatment of prostate cancer and breast cancer. Following the outbreak of COVID-19, the company found that Proxalutamide could limit the expression of ACE-2 and TMPRSS2, which plays a critical role for SARS-CoV-2 to bind and enter host cells in the lung.
The Clinical Trial is a randomized, double-blind, and placebo-controlled clinical trial, designed to explore the role of anti-androgen agents in the treatment of COVID-19. It is an investigator-initiated trial (IIT). The preliminary analysis included 319 enrolled subjects. The co-primary endpoints of the clinical trial are the percentage of subjects hospitalized with COVID-19 and the COVID-19 Ordinal Outcome Scale (a 7-point ordinal scale published by the World Health Organization, such as mechanical ventilation usage and death) in 30 days.
The preliminary outcome of the trial showed that the hospitalization rate was 0.8% for the Proxalutamide arm, compared to 27.0% for the control arm, the percentage of mechanical ventilation usage was 0% for the Proxalutamide arm versus 9.0% for the control arm, and the percentage of death was 0% for Proxalutamide arm versus 2.0% for the control arm. Both co-primary efficacy endpoints were achieved. The final clinical study report of the trial is expected in January 2021.
The table below is the comparison between the Proxalutamide arm and the control arm in terms of the percentage of positive in rtPCR test between day 0 and day 30 as of December 8, 2020. The Proxalutamide arm has shown a greater reduction of viral load starting from day 7, and this trend continued until the results of day 30. The rtPCR test, the so-called RT-PCR test, is a real-time reverse transcription-polymerase chain reaction test for the qualitative detection of nucleic acid from SARS-CoV-2, of which positive results are indicative of the presence of SARS-CoV-2 RNA.
Dr. Tong Youzhi, the founder, Chairman, and CEO of Kintor Pharmaceutical said, "Proxalutamide, as an AR antagonist, is used for the treatment of tumor and AR-related non-tumor diseases. We are glad to see the positive results in COVID-19 clinical trials with Proxalutamide, which is expected to reduce the probability of the progression from mild to severe in COVID-19 patients by lowering the expression of TMPRSS2 and ACE-2 proteins. We are actively initiating MRCT phase III clinical trials in countries such as the US and China, and hope to obtain an emergency use authorization (EUA), in this way more COVID-19 patients would benefit from Proxalutamide."