Non-Steroidal Anti-Androgen Drug Demonstrates 92% Reduction in Mortality in Hospitalized COVID-19 Patients

Kintor Pharmaceuticals (Jiangsu, China) announced top-line results from its investigator-initiated trial evaluating the efficacy of Proxalutamide relative to standard of care as assessed by the COVID-19 ordinal scale. Proxalutamide is a non-steroidal anti-androgen - specifically, a selective high-affinity silent antagonist of the androgen receptor - which is under development for the potential treatment of COVID-19, prostate cancer, and breast cancer.

The investigator-initiated trial is a placebo-controlled, double-blinded randomized parallel assignment and multi-center study. The trial has two cohorts (men and women) and two arms (Proxalutamide and control). It enrolled 588 patients who met the eligibility criteria within 48 hours of admission to hospital. In the Proxalutamide arm, patients were orally administered Proxalutamide 300mg once daily (QD) for 14 days. In the control arm, patients were orally administered placebo once daily (QD) for 14 days. Each arm also received standard of care as determined by the principal investigator at the site. The primary endpoint of the trial is the treatment efficacy of Proxalutamide relative to control, as assessed by the WHO COVID-19 ordinal scale on day 14.

The preliminary analysis conducted on March 9, 2021 was based on 294 patients (56.8% male) in the Proxalutamide arm and 296 patients (57.8% male) in the control arm. According to the results on day 14, the mortality in Proxalutamide arm was 11(3.7%), compared to 141 (47.6%) in control arm, demonstrating a reduced mortality risk of 92%. The number of new mechanical ventilation (MV) and/or death in Proxalutamide arm was 13 (4.4%), compared to 156 (52.7%) in control arm, reducing mortality risk by 92%; and median hospital length stay (days) in Proxalutamide arm was 5, while it was 14 in control arm, which means Proxalutamide shortened hospital stay by 9 days.

"We are delighted to see that Proxalutamide could significantly reduce the mortality rate, shorten the length of hospital stay, reduce the number of new mechanical ventilations (MV), and increase the percentage of discharge from hospital, thus alleviating shortages of public health resources in Amazonas," said Dr. Tong Youzhi, Founder, Chairman and Chief Executive Officer of Kintor Pharmaceutical. "Based on the positive results of this phase 3 trial, the treatment of COVID-19 outpatients, hospitalized patients (including those admitted to Intensive Care Units), we expect Proxalutamide could become an important tool in the global fight against COVID-19."

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