Kintor Pharmaceutical has reported top-line results from its investigator-initiated trial of Proxalutamide in Brazil, which showed a 92% reduction in mortality in hospitalised Covid-19 patients.
A nonsteroidal antiandrogen, Proxalutamide is being developed as the potential treatment for Covid-19, prostate cancer and breast cancer.
Carried out by Dr Andy Goren and Dr Flávio Adsuara Cadegiani, the placebo-controlled, double-blinded, randomised, parallel assignment, and multi-centre trial enrolled 588 patients within 48 hours of hospital admission.
The study had two cohorts (men and women) and two arms (Proxalutamide and control).
In the Proxalutamide arm, subjects received oral 300mg once-daily dose of Proxalutamide for 14 days, while those in the control arm received oral placebo once-daily for 14 days. Both arms were also given principal investigator-determined standard of care.
Treatment efficacy of Proxalutamide as compared with control assessed by the WHO Covid-19 ordinal scale on day 14 formed the trial’s primary endpoint.
On 9 March, a preliminary analysis was conducted based on 294 patients in the Proxalutamide arm and 296 patients in the control arm.
Results showed that the mortality in the Proxalutamide arm was 11 (3.7%) versus 141 (47.6%) in the control arm on day 14, indicating a 92% reduced mortality risk.
In the treatment arm, the number of new mechanical ventilation (MV) and/or death was 13 versus 156 in the control arm, lowering the mortality risk by 92%.
Furthermore, the median hospital length stay (days) in the treatment arm was five versus 14 in control.
Kintor Pharmaceutical founder, chairman and CEO Dr Tong Youzhi said: “This trial for treatment of hospitalised Covid-19 patients was conducted in 12 sites in the Brazilian state of Amazonas, where the pandemic has been devastating.
“Most of the newly test-positive patients in Amazonas have been infected by the new P.1 variant, which is more contagious and has led to a higher mortality rate.
“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.”
The trial enrolled 588 patients within 48 hours of hospital admission.