Topline results from a trial in Brazil show that treatment with Kintor’s proxalutamide cut mortality risk by 92% and significantly shortened the median length of hospital stay by nine days compared with standard of care in hospitalized patients with COVID-19.
Proxalutamide helped in decreasing the mortality risk.
Topline results from an investigator-initiated trial in Brazil show that treatment with Kintor Pharmaceutical’s proxalutamide cut mortality risk by 92% and significantly shortened the median length of hospital stay by nine days compared with standard of care in hospitalized patients with coronavirus disease 2019 (COVID-19).
Back in December, a preliminary analysis of the proxalutamide trial showed similar promising findings, with the hospitalization rate at 0.8% in the proxalutamide versus 27.0% in the control arm at the time of data cutoff.
The updated analysis of the placebo-controlled, randomized, multi-center study included 588 of a planned 600 patients who were admitted to the hospital with COVID-19 symptoms.
All patients scored a three, four, or five on the COVID-19 Ordinal Scale, which meant that patients were hospitalized and either required or didn’t require supplemental oxygen or ongoing medical care. None of the patients with these classifications required invasive mechanical ventilation, extracorporeal membrane oxygenation, non-invasive ventilation, or high-flow oxygen devices.
Patients in the proxalutamide arm received oral 300 mg proxalutamide once per day for a total of 14 days. The control arm consisted of once daily orally administered placebo for 14 days. All patients received standard of care, which was determined by each site’s principal investigator.
The primary endpoint of treatment efficacy was defined as a significant change in the World Health Organization’s COVID-19 ordinal scale on day 14.
Overall, Kintor’s preliminary analysis was based on 294 patients treated with proxalutamide arm versus 296 patients treated with standard-of-care control. On day 14, treatment with proxalutamide was associated with a 92% reduced mortality risk relative to placebo. The mortality rates were 3.7% in the proxalutamide arm versus 47.6% in the control group.
At day 14, the investigators found that treatment with proxalutamide, a nonsteroidal antiandrogen, was associated with a 4.01 reduction in the COVID-19 Ordinal Scale (5.663 at baseline vs. 1.653 at 14 days). In contrast, standard of care only was associated with a 0.25 reduction in the ordinal scale from baseline (5.618 to 5.368). A statistical analysis demonstrated proxalutamide was significantly better than standard of care alone for the reduction of scores on the ordinal scale.
Additionally, a greater proportion of patients in the control arm required new mechanical ventilation or died (52.7% vs. 4.4%). The median length of hospital stay was 5 and 14 days in the proxalutamide and control arms, respectively.
“This trial for treatment of hospitalized COVID-19 patients was conducted in 12 sites in the Brazilian state of Amazonas, where the pandemic has been devastating,” said Kintor’s Chairman and Chief Executive Officer Dr. Tong Youzhi, in a statement. “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.”
Earlier this month, the U.S. Food and Drug Administration approved an Investigational New Drug application for a U.S.-based Phase III clinical trial of proxalutamide in male outpatients with COVID-19. This approval marks the first China-based biopharmaceutical company whose novel, small-molecule candidate was granted Phase III trial approval by the agency.
