Kintor Pharmaceutical has reported top-line data from Phase III multi-regional clinical trial (MRCT), where its proxalutamide substantially lowered hospitalisation or mortality in outpatients with mild-to-moderate Covid-19.
An inhibitor of angiotensin-converting enzyme 2 (ACE2) and transmembrane protease, serine 2 (TMPRSS2) proteins, proxalutamide hinders the SARS-CoV-2 virus’ entry into host cells.
The multicentre, double-blind, randomised, placebo-controlled, registrational trial assessed the safety and efficacy of proxalutamide against mild-to-moderate Covid-19 in the outpatient setting.
It had 733 male and female subjects with 99% of them enrolled at various US centres, irrespective of the status of their vaccination and risk factors.
These patients were given either a once-a-day dose of 200mg proxalutamide or a placebo, along with the standard of care (SOC) in both arms, for 14 days.
Trial findings showed that proxalutamide treatment for more than seven days offered a 100% protection rate in trial subjects.
Furthermore, proxalutamide substantially lowered hospital admission or morality in Covid-19 patients, especially in those who were middle-aged and elderly with increased risk factors.
In the proxalutamide arm, substantially and continuously lowered SARS-CoV-2 viral load from day three to 28 were reported versus placebo.
Symptoms of Covid-19 including fever, shortness of breath and cough improved by day 28 following treatment with proxalutamide versus those in the control arm.
In addition, proxalutamide was demonstrated to be well tolerated with side effects observed to be manageable in mild-to-moderate Covid-19 patients.
Kintor Pharma founder, chairman and CEO Dr Tong Youzhi said: “It is important to note that proxalutamide has showed Covid-19 viral load reduction against both Delta and Omicron variants, which is important as new variants continue to arise.
“Kintor plans to actively apply for emergency use authorization (EUA)/emergency approvals from healthcare authorities in China, the United States, and other countries.”
In February this year, the company enrolled and dosed the first subject in its Phase III trial of proxalutamide to treat Covid-19 outpatients in China.