Romark has reported that initial results from a Phase III clinical trial of its investigational new drug candidate NT-300 (nitazoxanide extended-release tablets, 300mg) demonstrated to reduce disease progression in mild or moderate Covid-19 patients.
NT-300 is an oral, broad-spectrum antiviral drug designed to provide antiviral concentrations of drug to the respiratory tract throughout twice-daily dosing.
The multicentre, randomised, double-blind trial had 1,092 subjects aged 12 years and above with respiratory symptoms consistent with Covid-19.
They were enrolled at outpatient centres in the US within 72 hours of symptom onset and received either two NT-300 tablets or placebo twice daily for five days.
Data showed that in the primary endpoint analysis, the median time to sustained response, a measure of recovery time, was comparable for participants receiving NT-300 versus placebo.
In pre-defined subgroup of patients with mild Covid-19 patients, the time to sustained response was 10.3 days in NT-300 treatment group as against 13.4 days in the placebo group.
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The analysis of the key secondary endpoint showed that NT-300 was linked to an 85% reduction in the disease progression to severe Covid-19.
Furthermore, in the pre-defined subgroup at high risk of severe illness according to CDC criteria, 5.6% of subjects in the placebo group developed severe illness versus 0.9% in NT-300-treatment group.
NT-300 was demonstrated to be well tolerated in the trial with no significant differences in adverse events between both groups.
Romark chief medical and scientific officer Jean-François Rossignol said: “Given the enormous toll of the Covid-19 pandemic and the continued public health risk, we are pleased that these clinical trial results show a compelling reduction in progression to severe Covid-19 with early NT-300 treatment.
“Along with vaccines and treatments for severe illness, oral treatments that can be administered outside of a hospital setting to effectively reduce disease progression are urgently needed.
The company intends to submit an application to the US Food and Drug Administration for Emergency Use Authorization for the drug.