Glenmark Pharmaceuticals has reported that data from the Phase III trial of the oral antiviral medication, Favipiravir, showed significant improvement in time to clinical cure in patients with mild to moderate Covid-19.
The antiviral drug Favipiravir (FabiFlu) inhibits a viral enzyme called RNA dependent RNA polymerase (RdRP), thereby stopping the virus’ replication cycle.
The study titled ‘Efficacy and Safety of Favipiravir, an Oral RNADependent RNA Polymerase Inhibitor, in Mild-to-Moderate COVID-19: A Randomized, Comparative, Open-Label, Multicenter, Phase 3 Clinical Trial’ was conducted in 150 patients.
It analysed the efficacy and safety of Favipiravir plus standard supportive care (Favipiravir treatment arm), versus standard supportive care alone (control arm), in the patients.
The patients were given Favipiravir tablets 3,600mg on day one (1,800mg twice daily) and 1,600mg (800mg twice daily) on day two or later for up to a maximum of 14 days.
Data showed that the drug provided multiple treatment benefits including faster time to clinical cure and even delayed the need for supportive oxygen therapy.
Furthermore, Covid-19 patients with moderate symptoms were discharged from the hospital earlier than those who did not receive Favipiravir.
The median time to clinical cure was reduced by 2.5 days in the treatment arm versus the control arm.
Glenmark Pharmaceuticals chief commercial officer Robert Crockart said: “From the first reported case of Covid-19, our every effort was to bring a viable, safe and effective treatment option to patients in a timely manner.
“It is encouraging to see our trial results now published in a reputed global medical journal, which we hope will support other countries in their fight against this disease.”
In the trial, Favipiravir was observed to be well tolerated with no serious adverse events (SAEs) or deaths.
Time from randomisation to cessation of oral shedding of the virus, the trial’s pre-specified primary endpoint, showed two days early virological cure in Favipiravir arm, though not statistically significant.