Appili Therapeutics has secured clearance from the US Food and Drug Administration (FDA) to expand the Phase II Covid-19 clinical trial of favipiravir to long-term care (LTC) facilities in the country.
The aim is to study the ability of the drug in controlling outbreaks after exposure to Covid-19 at these facilities.
Appili plans to recruit up to 760 participants for the Phase II study of favipiravir across the US and Canada. Health Canada granted clearance for the trial in May.
The company will assess the drug, which was originally developed by Fujifilm Toyama Chemical, as a preventative option against Covid-19 outbreaks.
Appili Therapeutics CEO Dr Armand Balboni said: “The burden of illness in long-term care centres continues to be a significant problem, and finding ways to offer LTC residents and staff protection against Covid-19 with an oral treatment would be a significant advance in our fight to control the devastating effects of this pandemic.
“The limited response to vaccines often seen in the elderly further supports expanding this trial into the US.”
Favipiravir is a oral medication that avoids the need for intravenous administration or injections. It is expected to help avoid and/or control outbreaks in elderly residents at LTC facilities.
Favipiravir holds approval in Japan, under the name Avigan, as a treatment and stockpile countermeasure for an influenza outbreak.
After promising data was reported in clinical studies, Russia and India approved favipiravir-based antiviral drugs for the emergency treatment of Covid-19.
Additional trials are being performed to assess the drug as a treatment for Covid-19 in other countries, including the US, Japan, China, and the UK.