The Food and Drug Administration has cleared the way for a phase 2 trial of favipiravir, an oral RNA antiviral, as a COVID-19 treatment in long-term care settings.
Developer Appili Therapeutics says it will test the drug’s efficacy and safety in controlling outbreaks following COVID-19 exposure. It is planning to enroll up to 760 eldercare facility staff members and residents across the United States and Canada. The company is working with Sinai Health to identify trial sites in Canada and will announce its U.S. partner shortly, CEO Armand Balboni, M.D., told McKnight’s.
An antiviral could have some advantages for older adults when compared with other treatments and preventatives, and an oral medication in particular could prove to be practical for the long-term care setting, Balboni said.
“The limited response to vaccines often seen in the elderly further supports expanding this trial into the U.S.,” he said. “We are initially looking specifically at favipiravir controlling outbreaks in ‘hot spots’ — in this case, long-term care centers.”
Remdesivir, another antiviral that in May was granted emergency approval to treat COVID-19 in the United States, has had success in hastening recovery in moderate cases of the disease. Unlike favipiravir, it is given intravenously.
“[F]inding 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,” Balboni said.
RNA antivirals target the proteins that help a virus infect other cells. They are typically administered as a course over several days. Favipiravir likely will be most successful when given as early as possible after an initial infection, Balboni said.
Originally developed by FujiFilm Toyama Chemical, favipiravir is approximately 10 years old and was approved and stockpiled in Japan as a pandemic flu drug. It also recently has been approved in India and Russia for emergency use against COVID-19, Balboni told McKnight’s.