Appili receives FDA approval to test drug that could prevent COVID-19 spread at long-term care facilities

Clinical trial

Halifax-based Appili Therapeutics, which is developing and commercializing anti-infective drugs, has received clearance from the United States Food and Drug Administration (FDA) to expand the second phase of its trial testing a drug that could help to curb the spread of COVID-19 in long-term care facilities.

“The limited response to vaccines often seen in the elderly further supports expanding this trial into the US.”
– Armand Balboni, Appili Therapeutics

The drug, called favipiravir, is an antiviral that can be delivered orally in a tablet form, without the need to be administered through injections. Appili is now expanding the second phase of its clinical trial into the US to assess the safety and effectiveness of favipiravir in controlling outbreaks of COVID-19 in long-term care facilities.

In May, Appili received approval from Health Canada for the second phase of its study. Now, with US clearance, Appili intends to enroll up to 760 participants in Phase 2 of this clinical trial across both the US and Canada.

“The burden of illness in long-term care centers continues to be a significant problem, and finding ways to offer LTC [long term care] 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,” said Armand Balboni, CEO of Appili Therapeutics. “The limited response to vaccines often seen in the elderly further supports expanding this trial into the US.”

Appili Therapeutics develops drugs and advances therapeutics in the area of infectious disease. Instead of focusing on a select few drugs, Appili develops a portfolio of anti-infective programs before pursuing commercialization with strategic partners. Appili was founded in 2015 and began trading on the Toronto Stock Exchange at the end of June 2019. The startup closed a public offering at $10.25 million in February.

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Favipiravir was originally developed and approved in Japan as a therapy and countermeasure for the pandemic influenza outbreak. Following clinical studies, Russia and India also recently approved favipiravir-based medications for the emergency treatment of COVID-19. Researchers are also conducting trials assessing favipiravir as a potential treatment for COVID-19 in the US, Japan, China, and the United Kingdom.

“The elderly are at the highest risk for contracting the disease and the rising rates of COVID-19 infection currently seen in much of the U.S. will likely continue to be a major threat to those living and working in long-term care facilities,” said Allison McGeer, senior clinician-scientist at the Lunenfeld-Tanenbaum Research Institute at Sinai Health.

“Through the means of a randomized control clinical trial, our team is looking forward to working with clinical partners in the US to understand if favipiravir could be an option for outbreak control in this setting,” McGeer added.

Image source Unsplash. Photo by National Cancer Institute.

Isabelle Kirkwood

Isabelle Kirkwood

Writer, globetrotter, drone pilot & David Attenborough enthusiast