FDA Clears Appili Therapeutics to Expand its Phase 2 Clinical Trial of Favipiravir for the Potential Prevention of COVID-19 at U.S. Long-Term Care Facilities
Appili Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to proceed after Appili’s filing of an investigational new drug (IND) application for broad-spectrum antiviral favipiravir. Appili is expanding its Phase 2 clinical trial into the U.S. to evaluate the safety and efficacy of favipiravir tablets in controlling outbreaks following exposure to COVID-19 in long-term care (LTC) facilities. Appili’s Phase 2 clinical trial is leveraging the versatility of favipiravir as an oral tablet suitable for administration across a wide variety of care settings, including long-term care. Appili intends to enroll up to 760 participants in this Phase 2 clinical trial across both the U.S. and in Canada. Health Canada provided regulatory clearance on May 21, 2020 for Appili’s Phase 2 study evaluating FUJIFILM Toyama Chemical’s (FFTC) favipiravir as a preventative measure against COVID-19 outbreaks.
“The burden of illness in long-term care centers 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,” said Dr. Armand Balboni, Chief Executive Officer at Appili Therapeutics. “The limited response to vaccines often seen in the elderly further supports expanding this trial into the U.S. Favipiravir is an antiviral that can be administered orally as a tablet, without the need to be given intravenously or as injections, and may be an important option to avoid and/or control outbreaks in elderly residents living in LTC facilities.”
“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 Primary Investigator Dr. 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 U.S. to understand if favipiravir could be an option for outbreak control in this setting.”
Favipiravir was originally developed and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza outbreak under the name AVIGAN. Following promising clinical studies, Russia and India recently approved favipiravir-based antiviral medications for the emergency treatment of COVID-19.ii iii Researchers are conducting additional trials evaluating favipiravir as a treatment for COVID-19 in countries including the United States, Japan, China, and the United Kingdom.
The Company is not making any express or implied claims that it has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time.