Biopharmaceutical major, Appili Therapeutics Inc., has reportedly announced that it has received the approval of the U.S. Food and Drug Administration (FDA) over its recently filed investigational new drug application for favipiravir, a broad-spectrum antiviral. The company has planned to expand the second phase of the clinical trials of this antiviral into the U.S., intending to evaluate the safety and efficacy of favipiravir tablets towards controlling outbreaks after exposure to COVID-19 in long-term care facilities.

According to Dr. Armand Balboni, the CEO of Appili Therapeutics, the burden of disease in long-term care facilities continues to be a major issue, and finding ways to provide LTC staff and residents with protection against COVID-19 via an oral treatment would be a remarkable milestone in efforts to contain the devastating effects of this pandemic. He has further highlighted that the limited response to the vaccine is frequently observed in elderly people and this has been the chief reason for expanding the trial into the U.S.

Also, favipiravir would be administered in the oral form as a tablet, without the requirement to be given in the intravenous mode, and might prove to be a significant option for avoiding and controlling outbreaks in elderly people living in LTC centers, added Balboni.

As reported, the company’s Phase 2 clinical trials focus on leveraging whether favipiravir could be suitably administered as an oral tablet across a broad range of long-term care settings. The company has planned to enroll up to 760 participants in this second phase of clinical trials across both Canada and the U.S.

Dr. Allison McGeer, Senior Clinician Scientist, Lunenfeld-Tanenbaum Research Institute, Sinai Health, has stated that, while the highest risk for contracting the disease lies with the elderly people, the currently surging rates of COVID-19 infection as evident in much of the U.S. are expected to be a major threat to people working and living in long-term care settings.

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https://www.businesswire.com/news/home/20200810005098/en/FDA-Clears-Appili-Therapeutics-Expand-Phase-2