The clearance for the phase 2 preventive trial will seek the oral antiviral's benefit in elderly care facilities.
The US Food and Drug Administration (FDA) has granted clearance to an investigational new drug (IND) application for broad-spectrum antiviral therapy favipiravir, from Appili Therapeutics.
The clearance grants Appili the ability to proceed with an expanded phase 2 clinical trial into the US, evaluating the safety and efficacy of the antiviral tablets for the control of coronavirus 2019 (COVID-19) outbreaks in long-term care facilities.
The biopharmaceutical company is currently seeking the understood benefit of favipiravir for administration across a variety of clinical care settings, with intention to enroll up to 760 participants in the phase 2 trial occurring across the US and Canada.
The Canada-based assessment was originally approved by national regulators on May 21, seeking assessment of favipiravir as a prophylaxis against COVID-19 outbreaks.
Favipiravir is a Japan-based therapy that was developed and regulated for stockpile countermeasure prevention of pandemic influenza outbreak under the branded name of AVIGAN.
Countries including Russia and India have already approved favipiravir-based antiviral therapies for the emergency treatment of COVID-19, and investigators are continuing to assess the treatment in regions including the US, UK, Japan, and China.
As an orally-administered antiviral therapy, favipiravir may serve as a valuable option for the avoidance or control of outbreaks in elderly residents living in long-term care facilities—a clinical setting among the most burdened by the pandemic, primary investigator Allison McGeer, MD, said.
“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 US will likely continue to be a major threat to those living and working in long-term care facilities,” said McGeer, senior clinician scientist at the Lunenfeld-Tanenbaum Research Institute at Mount Sinai Health, in a statement.
Its role may be particularly pronounced as vaccine candidates come nearer to regulatory approval: at-risk elderly populations do not always benefit significantly from prophylaxes.
“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,” Armand Balboni, MD, PhD, chief executive officer of Appili, said. “The limited response to vaccines often seen in the elderly further supports expanding this trial into the US.”