Appili Therapeutics has secured regulatory clearance from Health Canada to move ahead with a phase 2 study for studying FUJIFILM Toyama Chemical’s favipiravir as a preventative measure against the outbreak of novel coronavirus (Covid-19).
The Canadian biopharma company expects to immediately begin recruitment for the mid-stage trial of favipiravir with an aim to enroll nearly 760 subjects from both residents and staff across 16 long-term care homes (LTCHs) in Ontario, Canada.
Allison McGeer, a senior clinician scientist at Sinai Health’s Toronto-based Lunenfeld-Tanenbaum Research Institute will be the primary investigator of the phase 2 trial.
Allison McGeer said: “Given the severity of COVID-19 amongst the elderly, and the evidence of ongoing transmission with severe outcomes in LTCHs, it is critical to develop interventions that minimize the spread of disease in this setting. As vaccines and treatment for COVID-19 remain unavailable, we must explore all possible solutions.
“We look forward to working with Appili on this study, as the pandemic continues to present devastating consequences for LTCH residents and their families.”
Designed as a broad-spectrum antiviral, favipiravir is approved in Japan under the Avigan brand name. Japanese health authorities granted approval in 2014 for FUJIFILM Toyama Chemical to use Avigan as a treatment and stockpile countermeasure for outbreaks of pandemic influenza.
According to Appili Therapeutics, the primary goal of its phase 2 clinical trial is to assess the efficacy of favipiravir for 25 days compared with placebo as prophylaxis against Covid-19 outbreaks in LTCHs.
The mid-stage trial’s primary endpoint will be control of the outbreak which is defined as no new cases of Covid-19 in residents for 24 consecutive days up to Day 40 after the start of prophylaxis.
Among the secondary objectives are measures of safety, infection rates, disease progression, and also fatality rates.
Appili Therapeutics chief medical officer Yoav Golan said: “With the strikingly high fatality rate from COVID-19 in long-term care facilities, there is a particularly urgent need to protect our most vulnerable members of society.
“Preventing and controlling COVID-19 outbreaks in long-term care facilities is therefore of extreme importance.
“Industry and academia are coming together in unprecedented ways to mitigate this crisis, and Appili is proud to be part of this unique collaboration.”