Policy & Regulation
Health Canada Clears Appili Therapeutics' Phase 2 Clinical Trial Evaluating Favipiravir as a Prophylactic Agent Against COVID-19 Outbreaks
22 May 2020 - - Health Canada provided regulatory clearance for Canada-based biopharmaceutical company Appili Therapeutics Inc.'s (TSX Venture: APLI) Phase 2 study evaluating Fujifilm Toyama Chemical's favipiravir as a preventative measure against COVID-19 outbreaks, the company said.

Dr. Allison McGeer, senior clinician scientist at Sinai Health's Lunenfeld-Tanenbaum Research Institute in Toronto, Ontario is the study's primary investigator.

Appili expects trial recruitment to begin imminently. Researchers will enroll approximately 760 subjects, both residents and staff, at 16 long-term care homes (LTCHs) in Ontario. The National Institute on Ageing has estimated that as of May 6, 2020, 82 % of deaths related to COVID-19 in Canada were associated with long-term care facilities.i
The partially blinded, cluster randomized placebo-controlled trial (cluster-RCT) will recruit approximately 760 participants across 16 LTCHs in Ontario. Investigators from the University of Toronto, Sunnybrook Health Sciences Centre, and Unity Health Toronto are also participating in the study.

The primary objective of the Phase 2 trial is to evaluate the efficacy of favipiravir or 25 days compared with placebo as a prophylaxis to prevent COVID-19 outbreaks in LTCHs.

The primary endpoint will be outbreak control, defined as no new cases of COVID-19 in residents for 24 consecutive days up to Day 40 after the start of prophylaxis. Secondary objectives include measures of safety, rates of infection, disease progression, and fatality rates.

The company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time.

Favipiravir is a broad-spectrum antiviral approved in Japan under the brand name Avigan. Japanese health authorities provided approval to FFTC in 2014 to use Avigan as a treatment and stockpile countermeasure for pandemic influenza outbreak. Recent studies suggest favipiravir may have potential utility for the treatment of COVID-19.

Researchers in Wuhan, China, reported in early February that favipiravir demonstrated anti-viral activity in vitro against SARS-CoV-2.

Small-scale clinical trials conducted in China have also indicated that favipiravir may provide clinical benefit in patients with COVID-19.

Appili Therapeutics was founded to advance the global fight against infectious disease.
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