Mr. Yoav Golan reports
HEALTH CANADA CLEARS APPILI THERAPEUTICS' PHASE 2 CLINICAL TRIAL EVALUATING FAVIPIRAVIR AS A PROPHYLACTIC AGENT AGAINST COVID-19 OUTBREAKS
Health Canada has provided regulatory clearance for Appili Therapeutics Inc.'s phase 2 study evaluating FujiFilm Toyama Chemical's (FFTC) favipiravir as a preventative measure against COVID-19 outbreaks. Dr. Allison McGeer, senior clinician scientist at Sinai Health's Lunenfeld-Tanenbaum Research Institute in Toronto, Ont., 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 per cent of deaths related to COVID-19 in Canada were associated with long-term care facilities (i).
"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," said Dr. McGeer. "We look forward to working with Appili on this study, as the pandemic continues to present devastating consequences for LTCH residents and their families."
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 end point 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.
"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," said Yoav Golan, MD, chief medical officer at Appili Therapeutics. "Industry and academia are coming together in unprecedented ways to mitigate this crisis, and Appili is proud to be part of this unique collaboration. Dr. McGeer and her team at Mount Sinai, along with our other medical partners from some of the premier institutions in Toronto, have extensive experience in working to mitigate respiratory infections in long-term care settings. Together with the support from FFTC, we are in a unique position to evaluate the utility of favipiravir as a COVID-19 prophylaxis to control further outbreaks in these facilities, which could be a significant advance for Canadian patients, with implications for global application in similar high-risk outbreak settings."
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 (ii) (iii). 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.
About Appili Therapeutics Inc.
Appili Therapeutics was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors and society face in this critical disease space.
(i) Tonda MacCharles. 82% of Canada's COVID-19 deaths have been in long-term care, new data reveals. The Star accessed on-line May 7, 2020.
(ii) Cai et al. (2020) Experimental Treatment with Favipiravir for COVID-19: An Open-Label Control Study. Engineering.
(iii) Chen et al. (2020) Favipiravir versus arbidol for COVID-19: A Randomized Clinical Trial. medRxiv preprint doi.
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