Appili Therapeutics submits CTA with Health Canada to sponsor trial of favipiravir as preventative m

Appili Therapeutics said that it will sponsor the first clinical trial evaluating FUJIFILM Toyama Chemical’s (FFTC) drug favipiravir for the prevention of COVID-19, a respiratory infection caused by the novel SARS-CoV-2 coronavirus.

Favipiravir is approved in Japan as the anti-influenza drug Avigan. With FFTC providing support through donated drug product, the phase 2 study will be conducted at long-term care facilities in Ontario. Appili has filed the clinical trial application (CTA) with Health Canada and expects to initiate the trial as soon as possible following receipt of regulatory clearance.

“As the world races to address the COVID-19 pandemic, Appili is proud to support this endeavour that is looking at this problem specifically in Canada’s most vulnerable patients, establishing a world-class clinical program and significant contribution to the global dataset that is needed to help address this crisis,” said Armand Balboni, MD, PhD, Chief Executive Officer, Appili Therapeutics. “Appili was built to tackle the most urgent needs in infectious diseases in innovative ways that no other organization could or would be willing to take on. This program illustrates our commitment to leverage our relationships and expertise to do the right thing for patients and public health.”

Favipiravir is a broad-spectrum antiviral developed by FFTC and approved in Japan under the brand name Avigan. Japanese health authorities provided approval to FFTC in 2014 to use Avigan as a treatment in a pandemic influenza outbreak. Favipiravir was also used in a clinical trial to address the Ebola outbreak in Guinea. FFTC is actively supporting several controlled clinical trials for favipiravir to investigate its use against COVID-19. Recent studies suggest favipiravir may have potential utility for the treatment of COVID-19.i ii Researchers in Wuhan, China, reported in early February that favipiravir demonstrated anti-viral activity in vitro against SARS-CoV-2. Small-scale trials conducted in China have also indicated that favipiravir may provide clinical benefit in patients with COVID-19.

“We have an ongoing relationship with Appili and are pleased to support the company in its efforts to assess favipiravir for the potential benefit of Canadian patients,” said Junji Okada, President of FFTC. “We are well-aligned with Appili in our commitment to innovative R&D work that may address public health crises by mitigating the threat of deadly infections.”

The cluster randomized placebo-controlled trial (cluster-RCT) will recruit patients at multiple long-term care facilities throughout Ontario. The primary endpoint will be the safety and efficacy of favipiravir in the prevention of further outbreak in long-term care facilities. Secondary endpoints will assess favipiravir’s potential to inhibit disease progression in this subject population. As of May 2020, the majority of deaths in Canada resulting from COVID-19 have occurred in long-term care facilities, making this population especially vulnerable to the pandemic.