Appili Therapeutics submits clinical trial application with Health Canada

11th May 2020 (Last Updated May 11th, 2020 16:33)

Anti-infective drug development-focused biopharmaceutical firm Appili Therapeutics has filed a clinical trial application (CTA) with Health Canada to sponsor the first clinical trial evaluating antiviral drug favipiravir for the prevention of coronavirus (Covid-19).

Appili Therapeutics submits clinical trial application with Health Canada
The trial will assess the drug in Covid-19 patients with mild to moderate infection. Credit: Gerd Altmann from Pixabay.

Anti-infective drug development-focused biopharmaceutical firm Appili Therapeutics has filed a clinical trial application (CTA) with Health Canada to sponsor the first clinical trial evaluating antiviral drug favipiravir for the prevention of coronavirus (Covid-19).

Covid-19 is a respiratory infection caused by the novel SARS-CoV-2 coronavirus.

Favipiravir is a generic version of Fujifilm Toyama Chemical’s influenza drug Avigan, which holds approval in Japan for the treatment of influenza virus infections.

With Fujifilm providing support through donated drug product, the Phase II study will be conducted at long-term care facilities in Ontario, Canada. The trial is a cluster randomised placebo-controlled trial (cluster-RCT).

Last month, Fujifilm initiated a Phase II study of Avigan (favipiravir) to treat Covid-19 patients in the US. The trial will evaluate the drug’s safety and efficacy as a potential Covid-19 therapy.

The company also commenced a Phase III trial of Avigan for the treatment of Covid-19 patients in Japan.

Appili Therapeutics CEO Armand Balboni said: “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 programme and significant contribution to the global dataset that is needed to help address this crisis.

“Appili was built to tackle the most urgent needs in infectious diseases in innovative ways that no other organisation could or would be willing to take on.

“This programme illustrates our commitment to leverage our relationships and expertise to do the right thing for patients and public health.”

According to Appili, the primary endpoint will be to assess the safety and efficacy of the drug in the prevention of further outbreak of Covid-19 in long-term care facilities, while secondary endpoints will assess favipiravir’s ability to restrain disease progression in this patient population.

Last month, Glenmark Pharmaceuticals received approval from the Drug Controller General of India (DCGI) to evaluate favipiravir in clinical trials to treat patients with Covid-19.