Policy & Regulation
First Patient Dosed in Appili Therapeutics' Phase 3 Clinical Trial of Avigan Tablets for the Treatment of COVID-19 in the United States
3 December 2020 - - Investigators have dosed the first participant in its Phase 3 trial (referred to as the "PRESECO" clinical trial) evaluating oral Avigan tablets (favipiravir) for the treatment of COVID-19, Canada-based biopharmaceutical company Appili Therapeutics Inc. (TSX: APLI) (OTCQX: APLIF) said.

Appili has engaged PRA Health Sciences as a clinical research organization to administer the trial at 47 outpatient sites.

The randomized, double-blind, placebo-controlled study will enroll approximately 826 participants.

This study is the second Appili-sponsored COVID-19 clinical trial that has initiated dosing this quarter.
Appili expects to report early data from the PRESECO study in the first half of 2021. Appili is initially focusing the trial in the United States but may expand the program to other areas of the world affected by COVID-19.

Avigan is a broad-spectrum antiviral in oral tablet form developed by Fujifilm Toyama Chemical Co., Ltd. and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza.

Following promising clinical studies, Russia and India recently approved favipiravir-based antiviral medications for the emergency treatment of COVID-19.

FFTC recently announced positive Phase 3 data in the use of Avigan in hospitalized COVID-19 patients.

Unlike most other interventions that researchers are evaluating in COVID-19, Avigan has already been thoroughly studied in human trials and has a well-known safety profile, with over 3,000 subjects receiving at least one dose of the drug.

Avigan's oral tablet form is shelf-stable and has an established commercial manufacturing process, which may provide advantages over other COVID-19 interventions, which often require temperature-controlled storage and/or injection or intravenous administration.