First Patient Dosed in Appili Therapeutics’ Phase 3 Clinical Trial of Avigan® Tablets (Favipiravir) for the Treatment of COVID-19 in the United States


HALIFAX, Nova Scotia– Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on anti-infective drug development, announced today that 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. Appili has engaged PRA Health Sciences as a clinical research organization (CRO) 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.

“Dosing the first participants in our first Phase 3 trial is a significant milestone as we work to stem the tide of this coronavirus,” said Dr. Yoav Golan, Chief Medical Officer, Appili Therapeutics. “Early intervention with patients before they develop severe COVID-19 and require hospitalization remains a significant unmet need in the COVID-19 treatment landscape. As is the case with influenza, we believe that even with effective vaccines, oral antivirals will play a critical role in treating COVID-19 and preventing its progression. Avigan’s pill format and shelf-life stability make it particularly well-suited for this endeavor and we look forward to gathering the necessary data to determine Avigan’s utility for these patients.”