Benzinga | Nov 24, 2020 07:18AM EST

Health Canada Clears Appili Therapeutics For New Phase 3 Clinical Trial To Evaluate Avigan Tablets In Prevention Of COVID-19 In Exposed Individuals In The Community

Company signs agreement with CRO and files Phase 3 clinical trial protocol with U.S. FDA in advance of anticipated study initiation in the U.S.

Double-blind, randomized, placebo-controlled study will include approximately 1,156 participants in the U.S. and Canada; Appili expects enrollment to begin early 2021

The ability to prevent outbreaks in the community setting with an antiviral oral tablet would provide substantial benefits over other approaches currently under study

Appili Therapeutics Inc. (TSX:APLI, OTCQX:APLIF) (the "Company" or "Appili"), a biopharmaceutical company focused on anti-infective drug development, today announced initiation of its Phase 3 Post Exposure Prophylaxis for COVID-19 (PEPCO) study to evaluate Avigan(r) tablets (favipiravir) in the prevention of COVID-19. Health Canada has provided a 'No Objection Letter (NOL)' for Appili's proposed study; the U.S. FDA accepted a submission of a protocol amendment to conduct the trial in the United States.

"Addressing infections and spread early in the community setting remains a particular unmet need for COVID-19, and that is the cornerstone of our clinical strategy," said Dr. Armand Balboni, Chief Executive Officer, Appili Therapeutics. "Since Avigan comes in a pill form, it allows for easier administration than other approaches, which usually require injections or intravenous administration, and also enables patients to receive it early after exposure."

The primary objective of the PEPCO study is to determine if the use of Avigan is safe and effective in preventing COVID 19 among vulnerable individuals who have had recent direct exposure to a confirmed COVID-19-infected person. Appili has contracted with CATO Research LLC, a third-party clinical research organization, to administer the trial in Canada and the United States. Appili expects to initiate enrollment and dosing before the end of 2020.

This is the second Phase 3 study Appili has announced to evaluate the utility of Avigan tablets against COVID-19 in the community setting. The other study, also known as the PRESECO study, is evaluating Avigan for the treatment of adults with mild-to-moderate symptoms of COVID-19. PRESECO's objective is to determine if Avigan is safe and effective in shortening the time to clinical recovery, preventing progression to severe disease, and diminishing the period of infectiousness. In addition to the PEPCO and PRESECO studies, Appili is sponsoring a Phase 2 CONTROL study evaluating the use of Avigan to control outbreaks of COVID-19 in Canadian long-term care facilities, where the burden of severe disease and death is unusually high.

"Our clinical strategy focuses on determining when, and who, may benefit most from using Avigan to treat and prevent outbreaks of COVID-19. The PEPCO study aims at providing early intervention to those most vulnerable to severe infections, with the aim of controlling outbreaks in homes and outpatient facilities," said Dr. Yoav Golan, Chief Medical Officer, Appili Therapeutics. "We look forward to continuing to work with our partners to advance this important study."

About the PEPCO Study