24 November 2020 - - Canada-based biopharmaceutical company Appili Therapeutics Inc. (TSX: APLI) (OTCQX: APLIF) has initiated its Phase 3 Post Exposure Prophylaxis for COVID-19 (PEPCO) study to evaluate Avigan tablets (favipiravir) in the prevention of COVID-19, the company said.

Health Canada has provided a 'No Objection Letter ' for Appili's proposed study; the US FDA accepted a submission of a protocol amendment to conduct the trial in the United States.

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.

PEPCO is a double-blinded, placebo-controlled, randomized, multinational, Phase 3 clinical trial that will enroll approximately 1,156 participants through 47 medical centers.

Site investigators will oversee participant enrollment, intervention, and follow-up during the course of the study. Participants will be outpatients residing in assisted living facilities or their own private residences.

Researchers will be evaluating the safety and efficacy of Avigan in preventing the development of COVID-19 when given to asymptomatic individuals who had direct exposure (within 72 hours) to an infected person.

Inclusion criteria focuses on vulnerable individuals who are at high risk of developing severe complications of COVID-19, including individuals 60 years of age or older regardless of having underlying comorbidities, or individuals who are 18 years of age or older who have at least one significant underlying condition.

The PEPCO (preventative) and PRESECO (treatment) trials are designed to give researchers the option to accelerate enrollment by coordinating with infected individuals and those they may have exposed, wherein those who test positive for COVID-19 are enrolled into the PRESECO trial, and consenting associates with whom they've been in contact may be enrolled in the PEPCO study.

The PEPCO and PRESECO studies will be part of the dataset for the recently announced consortium to develop and distribute Avigan tablets globally in COVID-19 indications.

As part of that agreement, Appili is focused initially on clinical development in the United States and Canada.

Appili may expand these trials into other countries severely affected by COVID, including those in Central and South America and the European Union.

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 known safety profile, with over 3,000 subjects receiving at least one dose of the drug.

There is also an established manufacturing process in place that can be used to ramp up supply, should the drug receive regulatory approvals in additional indications.

Avigan's oral tablet form is shelf-stable and may provide advantages in the community setting over other COVID-19 interventions, which often require temperature-controlled storage and/or injection or intravenous administration.

Appili has joined a consortium of companies, including Dr. Reddy's Labs, Global Response Aid, and FFTC, for the worldwide development and distribution of Avigan tablets for the potential treatment and prevention of COVID-19 (excluding Japan, China, and Russia.)

The purpose of this consortium is to ensure that Avigan is thoroughly evaluated in rigorous clinical studies and, if it receives the proper regulatory approvals, has the infrastructure in place to support worldwide distribution.

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused in fulfilling its mission of solving life-threatening infections.

By systematically identifying urgent infections with unmet needs, Appili's goal is to strategically develop a pipeline of novel therapies to prevent deaths and improve lives.

As part of a global consortium, Appili is sponsoring late-stage clinical trials evaluating the antiviral Avigan (favipiravir) for the worldwide treatment and prevention of COVID-19.

In addition, Appili is advancing a diverse range of anti-infectives, including a broad-spectrum antifungal, a vaccine candidate to eliminate a serious biological weapon threat, and two novel antibiotic programs.