17 June 2021 - - Canada-based biopharmaceutical company Appili Therapeutics Inc. (TSX: APLI) (OTCQX: APLIF) has added several clinical research sites in Mexico and Brazil to its Phase 3 clinical trial evaluating Avigan/Reeqonus (favipiravir) as a potential oral therapy for patients with mild-to-moderate COVID-19, the company said.

The expansion into Mexico and Brazil will ensure a timely completion of this pivotal trial and reaffirm favipiravir as one of the most advanced oral COVID-19 antiviral candidates in development with top-line data expected in 3Q21.

Appili's PRESECO (PREventing SEvere COVID-19) study is evaluating the safety and efficacy of Avigan/Reeqonus, an oral antiviral that selectively inhibits viral RNA-dependent RNA polymerase, as a potential home-based treatment for patients with mild-to-moderate COVID-19.

The primary goal of the study is to demonstrate a significant shortening of the time to sustained recovery for study patients receiving the experimental medicine compared to a placebo.

There are more than 730 US patients currently enrolled in the PRESECO study.

Site activation is underway in Mexico and the first sites are active and enrolling patients. Site activation in Brazil is expected to start in the coming weeks.

With the addition of the new sites, Appili expects to complete enrollment and report top-line results by the end of September.

Recently, an independent Data and Safety Monitoring Board recommended continuation of PRESECO without modification.

This expansion is a key component of continuing the trial completion.

As part of the expansion and prioritization of the PRESECO treatment study, Appili has ended its CONTROL trial.

CONTROL was a Phase 2 trial designed to determine whether Avigan/Reeqonus could prevent an outbreak of COVID-19 in long-term care settings and originally developed in collaboration with researchers at Sinai Health as part of the early response to the COVID-19 pandemic.

Appili has also planned a Phase 3 study PEPCO (Post Exposure Prophylaxis for COVID-19), designed to evaluate Avigan/Reeqonus for the prevention of COVID-19 when given to asymptomatic individuals who have had direct exposure (within 72 hours) to an infected person.

Appili expects to initiate enrollment in the second half of 2021 following successful completion of the PRESECO study.

The Phase 3 PRESECO (Preventing Severe COVID-19 Disease) study is a double-blind, placebo-controlled, randomized, multi-center superiority trial investigating the safety and efficacy of Avigan/Reeqonus in the early treatment outpatient setting for adults infected with COVID-19 and showing mild-to-moderate symptoms. Investigators are enrolling participants at multiple clinical trial sites in the United States.

Participants are expected to be outpatients who do not require hospitalization and who have had a recent positive COVID-19 test (within 72 hours of enrollment). Participants self-administer the drug regimen in their homes, with clinical investigators monitoring them remotely.

Avigan/Reeqonus is a broad-spectrum antiviral in oral tablet form.

It is a selective inhibitor of viral RNA-dependent RNA polymerase with potent antiviral activity against single-stranded RNA viruses, including coronaviruses.

Developed by Fujifilm Toyama Chemical Co., Ltd. and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza.

Unlike most other interventions that researchers are evaluating in COVID-19, Avigan/Reeqonus 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/Reeqonus' 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.

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

This consortium is designed to ensure that Avigan/Reeqonus is thoroughly evaluated in rigorous clinical studies and, if it receives the proper regulatory approvals, has the infrastructure in place to support worldwide manufacturing and distribution.

Appili Therapeutics is an infectious disease biopharmaceutical company that is purposefully built, portfolio-driven, and people-focused to fulfill 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/Reeqonus for the worldwide treatment and prevention of COVID-19.

The company is also 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. Led by a proven management team, Appili is at the epicenter of the global fight against infection.