11 September 2020 - - Canadian biopharmaceutical company Appili Therapeutics Inc. (TSX Venture: APLI) (OTCQX: APLIF) has submitted a new protocol to its open investigational new drug application with the US Food and Drug Administration to conduct a Phase 3 clinical study evaluating favipiravir in the early treatment outpatient setting for adult COVID-19 infections, the company said.

Favipiravir is a broad-spectrum antiviral administered in oral tablet form. Investigators will seek to determine if favipiravir is a safe and effective treatment for mild-to-moderate COVID-19 infections and, if administered early, may shorten the time to clinical recovery and keep the infection from progressing into the severe or life-threatening form of the illness.

Appili's study is designed to be a randomised, double-blind placebo-controlled, multi-center Phase 3 trial investigating the safety and efficacy of favipiravir in the early treatment outpatient setting for adult COVID-19 infections with mild to moderate symptoms.

Appili plans to recruit 826 eligible participants, who are recently diagnosed as COVID-19 positive with mild to moderate symptoms, across multiple clinical trial sites in the US Participants are expected to be outpatients who do not require hospitalization and who have had a positive COVID-19 test.

Participants will self-administer the drug regimen in their homes, with clinical investigators monitoring them remotely. Appili expects to initiate trial recruitment in the Fall of 2020.

In a sub study, researchers intend to further examine 136 trial participants to evaluate favipiravir's effect on viral shedding. This occurs when the virus is contagious, replicating inside the body, and is released into the environment.

In this portion of the study, investigators are seeking to determine if treatment with favipiravir can shorten the period of viral shedding, thus diminishing the period of infectivity and decreasing the spread of the virus.

Favipiravir is a broad-spectrum antiviral in oral tablet form originally developed by FUJIFILM Toyama Chemical Inc. and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza under the name AVIGAN.

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

Clinicians are conducting additional trials evaluating favipiravir as a treatment for COVID-19 in countries including Japan, China, and the United Kingdom.

Appili Therapeutics Inc. was founded to advance the global fight against infectious disease by matching clearly defined patient needs with drug development programs that provide solutions to existing challenges patients, doctors, and society face in this critical disease space.

Appili has built a pipeline of assets designed to address a range of significant unmet medical needs in the infectious disease landscape.

This diverse pipeline aims to address some of the most urgent threats in global public health, including ATI-2307, a novel, broad spectrum, clinical-stage antifungal candidate in development for severe and difficult-to-treat invasive fungal infections; ATI-1701, a vaccine candidate for tularemia, a very serious biological weapons threat; ATI-1503, a drug discovery program aimed at generating a novel class of antibiotics with broad-spectrum activity against Gram-negative superbugs; and ATI-1501, which employs Appili's proprietary, taste-masked, oral-suspension technology with metronidazole for the growing number of patients with difficulty swallowing.

In addition, the company is also testing Fujifilm Toyama Chemical Inc.'s drug favipiravir for the prevention of COVID-19 as a potential prophylaxis treatment.

Headquartered in Halifax, Nova Scotia, with offices in Toronto, Ontario, Appili is pursuing worldwide opportunities in collaboration with scientific and industry commercial partners, governments and government agencies.