Publicly traded Appili Therapeutics out of Canada, a biotech venture attempting to commercialize Avigan® tablets (favipiravir), the antiviral drug originating from Japan that has been approved in Russia, Eastern Europe and on an emergency basis in India and China for mild-to-moderate COVID-19 cases, now initiates a Phase 3 clinical trial investigating use of the treatment for Post Exposure Prophylaxis called PEPCO. The Canadian sponsor seeks to determine if favipiravir can actually prevent COVID-19 in individuals who have had a household contact, for example. After reviewing the company’s submission, Health Canada provided a ‘No Objection Letter’ (NOL) while the United States Food and Drug administration (FDA) accepted a submission of a protocol amendment to greenlight the same study in America. Although promising vaccines may receive emergency use authorization soon, a holistic and ultimately comprehensive global response to COVID-19 will include a combination of vaccine, therapeutic treatments, and diagnostics.
The Unmet Need
Although the billions spent thus far by the U.S. government and the biopharmaceutical industry points to highly promising vaccine candidates and some powerful potential monoclonal antibody therapies, little progress has been made to either treat early onset, mild-to-moderate COVID-19 nor introduce Post Exposure Prophylaxis.
As the biotech firm’s CEO Dr. Armand Balboni declared in their latest press release, “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.” Formerly with the U.S. Army, Dr. Balboni continued, “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 Goal of the Study
Appili Therapeutics seeks 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.
Contract Research Organization (CRO) Partner
The Canadian firm has contracted with a contract research organization (CRO) to manage the PEPCO study. CATO Research LLC was selected and the partners plan on commencing patient enrollment and dosing prior to the end of 2021.
Appili is running an ongoing clinical trial called the PRESECO study in an effort investigating the safety and efficacy of Avigan in shortening the time to clinical recovery, preventing progression to severe COVID-19 and diminishing the period of infectiousness.
They are also sponsoring a Phase 2 CONTROL study evaluating the use of Avigan to control outbreaks of COVID-19 in Canadian long-term care facilities. Nursing homes and other long-term care centers in Canada and the United States have experienced particularly horrific conditions. For example in the United States about 40% of all COVID-19 fatalities were associated with residents in these facilities.
About the PEPCO Study
PEPCO is a double-blinded, placebo-controlled, randomized, multinational, Phase 3 clinical trial that will enroll approximately 1,156 participants through 47 medical centers (“sites”). 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.
About Avigan (Favipiravir)
Avigan® is a broad-spectrum antiviral in oral tablet form developed by FUJIFILM Toyama Chemical Co., Ltd. (FFTC) 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.
About Appili Therapeutics
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. Led by a proven management team, Appili positions itself as at the epicenter of fighting the COVID-19 pandemic. With a number of forward looking statements Appili represents a microcap stock, hence with less capital than larger firms representing more risk.