Appili Submits Protocol to FDA for Phase 3 Study for COVID Treatment

Appili Therapeutics Inc., a biopharmaceutical company focused on anti-infective drug development, recently announced it has submitted a new protocol to its open investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) to conduct a Phase 3 clinical study evaluating favipiravir in the early treatment outpatient setting for adult COVID-19 infections, according to a news release.

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.

“As the global incidence of COVID-19 cases continues to rise at alarming rates, and we learn more about the virus and patient demographics, it is clear that we will need multiple approaches to effectively quell this pandemic,” says Dr. Armand Balboni, chief executive officer at Appili Therapeutics. “As part of this global effort, Appili has focused on the outpatient setting with the first orally available antiviral for the potential treatment of COVID-19 in adults with mild to moderate disease. We look forward to working with clinical teams to rigorously study the utility of favipiravir, helping to determine if it can help reduce the spread and inhibit COVID-19 disease progression.”

Appili’s study is designed to be a randomized, 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, the release says.

The company 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 U.S. 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.

“Helping to reduce the time to clinical recovery and infection severity could reduce the need for invasive and costly measures such as hospitalizations,” says Yoav Golan, MD, chief medical officer, Appili Therapeutics. “Reducing the duration in which a patient is contagious could help reduce secondary cases and infection spread. Our goal is to generate robust clinical data that can help determine if favipiravir can safely and effectively support these outcomes. Favipiravir’s preliminary clinical data, broad spectrum antiviral activity, and oral formulation make this an exciting candidate for early intervention and treatment against COVID-19.”

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, the release says.