Oral Antiviral Flounders Against COVID-19

Canada-based Appili Therapeutics Inc. today announced that the Phase 3 clinical trial evaluating oral antiviral Avigan® / Reeqonus™(favipiravir) for treating mild-to-moderate COVID-19 did not achieve statistical significance on the primary endpoint of time to sustained clinical recovery.

The clinical trial enrolled 1,231 patients with mild-to-moderate COVID-19 from 38 study sites across the United States, Mexico, and Brazil.

Additional analyses of the trial data are ongoing.

Avigan/Reeqonus is a broad-spectrum oral antiviral and is a selective inhibitor of viral RNA-dependent RNA polymerase with potent antiviral activity against single-stranded RNA viruses, including coronaviruses.

"While we are disappointed by the topline results of the PRESECO trial, we remain steadfast in our belief that safe and effective oral antivirals are urgently needed for patients who are still struggling to overcome COVID-19," commented Dr. Armand Balboni, CEO, Appili Therapeutics, in a press release.

The PREventing SEvere COVID-19 Disease study is a double-blind, placebo-controlled, randomized, multi-center, global superiority trial investigating the safety and efficacy of oral Avigan/Reeqonus in the early treatment for adults infected with COVID-19 and showing mild-to-moderate symptoms.

Participants were outpatients with mild-to-moderate symptoms who have had a recent positive COVID-19 test (within 72 hours of enrollment).

And the participants self-administered the drug regimen in their homes, with clinical investigators monitoring patients remotely.

Developed by FUJIFILM Toyama Chemical Co., Ltd. and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza, Avigan has been 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 oral tablet form is shelf-stable. In addition, it 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 Therapeutics is an infectious disease biopharmaceutical company located in Nova Scotia, Canada, purposefully built, portfolio-driven, and people-focused to fulfill its mission of solving life-threatening infections.