Appili Therapeutics Announces Completion of Patient Enrollment for Avigan/Reeqonus Viral Shedding Sub- Study for Mild-to-Moderate COVID-19 Patients
Appili Therapeutics Inc. (TSX: APLI; OTCQX: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases, today announced it has completed patient enrollment in the viral shedding sub-study portion of its Phase 3 PRESECO (PREventing SEvere COVID-19) trial evaluating Avigan/Reeqonus (favipiravir) as a potential oral antiviral COVID-19 treatment in the United States.
The viral shedding sub-study is designed to identify COVID-19 variants in study patients and evaluate the direct antiviral effect of favipiravir against the SARS-CoV-2 virus, including recent and emerging variants. Saliva samples are being collected daily from sub-study participants for viral load assessments and whole genome sequencing. Antiviral efficacy endpoints in study participants with detectable SARS-CoV-2 virus in saliva (defined as >100 RNA copies, using an RT-PCR assay) will be assessed from study day 3 onward and include time (number of days) to negative conversion (defined as <100 RNA copies) to study day 10.
PRESECO and sub-study enrollment targets were recently increased to maximize the number of cases included in the analysis and to ensure that there is an adequate representation of variants, including Delta, which is now dominant worldwide. The sub-study is now fully enrolled with over 550 patients and full enrollment for the overall study is imminent.
“The need for an oral, safe and effective antiviral that can be taken at home early in the course of COVID-19, such as Avigan/Reeqonus, has never been greater and will continue to grow as this virus evolves and mutates in response to a changing environment,” said Yoav Golan, M.D., Chief Medical Officer, Appili Therapeutics. “This sub-study, which includes patients recently enrolled from regions with high COVID-19 variant case loads, will provide critical data to assess Avigan/Reeqonus’ antiviral efficacy against today’s most relevant variants.”
Viral shedding sub-study results are expected concurrently with PRESECO top-line results.
About the PRESECO Clinical Trial
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 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, Brazil and Mexico. Participants are outpatients with mild-to-moderate symptoms 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 patients remotely.