Study expected to include patients with top priority COVID-19 variants, including Delta
Infectious disease company, Appili Therapeutics (TSX: APLI; OTCQX: APLIF), has completed enrollment in its global Phase 3 PRESECO (PREventing SEvere COVID-19) trial evaluating Avigan®/Reeqonus™(favipiravir) as an oral treatment for COVID-19. Appili expects to report top-line data from this trial in approximately 60 days.
With today’s announcement, the double-blind, placebo-controlled, randomized, global, multi-center trial has enrolled 1,231 patients from 38 study sites across the United States, Mexico, and Brazil.
“Completing enrollment in this large Phase 3 pivotal trial in just ten months is a tremendous accomplishment for Appili. With this major milestone now achieved, we have a clear path to completing the PRESECO data analysis in the coming weeks and determining if Avigan/Reeqonus has the potential to meet the urgent global clinical need for a safe and effective oral treatment for this deadly disease,” said Armand Balboni, M.D., Ph.D., Chief Executive Officer, Appili Therapeutics.
The primary goal of PRESECO is to evaluate the impact of oral Avigan/Reeqonus on time to COVID-19 symptom resolution. The study also aims to evaluate the effect of oral treatment on progression to more severe COVID-19 disease. Finally, this Phase 3 clinical trial includes a viral shedding sub-study, which is evaluating impact of the treatment on time to viral clearance. Viral isolates will also be sequenced for identification of COVID-19 variants.
“As we have seen over the past 18 months, this virus continues to mutate, enhancing its ability to infect and cause significant symptoms, especially in those who have not been vaccinated. My hope is that Avigan/Reeqonus will emerge as a standard of care treatment for mild to moderate COVID-19 patients, resolve patient’s symptoms more rapidly, and limit progression to more severe disease” said Yoav Golan, M.D., Chief Medical Officer, Appili Therapeutics.
About the PRESECO Clinical Trial
The Phase 3 PRESECO (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 enrolled 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.
Avigan/Reeqonus is a broad-spectrum antiviral in oral tablet form. It is a selective inhibitor of viral RNA-dependent RNA polymerase (RdRP) with potent antiviral activity against single-stranded RNA viruses, including coronaviruses. Developed by FUJIFILM Toyama Chemical Co., Ltd. (FFTC) and approved in Japan as a treatment and stockpile countermeasure for pandemic influenza. Unlike most other interventions that researchers are evaluating in COVID-19, Avigan/Reeqonus has already been thoroughly 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/Reeqonus’ oral tablet form is shelf-stable and 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 has joined a consortium of companies, including Dr. Reddy’s Laboratories, Global Response Aid, and FFTC, for the worldwide development and distribution of Avigan/Reeqonus tablets for the potential treatment and prevention of COVID-19 (excluding Japan, China, and Russia). This consortium is designed to ensure that Avigan/Reeqonus is thoroughly evaluated in rigorous clinical studies and, if it receives the proper regulatory approvals, has the infrastructure in place to support worldwide manufacturing and distribution.
Source: Appili Therapeutics Inc.