Appili Therapeutics has completed subject enrolment in the viral shedding sub-study portion of its Phase III PRESECO clinical trial assessing Avigan/Reeqonus (favipiravir) as a potential therapy for Covid-19 in the US.
The sub-study concluded enrolment by recruiting more than 550 subjects while the complete enrolment for the Phase III PRESECO trial is underway.
Developed by Fujifilm Toyama Chemical, Avigan/Reeqonus is a broad-spectrum oral antiviral drug.
It specifically hinders viral RNA-dependent ribonucleic acid (RNA) polymerase (RdRP) with potent antiviral activity against single-stranded RNA viruses such as coronaviruses.
The double-blind, placebo-controlled, randomised, multicentre superiority Phase III trial is evaluating the safety and efficacy of Avigan/Reeqonus as early therapy for adult Covid-19 patients with mild-to-moderate symptoms.
The trial is currently recruiting Covid-19 patients with mild-to-moderate symptoms at several study centres in the US, Brazil and Mexico in the outpatient setting.
Subjects in the trial will administer the drug themselves in the at-home setting while the trial investigators will monitor them remotely.
The viral shedding sub-study is intended to detect SARS-CoV-2 variants in subjects and analyse the direct antiviral effect of Avigan/Reeqonus against the virus, including the latest and emerging variants.
Antiviral efficacy goals in subjects with detectable virus levels in saliva will be investigated from study day three onward and comprise time to negative conversion to day ten.
The results from the viral shedding sub-study and top-line data from the PRESECO trial are anticipated to be reported simultaneously, Appili noted.
Appili Therapeutics chief medical officer Yoav Golan said: “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.
“This sub-study, which includes patients recently enrolled from regions with high Covid-19 variant caseloads, will provide critical data to assess Avigan/Reeqonus’ antiviral efficacy against today’s most relevant variants.”
The company noted that the enrolment targets for the PRESECO and sub-study were raised lately to expand the number of cases included in the analysis.
This will also aid in guaranteeing a sufficient representation of variants such as Delta, which is currently dominant worldwide.
In June 2021, Appili expanded the Phase III trial of Avigan/Reeqonus with the addition of multiple clinical research centres in Mexico and Brazil to treat mild to moderate Covid-19.