Appili Therapeutics has concluded subject enrolment in its international Phase III PRESECO clinical trial of oral Avigan/Reeqonus (favipiravir) as a potential drug for Covid-19.
The trial enrolled 1,231 subjects from 38 trial centres across the US, Mexico, and Brazil.
Developed by Fujifilm Toyama Chemical, Avigan/Reeqonus is a broad-spectrum oral antiviral drug.
It specifically hinders viral RNA-dependent ribonucleic acid (RNA) polymerase (sRdRP) with potent antiviral activity against single-stranded RNA viruses such as coronaviruses.
The company raised the enrolment targets to increase the number of patients and SARS-CoV-2 variant cases, including Delta variant, in the trial.
Appili commenced the trial in November 2020 to assess oral Avigan/Reeqonus as a potential at-home treatment for Covid-19.
The double-blind, placebo-controlled, randomised, multicentre Phase III superiority trial is assessing the safety and efficacy of oral Avigan/Reeqonus as the early therapy for adult Covid-19 patients with mild-to-moderate symptoms.
Participants will comprise outpatients who were tested positive for Covid-19 within 72 hours of recruitment.
Subjects in the trial will administer the drug themselves in the at-home setting and the trial investigators will monitor them remotely.
The impact of oral antiviral on time to Covid-19 symptom resolution will be the primary goal of the trial.
Furthermore, the trial will assess the impact of the drug on disease progression to severe Covid-19.
It also comprises a viral shedding sub-study, which is analysing the impact of Avigan/Reeqonus on time to viral clearance.
Last week, Appili completed subject enrolment in the viral shedding sub-study portion of Avigan/Reeqonus in the US.
In addition, viral isolates will be sequenced for detecting SARS-CoV-2 variants in the PRESECO trial.
Appili Therapeutics CEO Armand Balboni said: “Completing enrolment in this large Phase III 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.”
Top-line results from the trial are expected in nearly 60 days.