Appili Therapeutics is set to continue its ongoing Phase III PRESECO trial of oral therapy, Avigan/Reeqonus (favipiravir), without modification to treat mild-to-moderate Covid-19.
The move is in line with the recommendation by an independent Data and Safety Monitoring Board (DSMB), which found no safety concerns that need trial termination.
Furthermore, the DSMB did not suggest discontinuing the trial for futility.
Developed by Fujifilm Toyama Chemical, Avigan/Reeqonus is a broad-spectrum antiviral tablet currently approved for influenza treatment in Japan.
The double-blind, placebo-controlled, randomised, multi-centre superiority PRESECO trial is assessing the safety and efficacy of the Avigan/Reeqonus as early therapy for treating mild-to-moderate Covid-19 in adults in the outpatient setting.
As the primary objective, the trial intends to show a substantial reduction in time to sustained recovery of participants who are given the oral antiviral versus placebo.
Appili Therapeutics is enrolling patients at 27 sites in the US and anticipates reporting top-line data in the third quarter of this year.
The company intends to use this data to hold discussions with regulators and seek an emergency use authorization from the US Food and Drug Administration (FDA).
Appili Therapeutics CEO Dr Armand Balboni said: “A safe and effective oral anti-viral medicine is what government leaders and physicians around the world have been asking for since the start of the pandemic.
“We remain hopeful that once PRESECO is completed, Avigan/Reeqonus will emerge as the first prescription oral medicine for newly diagnosed patients with Covid-19.”
In a separate development, Regeneron Pharmaceuticals has presented results from the Phase III trial that showed its antibody cocktail, REGEN–COV, lowered the risk of hospitalisation or death, reduced symptom duration and lowered viral load in covid-19 patients in the outpatient setting.
A combination of two monoclonal antibodies, casirivimab and imdevimab, REGEN–COV can potentially hinder SARS-CoV-2 infectivity using the company’s VelocImmune and VelociSuite technologies.
In March, Roche reported that the Phase III REGN-COV 2067 trial of the antibody cocktail met its primary endpoint of reducing the risk of hospitalisation or death in treating high-risk, non-hospitalised Covid-19 patients by 70%.
Separately, a team of scientists from Menzies Health Institute Queensland (MHIQ) at Griffith University, Australia, and from the City of Hope in the US, has created an investigational direct-acting antiviral treatment for Covid-19.
Utilising gene-silencing RNA (ribonucleic acid) technology called small-interfering RNA (siRNA), this antiviral approach acts directly against the viral genome to stop the viral replication.