Appili Therapeutics said that it has dosed the first participant in the phase 3 PRESECO clinical trial for Avigan tablets (favipiravir) for the oral treatment of Covid-19.
The Canadian infectious disease biopharma company Appili is involving PRA Health Sciences as a clinical research organization (CRO) for administering the Covid-19 clinical trial at 47 outpatient sites.
PRESECO clinical trial is a randomized, double-blind, placebo-controlled study, which will enroll nearly 826 participants. It is the second Covid-19 clinical trial sponsored by Appili Therapeutics that has started dosing this quarter.
The Canadian biopharma company anticipates disclosing early data from the PRESECO clinical trial in the first half of 2021.
Initially, the phase 3 Covid-19 clinical trial of Avigan tablets will be focused in the US but could expand to other regions of the world affected by the pandemic.
Commenting on the PRESECO clinical trial, Dr. Yoav Golan – Chief Medical Officer of Appili Therapeutics, said: “Dosing the first participants in our first Phase 3 trial is a significant milestone as we work to stem the tide of this coronavirus.
“Early intervention with patients before they develop severe COVID-19 and require hospitalization remains a significant unmet need in the COVID-19 treatment landscape.
“As is the case with influenza, we believe that even with effective vaccines, oral antivirals will play a critical role in treating COVID-19 and preventing its progression. Avigan’s pill format and shelf-life stability make it particularly well-suited for this endeavor and we look forward to gathering the necessary data to determine Avigan’s utility for these patients.”
PRESECO expands to Preventing Severe COVID Disease. Its goal is to determine the efficacy of Avigan as a Covid-19 treatment in patients testing positive for the novel coronavirus and having mild-to-moderate symptoms.
Avigan is intended for alleviating symptoms and preventing progression of the disease before the infection demands hospitalizations or other intensive interventions.
Developed by FUJIFILM Toyama Chemical, Avigan has been approved in Japan as a treatment and stockpile countermeasure for pandemic influenza.
In Russia and India, favipiravir based antiviral drugs had been approved for the emergency treatment of Covid-19.
In October 2020, Appili Therapeutics joined a consortium that includes Dr. Reddy’s Labs, FUJIFILM Toyama Chemical and Global Response Aid for the global development and distribution of Avigan tablets for the potential treatment and prevention of Covid-19. Japan, China, and Russia have been excluded by the consortium.
Appili Therapeutics holds key responsibilities for designing and executing the consortium’s global clinical programs and associated work for the potential Covid-19 treatment.
Dr. Armand Balboni – CEO of Appili Therapeutics, commenting on the PRESECO clinical trial, said: “We are fully committed to obtaining robust clinical data that demonstrates how Avigan may best fit into the full spectrum of a global pandemic response by addressing significant unmet needs.
“Providing early access to antiviral therapy is the cornerstone of our clinical strategy. Working with regulatory agencies and our partners, we have chosen to pursue a multi-pronged clinical trial approach, with triggers for treatment that include either a positive COVID diagnosis or known recent exposure to a COVID-19 case.
“Our target patient population includes those in the outpatient setting most vulnerable to the devastating effects of advanced COVID-19 infections, including those over 50, with significant co-morbidities, and front-line workers.”