Biopharma firm Appili Therapeutics has announced the dosing of the first participant in its Phase III trial analysing oral Avigan tablets (favipiravir) for treating Covid-19 in the US.
Developed by FUJIFILM Toyama Chemical , Avigan is a broad-spectrum antiviral oral tablet.
PRA Health Sciences has been engaged as the clinical research organisation (CRO) to carry out the trial at 47 outpatient sites, Appili noted.
The Phase III Preventing Severe COVID Disease (Preseco ) study will evaluate the efficacy of Avigan for treating patients with confirmed Covid-19 and mild-to-moderate symptoms.
It plans to alleviate symptoms and prevent disease progression before the infection requires hospitalisations or intensive interventions.
The randomised, double-blind, placebo-controlled study will have around 826 participants.
This is the second Appili-sponsored Covid-19 trial that has started dosing in the current quarter of the year.
Early data from the PRESECO study is expected in the first half of next year.
Currently, Appili is enrolling subjects for the trial in the US and may expand the programme to other areas across the world affected by Covid-19.
Appili Therapeutics chief medical officer Dr Yoav Golan said: “Dosing the first participants in our first Phase III 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 hospitalisation remains a significant unmet need in the Covid-19 treatment landscape.”
“Avigan’s pill format and shelf-life stability make it particularly well-suited for this endeavour and we look forward to gathering the necessary data to determine Avigan’s utility for these patients.”
Appili’s Covid-19 clinical programme includes Phase III PEPCO study analysing Avigan in preventing Covid-19 and Phase II CONTROL study analysing the use of Avigan as a preventative measure against Covid-19 outbreaks in long-term care (LTC) facilities.