Appili announces dosing of first patient in phase 3 Covid-19 trial

Appili Therapeutics announced that first patient has been dosed in the phase 3 PRESECO (preventing severe Covid disease) clinical trial to assess oral Avigan tablets (favipiravir) to treat Covid-19.

PRA Health Sciences, a clinical research organisation (CRO) selected by Appili, will conduct the trial at 47 outpatient sites.

Avigan, which is an antiviral in oral tablet form developed by FUJIFILM Toyama Chemical, already secured approval in Japan as a treatment and stockpile countermeasure for influenza.

Based on promising clinical studies, Russia and India have approved favipiravir-based antiviral medications as emergency treatment for Covid-19.

The PRESECO study will evaluate the efficacy of Avigan as a treatment for Covid-19 in patients with a positive Covid-19 test and mild-to-moderate symptoms. It aims to alleviate symptoms and prevent disease progression before the infection needs hospitalisations or other intensive interventions.

The current randomised, double-blind and placebo-controlled study will recruit up to 826 participants. It is the second Appili-sponsored Covid-19 clinical trial, which has begun dosing this quarter.

Initially, Appili intends to conduct the trial in the US and plans to expand the programme to other areas across the world affected by Covid-19.

Appili is sponsoring three randomised, double-blind and placebo-controlled clinical trials to assess the safety and efficacy of Avigan tablets in outpatients in various Covid-19 indications.

Appili’s two other trials include phase 3 PEPCO (post exposure prophylaxis for Covid-19) study designed to assess Avigan in preventing the development of Covid-19 when administered to asymptomatic individuals who have had direct exposure to an infected person.

In addition, the phase 2 CONTROL trial is assessing the use of Avigan to control outbreaks of Covid-19 in Canadian long-term care facilities.

Appili Therapeutics CEO Dr Armand Balboni said: “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.”

In May this year, Appili Therapeutics secured regulatory clearance from Health Canada to move ahead with a phase 2 study for studying favipiravir as a preventative measure against the outbreak of novel coronavirus (Covid-19).