Fujifilm’s Phase II US trial of Avigan recruits ten out of 50 hospitalised Covid-19 patient target

GlobalData Healthcare 29th April 2020 (Last Updated April 30th, 2020 08:01)

Fujifilm’s Phase II US trial of Avigan recruits ten out of 50 hospitalised Covid-19 patient target

by Reynald Castaneda in London.

Fujifilm Toyama Chemical’s US-based Phase II trial investigating Avigan (favipiravir) in hospitalised Covid-19 patients has recruited ten out of its 50-patient target, a source familiar with the trial said. The aim is to close enrolment this month, he added.

While recruitment is expected to complete on time, the source noted a potential logistical challenge is the trial’s (NCT04358549) follow-up period: patients are required to do on-site visits to allow for nasal swabs, but those who drop out due to this trial design element would affect outcomes, he added.

Phase II patients are dosed with Avigan for 14 days, with a 46-day follow-up, ClinicalTrials.gov shows. It has a primary endpoint of time to viral clearance within a 29-day timeframe. Nasopharyngeal and oropharyngeal samples are required to determine SARS-CoV-2 infection.

Avigan, which is approved in Japan for influenza, has shown some positive efficacy signals from two investigator-led, China-based Covid-19 trials. In facton 15 April, Fujifilm announced it had expanded its manufacturing capacity for the drug. It expects up to 100,000 treatment courses to be available by July, ramping up to 300,000 courses by September.

The Japanese government has announced plans to stockpile two million courses. As of 28 April, there are 13,614 confirmed cases of Covid-19 in Japan with 385 deaths, as per Johns Hopkins data. Avigan is also in a Fujifilm-sponsored, Japan-based Phase III trial recruiting 96 Covid-19 patients with nonsevere pneumonia (JapicCTI-205238).

The US-based trial, which is recruiting from three sites and is comparing Avigan plus standard-of-care (SOC) versus SOC, enrolled its first patient on 17 April, and the estimated primary completion date is August, as per ClinicalTrials.gov. Patients in the Avigan arm receive a 1,800mg twice-daily dose (BID) on the first day, followed by 1,000mg BID for days 2–14 or 800mg BID for those with Child-Pugh A liver impairment. Avigan is a broad-spectrum inhibitor of viral RNA polymerase. SARS-CoV-2 is a single-stranded RNA virus.

Fujifilm Toyama Chemical, part of Fujifilm, did not respond to a request for comment by press time. Fujifilm has a $24.7m market cap.

Reynald Castaneda is a Senior Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.