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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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 fact, on 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).

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.