Antiviral Avigan Moves into COVID-19-based Phase II Clinical Trials in Boston Area

Antiviral Avigan Moves into COVID-19-based Phase II Clinical Trials in Boston Area

Fujifilm Holdings Corp initiated a Phase II clinical trial of its anti-flu drug Avigan for COVID-19 patients in the United States for the first time in the Boston, MA, area involving Brigham and Women’s Hospital, Massachusetts General Hospital, and the University of Massachusetts Medical School. In Japan, the Japanese company launches a Phase III Avigan trial for COVID-19 patients in Japan. The drug has produced mixed results. Boston, the world’s leading life sciences industry cluster, is an appropriate place to evaluate this important investigational treatment for COVID-19 patients.

What is Avigan?

TrialSite News first introduced Avigan and received many direct emails of interest from all over the world. Known as Avigan, it is an antiviral drug under development by Toyama Chemical of Japan with activity against many RNA viruses. The drug was also being assessed in China for experimental treatment of SARS-CoV-2 and was found to be effective in treating the infection in two clinical trials in Wuhan and Shenzhen. Avigan has evidenced activity against influenza viruses, West Nile virus, yellow fever virus, foot and mouth disease, and others.

The Study

The Japanese sponsor selected the world’s leading life sciences industry cluster for the new clinical trial in the Boston area.  This first U.S. clinical trial of Avigan will enroll approximately 50 patients with COVID-19 in collaboration with Brigham and Women’s Hospital, Massachusetts General Hospital and the University of Massachusetts Medical School.

Thus Far No Proof for COVID-19

The study has to hopefully contribute to the breakthrough that it actually can help COVID-19 patients. Thus far, study results have been mixed; in China, there is some positive evidence, while in Japan the evidence has been negligible.

Boston’s NPR station WBUR interviewed John Connor, a virologist at Boston University’s National Emerging Infectious Disease Lab (not involved with the clinical trial), who reported that one key challenge to overcome includes overcoming the “virus’ formidable proofreading system.” As it turns out, coronaviruses often can detect mistakes during replication and actually fix them, noted Connor. But overall, the virologist is upbeat about the drug, noting the overall approach of the drug makes sense reported WBUR. According to Connor, “It’s a small molecule that has been used to treat other respiratory infections, and so it would be nice if it were found to work on this one.”

COVID-19 Phase III Trial in Japan

Toyama Chemical Co., Ltd announced the initiation of a Phase III clinical trial to evaluate the safety and efficacy of “Avigan Tablet” (generic name: favipiravir) in Japan for COVID-19 patients, a respiratory infection caused by the novel coronavirus (SARS-CoV-2).

Approved for Influenza

The drug has been approved by the Japanese drug authorities for manufacture and sale as an influenza antiviral in that nation. The drug, with a mechanism of action for selectively inhibiting RNA polymerase involved in influenza viral replication, the same effect is suspected with COVID-19.

The Drug Sponsor

Fujifilm Toyama Chemical Co., Ltd conducts research, development, manufacturing and sales of radiopharmaceuticals and small molecule pharmaceutical products. Under close cooperation with FUJIFILM Corporation, it aims to develop innovative diagnostic and therapeutic radiopharmaceuticals as well as therapeutic drugs with unique mechanisms of action in the fields of oncology, central nervous system, and infectious diseases where significant unmet medical need still exist. It also works to develop new medicines utilizing drug delivery system (DDS) technologies, designed to deliver the required amount of drug in a timely manner to the specific body area.

Founded in 1934, Fujifilm launched Toyama in 2018 to engage in the research, development, manufacturing and sale of small molecule pharmaceuticals as well as FUJIFIM Pharma Co., Ltd., a company engaged in the research, development, manufacturing and sale of radiopharmaceuticals in order to accelerate the development of diagnostic and therapeutic drugs. The company is led by Kenji Sukeno.