Pharma company begins final stages of human trials for its coronavirus drug
In a major development, a Japanese pharmaceutical company has started final stages of human trial for its antiviral flu drug to treat COVID-19.
According to the details, Fujifilm’s pharmaceutical branch, Toyama Chemical, on Tuesday announced that it was conducting phase-III trials for its antiviral flu drug ‘Avigan’ for treating coronavirus.
Avigan is approved in Japan for stopping the flu virus from replicating in the body.
Researchers with the company think it may well have the same antiviral effect against the virus that causes COVID-19, Mail Online reported.
Avigan, also known by its generic name, favipiravir, has already fared well in its first two rounds of clinical testing, and Fujifilm has ramped up its production of the drug in anticipation that it could be the first proven treatment for the infection that’s sickened more than 164,000 people worldwide.
Virus particles don’t have the complex structure of human or animal cells that allow the latter to make their own energy. Instead they infect and piggy-back on our cells.
They use this siphoned energy to copy their own genetic material and replicate, a simpler version of reproduction.
As the virus multiplies, the infection spreads throughout the body and overtakes the host.
Avigan works by running interference on an enzyme called RNA polymerase that acts as a catalyst for this process of viral copy-making.
So far, it’s been approved by the Japanese equivalent of the Food and Drug Administration (FDA) to treat the flu, a common but deadly viral respiratory infection that kills some 500,000 people worldwide each year.
Researchers tried Avigan’s generic, favipiravir (as well as a copycat drug) against Ebola.
It looked to be effective when they tested it in mice, but remains unproven.
In studies of humans, Ebola patients treated with Avigan fared better than did those who were in the control group.
Now, the company hopes the drug could work similarly against the current pandemic of coronavirus to how it interrupts the more common respiratory virus, flu.
Results from Fujifilm’s earlier testing were promising enough for it to move ahead into its current phase III trial.
The first phase of clinical trials are merely to make sure a therapeutic safe and that its side effects don’t do more harm than the drug does good.
In second phase trials, the researchers test both safety and efficacy by dosing some patients with the experimental drug and the other half of the study subjects – of whom there are usually hundreds – receive either a placebo drug or the standard treatment.
The experimental drug needs to show at least evidence that it’s safe and has activity that may be giving patients a benefit.
Drug companies then can go to the third phase of testing, which typically involves hundreds or thousands of subjects.
So just by getting to this third phase, Avigan has already performed well in terms of safety.
It will be the larger set of data from the trial that began Tuesday that could get the drug approved for treating coronavirus.
Like the malaria drug being tested in the US, hydroxychloroquine, Avigan has the benefit of already being approved for other uses, meaning it will be available much more quickly than would be a wholly new, targeted treatment for coronavirus could be.
Fujifilm is already looking ahead to that possibility, and ordered an increase in production for Avigan in early March.
And it says that, pending approval to do so, Avigan will be distributed not just in Japan but around the world.
‘Fujifilm intends to sincerely cooperate with the supply of Avigan to such countries in consultation and coordination with the Japanese government to combat COVID-19 and contribute to tackling the spread of this global pandemic at the earliest possible stage,’ the company said in a press release.
Typically, phase II trials can take years, but amid the pandemic government regulators around the world have been expediting drugs like Avigan, shortening that timeline to as little as a matter of months and perhaps weeks, as the US FDA has done in some cases.