Health Canada has approved Appili Therapeutics’ application to begin Phase 3 trials for tablets that should help prevent COVID-19 in people exposed to the disease.
The Halifax-based drug discovery company issued a statement Tuesday saying it had initiated its tests to evaluate Avigan, the name of a tablet that contains Favipiravir, a broad-spectrum antiviral that Appili has licenced from Fujifilm Toyama of Japan. Appili also expects to begin Phase 3 trials in the U.S. soon after the Food and Drug Administration allowed it to submit an amendment to its application.
“Addressing infections and spread early in the community setting remains a particular unmet need for COVID-19, and that is the cornerstone of our clinical strategy,” said Appili CEO Armand Balboni in a statement. “Since Avigan comes in a pill form, it allows for easier administration than other approaches, which usually require injections or intravenous administration, and also enables patients to receive it early after exposure.”
The main objective of the study is to determine if Avigan is safe and effective in preventing COVID-19 among vulnerable people who have recently been exposed to confirmed COVID-19 cases.
Appili has hired CATO Research LLC, a clinical research organization, to administer the trial in Canada and the U.S.
This is the second Phase 3 study Appili has announced to evaluate Avigan tablets in the fight against COVID-19 in a community setting. The other study is evaluating Avigan for the treatment of adults with mild-to-moderate symptoms of COVID-19.
The latest study is a “double-blinded, placebo-controlled, randomized, multinational, Phase 3 clinical trial”, said Appili. About 1,156 participants will join the trial through 47 medical centers, and these participants will include people living in assisted living facilities.