Global Response Aid (GRA) and Dr. Reddy’s Laboratories stated that the anti-viral drug Avigan produced promising results in a single-blinded, placebo-controlled Phase 3 clinical study conducted in Japan.
The analysis showed patients who received Avigan recovered from COVID-19 symptoms 2.8 days earlier, on average, compared with the control group. The study involved 156 hospitalized patients showing COVID-19 induced pneumonia and divided into two groups. Patients in the first group received Avigan. Patients in the second group received a placebo looking identical to the drug. A statistically significant percentage of the patients in the group receiving Avigan had a rapid reduction in viral loads.
The study aimed to measure recovery from pneumonia and COVID-19 symptoms. It monitored patients’ temperature, oxygen saturation and CT scan imaging of the lungs. Results of the Japan trial suggest the effectiveness of Avigan as a treatment to prevent COVID-19 patients from progressing from mild to more severe or critical stages of the disease, accelerate recovery from COVID-19 symptoms. The drug approved in India, Russia, Indonesia and other countries around the world.
Mitch Wilson, CEO, GRA said: “The findings from this university-led study are the proof we all need to tackle this pandemic. We are actively working with regulators to speed up approval in major markets. As Avigan is manufactured in pill form the drug can be self-administered from home, which reduces the patient load in hospitals and on the medical staff. Furthermore, Avigan does not require refrigerated transport or storage making it easier to quickly distribute the drug to countries and markets with limited cold storage infrastructure.”
Avigan is undergoing testing in the United States in a multi-site Phase 2 study involving initially hospitalized patients, a trial sponsored by FujiFilm Toyama Chemical. It also is the subject of an investigator-initiated Phase 2 study in subjects with mild or asymptomatic COVID-19 conducted by the Stanford University School of Medicine.