Completed Phase 3 clinical study paves way for approval request
DUBAI — September 23, 2020 – Healthcare solutions provider Global Response Aid (GRA) and Dr. Reddy’s Laboratories (NYSE: RDY) announced that the anti-viral drug Avigan® produced promising results in a single-blinded, placebo-controlled Phase 3 clinical study conducted in Japan with the sponsorship of FujiFilm Toyama Chemical.
Patients who received Avigan® recovered from COVID-19 symptoms 2.8 days earlier, on average, compared with the control group. Analysis showed patients had a statistically significant higher probability to recover when administered Avigan® compared with the patients not receiving the drug.
The study involved 156 hospitalized patients showing COVID-19 induced pneumonia, and divided in two groups or “arms.” Patients in the first arm received Avigan®. Patients in the second arm 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. Time-to-alleviation of the symptoms was measured between the first administration of the drug (or placebo) and the moment when SARS-COV-2 induced symptoms became undetectable.
Shortening recovery time lowers the risk of complications in patients and, importantly, significantly reduces the risk that a patient will spread the virus. The latest results open the possibility of treating patients with mild or moderate cases of COVID-19 in outpatient settings, which also could help slow the spread of the pandemic.
Avigan®, which contains the active ingredient Favipiravir, was developed by FujiFilm Toyama Chemical in the 1990s as an anti-influenza drug. GRA, Dr. Reddy’s Laboratories, and FujiFilm Toyama recently entered a global licensing agreement covering the production, marketing and distribution of Avigan®.
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 clinical stages of the disease, and to accelerate recovery from COVID-19 symptoms.
GRA CEO Mitch Wilson said the FujiFilm Toyama study represents a breakthrough in the fight against COVID-19, and opens the way for approval of Avigan® as a COVID-19 treatment in Japan. The drug is already approved in India, Russia, Indonesia and other countries around the world.
“The findings from this university-led study are the proof we all need to tackle this pandemic,” Wilson said. “We are actively working with regulators in order to speed up the approval in major markets. Because Avigan® is manufactured in pill form the drug can be self-administered from home, which reduces patient load in hospitals and on medical staff. Furthermore Avigan® does not require refrigerated transport or storage making it much easier to quickly distribute the drug to countries and markets with limited cold storage infrastructure”
Avigan® is the subject of clinical trials in COVID-19 patients in several countries. It was used to treat COVID-19 patients in studies in China’s Hubei province, led by the China-Japan Friendship Hospital. It 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 being conducted by the Stanford University School of Medicine.
Avigan® Tablet was approved for manufacture and sale in Japan in 2014 as an influenza anti-viral drug. The drug is to be considered for use only when there is an outbreak of novel or re-emerging influenza virus infections in which other influenza anti-viral drugs are either not effective or insufficiently effective, and the Japanese government decides to use the drug as a countermeasure against such influenza viruses. GRA is a Dubai-based company established by global logistics leader Agility (KSE: AGLTY) and AiPHARMA a biotechnology company to procure and develop certified diagnostic, testing and protective products and services used in the detection, treatment and prevention of COVID-19 and other public health threats.