Large Phase 3 Trials to be Announced by GRA and Dr. Reddy’s Laboratories
DUBAI – July 15, 2020 – Healthcare solutions provider Global Response Aid (GRA) said the anti-viral drug Avigan® produced encouraging results in a recent multi-center clinical study led by Japan’s Fujita Health University, showing a discernible trend in reducing fevers and viral loads in early-stage COVID-19 patients.
Fujita Health University’s principle investigator for the study described in a published statement the challenging scenario in which eligible patient recruitment was hindered by reductions in new patient presentations, leading to a limited sample of 89 patients. This ultimately prevented the study from achieving statistical significance, despite the relatively positive trends observed.
The study included two arms. Patients in the first arm received Avigan® early in the progress of their illness; and patients in the second arm, received the drug later than those in the first arm. More than 94% of the patients in the group receiving early treatment with Avigan® had a significant and rapid reduction in viral loads (dropping them below 50%) and alleviation of fevers within 2.1 days on average.
GRA believes these results highlight the drug’s potential to prevent COVID-19 patients from progressing to more severe or critical clinical stages of the disease, along with the possibility of treating patients with mild or moderate cases of COVID-19 in outpatient settings. Additional studies designed to validate these potential uses are currently underway and will represent a breakthrough in the fight against COVID-19 if they yield similar positive results.
“The findings from this university-led study are highly encouraging,” said Mitch Wilson, CEO of GRA. “We will soon be announcing a large, company-sponsored, Phase-3 double-blind randomized clinical trial with up to 1,000 patients.”
Avigan®, which contains the active ingredient Favipiravir, is the subject of clinical studies and 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. Fujifilm is conducting a multi-site Phase 2 trial in the United States involving initially hospitalized patients. Avigan® also is the subject of an investigator-initiated Phase 2 trial in subjects with mild or asymptomatic COVID-19 being conducted by the Stanford University School of Medicine. The drug is also being considered for large-scale testing in a number of countries and we expect the announcement of a second Phase-3 double-blind randomized clinical trial with up to 1,500 patients.
GRA, Dr. Reddy’s Laboratories, and FUJIFILM Toyama Chemical recently entered a global licensing agreement covering the production, marketing and distribution of Avigan®. FUJIFILM Toyama Chemical is a FUJIFILM subsidiary that discovered the active ingredient in Avigan® in the late 1990s for development as an anti-influenza drug.
GRA is a Dubai-based company established by global logistics leader Agility (KSE: AGLTY) 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.
“GRA’s focus is on rapidly determining the safety and effectiveness of Avigan® as a potential treatment for COVID-19,” GRA’s Wilson said. “These studies give us a more expansive breadth of data globally and allow us to evaluate the drug in a short amount of time. The speed with which Avigan® has moved into clinical development for coronavirus reflects the pressing need for treatment options and the shared commitment of industry, governments, global health organizations and healthcare providers to respond to this public health threat with the greatest urgency.”
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.