Hyderabad based Dr. Reddy’s Laboratories on Wednesday announced the termination of Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID-19 patients.
The hospitalized patient study, conducted in Kuwait, on moderate to severe patients was one of the studies in the overall clinical program for Avigan, spanning the spectrum of Asymptomatic to severe cases of Covid in both outpatient and in-patient setting.
However, the company said that it will continue ten Phase-III studies in an ‘outpatient setting on patients with mild to moderate symptoms' in North America with its partner with Appili Therapeutics and Global Response Aid.
The data from the Kuwait CVD-04-CD-001 study involving moderate-severe Covid-19 hospitalized patients did not show a statistically significant difference for the primary endpoint (i.e. time to sustained hypoxia resolution) for Avigan vs. Placebo (7 days vs 8 days; p= >0.05).
"The full data analysis on 353 subjects would be available by the end of February 2021," said the company in a statement.
The subgroup analysis data during the initial interim analysis points towards the hypothesis with clinically significant insights that an antiviral drug like Avigan may be effective as part of early treatment initiation in coronavirus patients and not effective in the late-stage hospital treatment for moderate and severe coronavirus patients.
Avigan (favipiravir) drug is an antiviral influenza drug of Japan’s FUJIFILM Toyama Chemical Co., Ltd.
Story Source: https://www.indiatoday.in/india/story/coronavirus-dr-reddy-s-lab-terminates-trial-study-of-avigan-in-kuwait-1763397-2021-01-28