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Dr Reddy’s Laboratories Ltd and Global Response Aid FZCO (GRA) on Wednesday announced the termination of an Avigan Trial Study conducted in Kuwait focussed on moderate to severe Covid patients in a hospital setting.
The hospitalised patient study was one of the studies in the overall clinical programme for Avigan, spanning the spectrum of asymptomatic to severe cases of Covid in both outpatient and in-patient settings.
Avigan is a trademark of Fujifilm Toyama Chemical Co Ltd.
The Phase-III study, being conducted in an outpatient setting on patients with mild to moderate symptoms in North America by Dr Reddy’s, in partnership with Appili Therapuetics and Global Response Aid, shall continue.
“The data from the Kuwait study involving moderate-severe Covid19 hospitalised patients did not show statistically significant difference for the primary endpoint (i.e. time to sustained hypoxia resolution) for Avigan vs placebo,’’ Dr Reddy’s said in a release.
The full data analysis on 353 subjects will be available by the end of February 2021. Within this group, there was a sub group analysis carried out on 181 subjects in the low risk category.
The sub-group analysis demonstrated a three-day earlier release from hospital in the Avigan group compared to the placebo group.
The sub group analysis data during the initial interim analysis points towards the hypothesis with clinically significant insights from this study that an antiviral drug like Avigan may be effective as part of early treatment initiation in Covid-19 patients and not effective in the late-stage hospital treatment for moderate and severe Covid 19 patients, said the release.
Dr Reddy’s, in partnership with Appili Therapeutics and Global Response Aid, shall continue the Phase III pivotal study being conducted in North America in an out-patient setting.
The study aims to determine the efficacy of Avigan as an early treatment for Covid patients with mild-to-moderate symptoms, with the goal of alleviating symptoms and preventing disease progression before the infection requires hospitalisations or other intensive interventions.
Additional observational studies to evaluate efficacy of Avigan as part of early treatment in Coivd patients are also initiated, Dr Reddy’s said.
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