Hyderabad: Hyderabad-based pharmaceuticals company, Dr Reddy’s Laboratories said it has terminated Avigan trial study being conducted in Kuwait that was focused on moderate to severe Covid-19 patients in a hospital setting.
It was one of the studies in the overall clinical programme for Fujifilm’s Avigan, an antiviral medication, spanning the spectrum of asymptomatic to severe cases of Covid-19 in both outpatient and inpatient settings.
The Phase-III study, being conducted in an outpatient setting on patients with mild to moderate symptoms in North America by the company in partnership with Appili Therapeutics and Global Response Aid, shall continue, the company said.
The data from the Kuwait study involving moderate-severe Covid-19 hospitalised patients did not show statistically significant difference for the primary endpoint. The full data analysis on 353 subjects would be available by the end of February 2021, it added.
Dr Reddy’s said sub-group analysis was carried out on 181 subjects in the low risk category. The sub-group analysis of the low-risk category demonstrated a three-day earlier discharge in the Avigan group compared to the placebo group for time to hospital discharge secondary endpoint.
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.
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