Dr Reddy's Laboratories Ltd and Global Response Aid FZCO (GRA) on Wednesday announced the termination of Avigan (antiviral drug) trial study conducted in Kuwait focused on moderate to severe Covid patients in a hospital setting.
The hospitalised patient study, conducted in Kuwait, on moderate to severe patients 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 setting.
The Phase 3 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 GRA, will continue, the Hyderabad-based pharma major said.
The data from the Kuwait CVD-04-CD-001 study involving moderate-severe Covid-19 hospitalised patients did not show statistically significant difference for the primary endpoint for Avigan vs Placebo. The full data analysis on 353 subjects would 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, and it demonstrated a 3 day earlier discharge in Avigan group compared to placebo group for time to hospital discharge secondary endpoint.
Presco study aims to determine the efficacy of Avigan as an early treatment for Covid-19 patients
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.
Dr Reddy's, in partnership with Appili Therapuetics and Global Response Aid, shall continue the phase 3 pivotal study being conducted in North America in an out-patient setting. The Presco study aims to determine the efficacy of Avigan as an early treatment for Covid-19 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 Covid-19 patients are also initiated, it added.
