Dr. Reddy stops Avigan study in Kuwait

Hyderabad: Dr. Reddy's Laboratories Ltd and Global Response Aid FZCO (GRA) on Wednesday announced the termination of Avigan Trial Study conducted in Kuwait focused on moderate to severe Covid patients in a hospital setting. 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. 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 CVD-04-CD-001 study involving moderate-severe Covid-19 hospitalized patients did not show statistically significant difference for the primary endpoint (i.e. time to sustained hypoxia resolution) for Avigan versus 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.

Within this group, there was sub group analysis carried out on 181 subjects in the low risk category. The Sub-group analysis of the low-risk (low NEWS Score at admission) study cohort (n=181) demonstrated a 3 day earlier discharge in Avigan group compared to placebo group (8 days vs 11 days; p=0.0063) 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.