Study for hospitalized moderate to severe cases in Kuwait terminated, while study for out-patient mild to moderate cases continues in North America
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY along with its subsidiaries together referred to as “Dr. Reddy’s”) and Global Response Aid FZCO (GRA) today 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 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. 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.
Dr.Reddy’s, in partnership with Appili Therapuetics and Global Response Aid, shall continue the Phase 3 pivotal study [PRESECO] being conducted in North America in an out-patient setting. The PRESECO 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 hospitalizations or other intensive interventions. Additional observational studies to evaluate efficacy of Avigan as part of early treatment in COVID 19 patients are also initiated.
Avigan® is a trademark of FUJIFILM Toyama Chemical Co., Ltd.