Dr. Reddy's (RDY) and GRA Announce Clinically Meaningful Data from Avigan Pivotal Studies
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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 results from an Avigan study on moderate-severe hospitalized COVID-19 patients in Kuwait.
A 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. This endpoint was predefined and showed statistical significance in a large portion of subjects in this study. Time to hospital discharge is the best endpoint to determine if Avigan has a pragmatic effect on patients' duration of hospitalization, a factor that is relevant to global shortages in clinical resources and hospital beds induced by the global COVID-19 pandemic.
The findings point favorably towards the hypothesis that an antiviral drug like Avigan (or similar oral or injectable RNA polymerases inhibitor) may be effective as part of early treatment initiation in COVID-19 patients.
As a result of the favorable sub-group data, which are supported by similar results in Japan-based clinical trials and real-world studies, Dr.Reddy's and Global Response Aid have agreed to expedite ongoing Phase 3 pivotal studies aimed at determining the efficacy of Avigan as an early treatment for COVID-19 patients with mild-to-moderate symptoms. Additional studies to evaluate the efficacy of Avigan as part of early treatment in COVID-19 patients have also been initiated, with the goal of alleviating symptoms and preventing disease progression before the infection requires hospitalization or other intensive interventions.
Other findings from the study of hospitalized patients with moderate-severe COVID 19 patients showed a one-day reduction in time to sustained hypoxia resolution for Avigan vs. placebo. Resolution occurred in seven days vs. eight days. However, the study did not achieve statistical significance thresholds, and was terminated. The full final data analysis of the 353 subjects who were part of the study of hospitalized patients will be available by end of February 2021.
The study of hospitalized patients was part of an overall clinical program for Avigan in Kuwait, which covered a spectrum of COVID-19 cases ranging from asymptomatic to severe, in both outpatient and in-patient settings.
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