The EUA was granted based on data from the phase 3 ACTT-2 trial, which was conducted by the NIAID.
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The FDA has approved the Investigational New Drug (IND) application for the phase 2a study of opaganib (RedHill Biopharma) in patients with confirmed moderate to severe SARS-CoV-2 infection.
The placebo-controlled ACTT 3 trial will evaluate the efficacy and safety of remdesivir in combination with interferon beta-1a in more than 1000 hospitalized COVID-19 patients.
The approval was based on data from the phase 3 ACTT-2 and COV-BARRIER studies.
The studies evaluated routine clinical practice data from more than 800 hospitals in the US.
Both randomized, placebo-controlled trials are expected to enroll approximately 1000 hospitalized patients.
Findings showed that the trial did not meet statistical significance on the primary endpoint.
Following clearance of an Investigational New Drug Application by the Food and Drug Administration, ViralClear announced that a phase 2 study evaluating merimepodib oral solution for the treatment of coronavirus disease 2019 (COVID-19) will be initiated.
The FDA approved Veklury (remdesivir; Gilead Sciences) for the treatment of COVID-19 in patients aged ≥12 years (weighing ≥40kg) requiring hospitalization.
The ACTT-2 study began on May 8 and included more than 1000 patients.