Acalabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, appears to reduce respiratory distress as well as the hyperinflammatory immune response associated with coronavirus disease 2019.
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The EUA was granted based on data from the phase 3 ACTT-2 trial, which was conducted by the NIAID.
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.
Baricitinib, a JAK inhibitor, is currently approved in the US for rheumatoid arthritis.
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.
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 ACTT-2 study began on May 8 and included more than 1000 patients.
The sBLA is supported by data from 4 randomized, controlled studies that evaluated tocilizumab for the treatment of COVID-19 in more than 5500 hospitalized patients.