FDA Grants Fast Track Designation to Remestemcel-L for COVID-19 ARDS Treatment
Key Insights
The FDA has granted Fast Track designation to remestemcel-L for treating acute respiratory distress syndrome (search) (ARDS (search)) due to COVID-19 (search), addressing a critical unmet need.
Clinical data from a pilot study showed that 75% of ventilator-dependent COVID-19 (search) ARDS (search) patients were successfully discharged after remestemcel-L treatment.
A Phase 3 trial is ongoing, evaluating remestemcel-L in up to 300 ventilator-dependent patients with moderate to severe COVID-19 (search) ARDS (search), with mortality as the primary endpoint.
Mesoblast Limited announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for remestemcel-L in the treatment of acute respiratory distress syndrome (search) (ARDS (search)) due to COVID-19 (search) infection. This designation aims to expedite the development and review of therapies addressing serious conditions with limited treatment options.
Clinical Data Supporting Remestemcel-L
Clinical data submitted to the FDA included results from a compassionate use study at Mt. Sinai Hospital in New York. In this study, 9 out of 12 (75%) ventilator-dependent patients with moderate to severe COVID-19 (search) ARDS (search) were successfully discharged from the hospital a median of 10 days after receiving two intravenous doses of remestemcel-L.
Phase 3 Trial Details
The ongoing randomized controlled Phase 3 trial is evaluating remestemcel-L in up to 300 ventilator-dependent patients with moderate to severe COVID-19 (search) ARDS (search). The primary endpoint is overall mortality at Day 30, with a key secondary endpoint being days alive off ventilatory support through Day 60. Interim analyses by the independent Data Safety Monitoring Board (DSMB) recommended continuing the trial as planned.
Collaboration with Novartis
Mesoblast has entered into a license and collaboration agreement with Novartis for the development, manufacture, and commercialization of remestemcel-L, initially focused on treating ARDS (search), including COVID-19 (search) ARDS. The agreement's closing is subject to regulatory approvals.
About Remestemcel-L
Remestemcel-L is an investigational therapy involving culture-expanded mesenchymal stromal cells from an unrelated donor's bone marrow. It is believed to have immunomodulatory properties, counteracting cytokine storms in inflammatory conditions by downregulating pro-inflammatory cytokines, increasing anti-inflammatory cytokines, and recruiting anti-inflammatory cells to affected tissues.
COVID-19 ARDS Context
ARDS (search) results from a dysregulated immune response in the lungs to infectious agents like COVID-19 (search). Mortality rates in COVID-19 ARDS patients over 60 remain high, exceeding 60%, even with improved treatments. These patients often show limited response to corticosteroids and single cytokine antagonists.