The Food and Drug Administration (FDA) has granted Fast Track designation to remestemcel-L (Mesoblast) for the treatment of acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19).
Remestemcel-L consists of culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is believed to work by down-regulating the production of proinflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.
The designation is supported by results from a pilot study evaluating remestemcel-L in ventilator-dependent COVID-19 patients with moderate to severe ARDS during March and April of 2020 at Mount Sinai hospital in New York City. Findings showed 83% survival in ventilator-dependent COVID-19 patients with moderate/severe ARDS (n=10/12) following 2 intravenous infusions of remestemcel-L within the first 5 days; 75% of ventilator-dependent patients (n=9/12) were successfully discharged from the hospital at a median of 10 days.
The Company is currently investigating remestemcel-L in a randomized controlled phase 3 trial in up to 300 ventilator-dependent COVID-19 patients with moderate to severe ARDS; the trial is approximately two-thirds enrolled. The primary end point is the overall mortality at day 30, and the key secondary end point is days alive off ventilatory support through day 60.
A final interim analysis will be performed by an independent data safety monitoring board (DSMB) once 180 patients have completed 30 days of follow-up; the DSMB recommended the trial continue following interim analyses performed after 90 and 135 patients were enrolled.
For more information visit mesoblast.com.
FDA grants Fast Track designation for remestemcel-L in the treatment of acute respiratory distress syndrome due to covid-19. [press release]. New York, NY: Mesoblast Limited; December 2, 2020.