Mesoblast Limited (Nasdaq:MESO) shares were plunging -30.07 to $9.45 in the premarket session recently released an update on the clinical trial of remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) caused by infection with COVID-19 following a third interim analysis of the first 180 patients in the trial by the Data Safety Monitoring Board (DSMB).
A primary endpoint of 43 percent decrease in mortality at 30 days for treatment with remestemcel-L in addition to maximum care was achieved in the trial of 300 patients. This projected reduction in mortality was centred on pilot information collected during the initial stages of the pandemic, where the control mortality rates in ventilated patients were excessively high and prior to the new evolution of treatment regimens which reduced mortality.
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The DSMB confirmed that there were no safety risks and mentioned that at the planned 300 patient enrollment, the trial is not able to suit the 30-day mortality decrease endpoint. The DSMB suggested that the study be completed with the 223 patients currently enrolled and that all be monitored as planned.
The trial has not garnered any data on the secondary endpoints, which consist of days alive off mechanical ventilation 60 days post randomization, overall survival, days in intensive care, length of hospitalization, and cardiac, neurological, and pulmonary organ impairment. Furthermore, circulating cytokines and markers of inflammation will be evaluated.