Mesoblast has reported that its therapy, remestemcel-L, enhanced survival outcomes in ventilator-dependent Covid-19 patients suffering from moderate/severe acute respiratory distress syndrome (ARDS) in a trial.
The randomized, controlled trial enrolled a total of 222 subjects in the US.
Of these subjects, 217 were categorized in a 1:1 ratio to receive either two intravenous doses of remestemcel-L administered three to five days apart plus standard of care alone (SOC) or SOC alone.
Data from a pre-specified analysis of 123 subjects aged under 65 years showed that remestemcel-L decreased mortality by 48% at 90 days versus controls. This is comparable to the 46% decrease in mortality at 60 days, suggesting a durable therapeutic effect, the company noted.
In an exploratory analysis involving subjects on dexamethasone, the drug candidate led to a 77% reduction in mortality when compared to controls aged below 65 years on dexamethasone.
Furthermore, significant improvements with remestemcel-L were observed on secondary endpoints of ventilator-free days, respiratory function determined by ARDS severity and overall clinical improvement on a seven-point ordinal scale.
On day seven, the therapy enhanced respiratory function in subjects above 65 years, but 97 treated participants did not experience a decrease in mortality.
Furthermore, remestemcel-L, along with SOC of dexamethasone, boosted respiratory function and improved clinical outcomes to an increased extent in subjects under 65 at days seven, 14, 21, and 30.