Phase 2/3 Randomized Controlled Trial of Remestemcel-L in 300 Patients With COVID-19 Acute Respiratory Distress Syndrome Begins Enrollment

NEW YORK, April 30, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced a Phase 2/3 randomized, placebo-controlled trial to rigorously confirm whether its allogeneic mesenchymal stem cell therapy remestemcel-L provides a survival benefit in moderate/severe acute respiratory distress syndrome (ARDS) due to COVID-19 has commenced enrollment.

More than 20 medical centers across the United States will participate in the trial which is expected to complete enrollment within three to four months, with interim analyses planned which could result in stopping the trial early for efficacy or futility.

Mesoblast Chief Executive Dr Silviu Itescu stated: “There are limited treatment options for ventilator-dependent patients with acute respiratory distress syndrome, the principal cause of mortality in COVID-19 infection. Based on the encouraging initial results of remestemcel-L treatment under emergency compassionate use in New York, there is an urgent need to execute this robust randomized placebo–controlled trial in order to definitively determine whether this cell therapy can reduce the mortality of patients with COVID-19 ARDS on ventilators.”

The specific clinical protocol for use of remestemcel-L in patients in this trial was informed by the previously reported positive results from the emergency compassionate use protocol patients with COVID-19 ARDS. In line with specific guidance provided by the FDA for robust statistical analysis, the placebo-controlled trial will enroll up to 300 ventilator-dependent patients in intensive care units with moderate to severe COVID-19 ARDS randomized (1:1) to receive either two intravenous infusions of remestemcel-L within five days or placebo on top of maximal care. The primary endpoint is all-cause mortality within 30 days of randomization, with the key secondary endpoint being the number of days off mechanical ventilator support. 

Mesoblast Chief Medical Officer Dr Fred Grossman said: “The promising initial results using remestemcel-L in the emergency compassionate use protocol create an imperative for an appropriately-sized definitive randomized controlled trial. We believe the central mechanism by which remestemcel-L modulates the inflammatory process provides a compelling rationale between these results in COVID-19 ARDS and other inflammatory conditions where the cell therapy has shown clinical benefits.”