Mesoblast (ASX:MSB) says the first patients have been dosed in its 300-patient randomised placebo-controlled Phase 2/3 trial in the US of its allogeneic cellular medicine remestemcel-L in COVID-19 infected patients with moderate to severe acute respiratory distress syndrome (ARDS) on ventilator support.
The company said the clinical protocol for the Phase 2/3 trial is based on initial promising results from use of remestemcel-L in patients with moderate to severe COVID-19 ARDS under an emergency IND application or expanded access protocol at The Mount Sinai Hospital in New York.
The trial will randomise up to 300 ventilator-dependent patients in intensive care units to either remestemcel-L or placebo (1:1) on top of maximal care, in line with specific guidance provided by the US FDA.
The primary endpoint is all-cause mortality within 30 days of randomisation, with the key secondary endpoint being the number of days alive and off mechanical support.
The company said the trial will include up to 30 sites across North America. Enrollment is expected to complete within three to four months with interim analyses planned which could result in stopping the trial early for efficacy or futility.
The Clinical and Data Coordinating Center for the trial will be overseen by Dr Annetine Gelijns, Dr Alan Moskowitz and Dr Emilia Bagiella, the co-Directors of the Institute for Transformative Clinical Trials at the Icahn School of Medicine at Mount Sinai.
According to Dr Moskowitz, “This rapid mobilization of major medical centers across the United States reflects the urgent need to treat the very large numbers of people in hospital intensive care units suffering with COVID-19 ARDS and requiring ventilation. We expect quick enrollment in this trial to determine whether remestemcel-L can reduce mortality in these patients.”