Mesoblast - COVID-19 ARDS Phase III readout later this year

Mesoblast has initiated a 300-patient randomized, controlled Phase III trial of remestemcel-L (Ryoncil for the acute graft versus host disease (aGvHD) indication) in COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS) who are on ventilator support. The primary endpoint is all-cause mortality up to 30 days post randomization. Recruitment is expected to complete in three to four months, although there are three interim analyses (after 30%, 45% and 60% enrolment) where the trial can be stopped early for efficacy or futility. Based on this, we expect a readout some time in H220, closer to the end of the year if the trial is not halted at an interim analysis.