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.Mesoblast is engaged in the development of regenerative medicine products. Co. has leveraged its proprietary technology platform, based on specialized cells known as mesenchymal lineage adult stem cells ("MLCs"), to establish a portfolio of late-stage product candidates. Co.'s allogeneic, "off the shelf" product candidates target advanced stages of diseases with high, unmet medical needs including cardiovascular conditions, orthopedic disorders, immunologic and inflammatory disorders and oncology and hematologic conditions. Each MLC-derived product candidate has technical characteristics, target indications, reimbursement strategy, commercialization potential, and partnering opportunities.
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