83% Survival in COVID-19 Patients with Moderate/Severe Acute Respiratory Distress Syndrome Treated in New York with Mesoblast’s Cell Therapy Remestemcel-L

Key points: 

• 83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated with two infusions of Mesoblast’s allogeneic cell therapy remestemcel-L within the first five days under emergency compassionate use at New York City’s Mt Sinai hospital during the period March-April 2020

• 75% (9/12) have successfully come off ventilator support within a median of 10 days 

• These results contrast with only 9% of ventilator-dependent COVID-19 patients being able to come off ventilators with standard of care treatment and only 12% survival in ventilator-dependent COVID-19 patients at two major referral hospital networks in New York during the same time period^1,2 

• This compassionate use treatment experience has informed the design of the clinical protocol for the randomized, placebo-controlled Phase 2/3 trial of remestemcel-L in ventilator-dependent COVID-19 moderate/severe ARDS patients across North America 

NEW YORK, April 24, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced 83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated during the period March-April 2020 with two intravenous infusions of Mesoblast’s allogeneic mesenchymal stem cell product candidate remestemcel-L within the first five days. 75% (9/12) have successfully come off ventilator support at a median of 10 days. At this time, seven have been discharged from the hospital. Patients received a variety of experimental agents prior to remestemcel-L. All patients were treated under an emergency Investigational New Drug (IND) application or expanded access protocol at New York City’s Mt Sinai hospital.

In contrast, only 9% (38/445) of ventilator-dependent COVID-19 patients at a major referral hospital network in New York City were able to come off ventilator support when treated with standard of care during March/April 2020.¹ Moreover, there was 88% mortality with only 12% survival (38/320) among ventilator-dependent COVID-19 patients at a second major referral hospital network in New York City during the same period.² These poor outcomes are consistent with earlier published data from China where mortality rates of over 80% were reported in patients with COVID-19 and moderate/severe ARDS.³