Mesoblast Ltd. (NASDAQ: MESO) shares more than doubled on Friday after the company provided an update on its COVID-19 treatment. While the numbers from this update are impressive, there could be some issues with the study.
Specifically, the company 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.
Also, 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.
Note that these numbers are very impressive in terms of patients getting off ventilators. However, the sample size for this study is incredibly small: only 12 patients. Note that small sample sizes don’t necessarily provide accurate statistics, a single standard deviation could turn this study negative quickly. While the numbers are positive, they should be taken with a grain of salt.
Dr. Silviu Itescu, Mesoblast CEO, commented:
The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled Phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.
Mesoblast stock traded up about 156% to $16.50 on Friday, in a 52-week range of $3.12 to $20.57. The consensus price target is $13.96.
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