Mesoblast hit as stem-cell therapy not likely to meet target for reducing Covid mortality

 

• Mesoblast (NASDAQ:MESO) slumps 32% after-hours after an update on remestemcel-L trial in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19.
• Data Safety Monitoring Board (DSMB) performed a third interim analysis on the trial’s first 180 patients.
• The trial was powered to achieve a primary endpoint of 43% reduction in mortality at 30 days for treatment with remestemcel-L on top of maximal care in a trial of 300 patients.
• During the initial stages of the pandemic, control mortality rates were exceedingly high and prior treatment regimens have reduced disease mortality in ventilated patients.
• DSMB noted that the trial is not likely to meet the 30-day mortality reduction endpoint at the planned 300 patient enrolment. However, there were no safety concerns.
• The DSMB recommended that the trial complete with the currently enrolled 223 patients, and that all be followed-up as planned.
• Notably, the trial has not yet accrued data on the secondary endpoints. Additionally, measures of circulating cytokines and inflammatory markers will be evaluated.
• Mesoblast and Novartis (NYSE:NVS) will both analyze these results to identify meaningful clinical outcomes that may guide decisions on the development program for remestemcel-L in non-COVID ARDS.
• On November 2020, Mesoblast collaborated with Novartis to develop COVID-19/ARDS stem cell therapy.
• https://seekingalpha.com/news/3645598-mesoblast-shares-plunge-32-after-stem-cell-therapy-not-likely-to-meet-target-for-reducing