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Sunday, April 25, 2021 9:32:56 PM
"Mesoblast Fails to Meet Primary Endpoint in COVID-19 Trial; Dec.20,2020
Mesoblast, on Friday, reported a failure in achieving the 30-day mortality reduction endpoint during its COVID-19 ARDS (acute respiratory distress syndrome) trial. However, no safety concerns were noted during the trial. Shares plunged 32% in after-hours trading.
Mesoblast (MESO) is a regenerative medicine company based in Australia.
The trial featured 300 patients, targeting a 43% reduction in mortality at 30 days, for treatment with remestemcel-L in addition to maximal care.
Remestemcel-L is an investigational therapy involving culture-expanded MSCs (Mesenchymal stem cells) derived from the bone marrow of an unrelated donor."
The company disclosed that 223 patients have completed the trial. They will be kept under observation for 60 days to analyze the impact of the treatment on the secondary endpoints. The endpoints include mortality rate without mechanical ventilation, intensive care and hospitalization duration, organ damages, and other requisite evaluations.
The above outcomes will be analyzed by Mesoblast and Novartis (NVS) in order to come to a conclusion regarding the relevance of remestemcel-L in the treatment of non-COVID ARDS.
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