Bonus Biogroup (BONS), a late-stage biotechnology company, on Thursday announced that it has received U.S. FDA clearance for its Investigational New Drug or IND application to proceed with a Phase III clinical study of MesenCure.
This study will evaluate the efficacy and safety of MesenCure, an enhanced allogeneic cell therapy consisting of adipose tissue-derived mesenchymal stromal cells or MSC, in treating respiratory distress in severely ill patients, particularly those suffering from pneumonia related to COVID-19.
Bonus Biogroup is working to expand the study to include acute respiratory distress syndrome or ARDS, with findings from Phase II clinical trials showing promising results such as a 68 percent reduction in 30-day all-cause mortality and a 57 percent decrease in invasive ventilation needs among treated patients.
The company estimates MesenCure's market potential in treating all-cause ARDS in the U.S. could reach $9.6 billion by 2030.
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