- Mesoblast (MSB) has released results from its 60-day trial, which was halted late last year during its third interim analysis
- The company’s remestemcel-L drug has reduced mortality in COVID-19 patients under 65 with moderate to severe acute respiratory distress syndrome
- Results have shown the therapy drug reduced mortality by 46 per cent in the pre-specified group below the age of 65 but not in patients over 65
- As the pandemic and the resulting treatment regimens continued to evolve throughout the trial, the referral pool of patients into the trial became progressively older, causing the median age in the trial to increase from 59 in the first half to 67 in the second half
- Mesoblast says this could have impacted the outcome of the third interim analysis but still believes it is possible that to achieve mortality reduction in patients over 65 with different dosages
- Mesoblast will now organise a meeting with the U.S. Food and Drug Administration (FDA) to discuss the potential next steps
- Company shares last traded at $1.83
Mesoblast (MSB) has seen its remestemcel-L drug reduce mortality in patients under 65 with COVID-19.
The company has released results from its 60-day trial of remestemcel-L in 222 ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS), despite the study being halted after the third interim analysis, late last year.
Results have shown the therapy drug reduced mortality, over 60 days, by 46 per cent in the pre-specified group below the age 65 but not in patients over 65.
Additionally, paired with dexamethasone, remestemcel-L reduced mortality by 75 per cent and increased the number days alive off mechanical ventilation in patients under age 65.
As the pandemic and the resulting treatment regimens continued to evolve throughout the trial, the referral pool of patients into the trial became progressively older, causing the median age in the trial to increase from 59 in the first half to 67 in the second half.
Mesoblast believes this could have impacted the outcome of the third interim analysis which resulted in the trial’s early conclusion.
“It is possible that to achieve mortality reduction in patients over 65 with comorbidities will require a different dosing regimen than that which may be effective in patients under 65,” the company explained.
“Reduction in mortality in mechanically ventilated patients under 65 years old remains a critical unmet need since as many as 72 per cent of currently hospitalised patients across the U.S. with COVID-19 are in this age category,” CEO Silviu Itescu said.
“This is similar to other causes of viral ARDS such as influenza where 70-80 per cent of patients in intensive care units are under 65. The reduction in mortality seen with remestemcel-L in this age group highlights the potential to make a meaningful difference in the treatment of diseases of excessive inflammation,” he added.
Mesoblast will now organise a meeting with the U.S. Food and Drug Administration (FDA) to discuss the potential next steps.
Just before the market opens this morning, Mesoblast is trading at $1.83 per share.