Key takeways from recent study of Remestemcel-L:

• Remestemcel-L significantly reduced mortality by 48% at 90 days compared to controls in a pre-specified analysis of 123 treated patients under 65 years old.
• This compares favourably with the 46% mortality reduction reported at 60 days.
• Remestemcel-L was even more effective when evaluated in an exploratory analysis in patients on dexamethasone as part of their standard of care, with 90-day mortality being reduced by 77% compared to controls under 65 who received dexamethasone.
• Despite a treatment-related improvement in respiratory function at day 7, there was no mortality reduction in the 97 treated patients over age 65.

The company says they will be meeting with the FDA to discuss these benefits for people under the age of 65. They have also entered into a license and collaboration agreement with Novartis to develop, manufacture and commercialize Remestemcel-L, with an initial focus on the treatment of acute respiratory distress syndrome (ARDS), which is a syndrome associated with COVID-19. This agreement is still pending more results from the COVID-19 ARDS trial study.

All in all things are looking positive for this drug, but as we all know with the pharmaceutical industry, things can change very quickly so still holding my breath and waiting for announcements on final agreements on the drug. Will be interesting what the FDA is willing to approve and what conditions they are willing to approve the drug for also.

Full ASX Announcement from Mesoblast