Benzinga | Apr 30, 2021 09:21AM EDT

Mesoblast Shares Rise As Remestemcel-L Cuts Mortality In Patients Below 65 Years With COVID-19 Related Respiratory Distress

* Mesoblast Limited (NASDAQ: MESO) has announced 60-day results from the randomized controlled trial of remestemcel-L in COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS), which had been halted after the third interim analysis, as previously announced.

* The trial enrolled 222 mechanically ventilated COVID-19 patients.

* Remestemcel-L reduced mortality by 46% through day 60 in the pre-specified population of 123 treated patients under age 65, 26% vs. 42%, Hazard Ratio (HR) 0.54.

* The treatment has similar effects on mortality in these patients with either moderate ARDS (HR 0.56) or severe ARDS (HR 0.56).

* The standard of care changed during the course of the trial to incorporate dexamethasone.

* Remestemcel-L reduced mortality through day 60 by 75% compared to controls in patients under 65 who received dexamethasone as part of their standard of care, 14% vs. 45%, HR 0.25.

* Remestemcel-L increased days alive off the ventilator within 60 days and reduced time to discharge from initial hospitalization compared to controls in patients under 65 who received dexamethasone.

* Mesoblast entered into a license and collaboration agreement with Novartis AG (NYSE:NVS) for the development, manufacture, and commercialization of remestemcel-L, with an initial focus on treating ARDS, including that associated with COVID-19.

* The company will hold a webcast at 9 A.M ET today.

* Price Action: MESO shares are up 5.1% at $7.59 in the premarket on the last check Friday.