The US FDA has granted fast-track designation to Mesoblast's (ASX:MSB) remestemcel-L in the treatment of acute respiratory distress syndrome (ARDS) due to COVID-19 infection.
The designation is granted if a therapy demonstrates the potential to address unmet medical needs for a serious or life-threatening disease.
ARDS is the primary cause of death in patients with COVID-19. Under the fast-track designation, a Biologic License Application (BLA) for remestemcel-L is eligible for both rolling submission and priority review.
Mesoblast said it provided clinical data provided to the FDA supporting the potential of remestemcel-L to address the unmet medical need of COVID-19 ARDS. The data included results from a pilot study under emergency compassionate use at New York’s Mt Sinai Hospital in March and April this year.
In this study, nine of 12 ventilator-dependent patients (75 per cent) with moderate to severe COVID-19 ARDS were successfully discharged from hospital a median of 10 days after receiving two intravenous doses of remestemcel-L.
The ongoing randomised controlled phase three trial of remestemcel-L in up to 300 ventilator-dependent patients with moderate to severe COVID-19 ARDS, under an FDA Investigational New Drug clearance, is approximately two-thirds enrolled.
The trial’s primary endpoint is overall mortality at day 30 and the key secondary endpoint is days alive off ventilatory support through day 60.
Mesoblast recently entered into a license and collaboration agreement with Novartis for the development, manufacture and commercialization of remestemcel-L, with an initial focus on the treatment of ARDS, including COVID-19 ARDS.