Mesoblast Limited (ASX: MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, has received ethics approval to include Australian hospitals in the Phase 3 randomised controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with acute respiratory distress syndrome (ARDS).
Chief Executive Dr Silviu Itescu, said participating hospitals in Melbourne and Sydney have been granted approval by the Human Research Ethics Committee of Monash Health and will join more than 17 leading US medical centres already in the Phase 3 trial.
This study is being conducted by the US National Institutes of Health–funded Cardiothoracic Surgical Trials Network, and cleared by the US Food and Drug Administration (FDA).
As an Australian company developing a potential treatment for COVID-19 ARDS, the primary cause of death in patients infected with COVID-19, we have a responsibility to evaluate remestemcel-L in Australian patients as the country continues to grapple with COVID-19,” Dr Itescu said.
The clinical protocol evaluating remestemcel-L in up to 300 patients in the Phase 3 trial was based on results from a pilot study using remestemcel-L under emergency compassionate care at Mt Sinai Hospital in New York, with 75% (nine of 12) of patients with moderate to severe ARDS successfully taken off a ventilator and discharged from hospital within a median of 10 days.
The Phase 3 trial is enrolling ventilator-dependent patients in intensive care units with moderate to severe COVID-19 ARDS randomized (1:1) to receive either two intravenous infusions of remestemcel-L three to five days apart or placebo on top of maximal care.
The primary endpoint is all-cause mortality within 30 days of randomization, with the key secondary endpoint being the number of days off mechanical ventilator support.
The trial’s independent Data Safety Monitoring Board (DSMB) plans to complete an interim analysis this month in the trial’s first 90 patients randomized in the US after they have completed 30 days of follow up. After review of the safety and efficacy data, the DSMB will provide a recommendation to Mesoblast on whether the trial should proceed as planned, or stop early.
Mesoblast’s lead product candidate, remestemcel-L, is an investigational therapy comprising culture- expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor.
Remestemcel-L is believed to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by down-regulating the production of pro- inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.