Randomized Controlled Phase 3 Trial of Remestemcel-L for Reduced Mortality in COVID-19 Acute Respiratory Distress Syndrome Surpasses 50% Enrollment
NEW YORK, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that the randomized controlled Phase 3 trial of remestemcel-L on top of maximal care in ventilator-dependent patients with acute respiratory distress syndrome (ARDS) due to COVID-19 infection has surpassed 50% enrollment. The trial’s primary endpoint is reduction in 30-day mortality relative to maximal care. ARDS continues to be the primary cause of death in COVID-19 patients.
Mesoblast Chief Medical Officer Dr Fred Grossman said: “There is an urgent need for targeted treatments to reduce the continued high mortality in COVID-19 ARDS patients who are dependent on mechanical ventilators. We expect to complete the enrollment target in this important trial by the end of the year as the enrollment rate continues to increase in line with the surge in new infections across the United States.”
The randomized, double-blinded, controlled trial is enrolling up to 300 ventilator-dependent patients with moderate to severe ARDS, and aims to confirm findings from a pilot study at New York’s Mt Sinai Hospital in March-April this year. In that study, nine of 12 ventilator-dependent patients (75%) were successfully discharged from hospital a median of 10 days after receiving two intravenous doses of remestemcel-L within five days. The United States Food and Drug Administration (FDA) cleared the Phase 3 trial to commence enrollment following a review of the trial design and clinical endpoints.
Remestemcel-L is being developed for the treatment of severe diseases associated with excessive cytokine storm, including COVID-19 ARDS and acute graft versus host disease. The ability to reduce production of damaging pro-inflammatory cytokines, which are central to tissue damage in both ARDS and acute GVHD, provides a unifying mechanism of action for remestemcel-L in the treatment of these diseases. The results from the randomized controlled Phase 3 trial in COVID-19 ARDS patients, if positive, will build upon the totality of the evidence for the effectiveness of remestemcel-L in adults and children with severe and life-threatening inflammatory conditions.
The trial’s independent Data Safety Monitoring Board (DSMB) recently completed an interim analysis of safety and efficacy including primary endpoint of all-cause mortality within 30 days of randomization of the trial’s first 90 enrolled patients and recommended that the trial continue as planned. The DSMB will perform a second interim analysis in early November when 45% of the enrollment target has completed 30 days of follow-up.
Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid-refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.
Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
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