Ann: Remestemcel-L Improves Outcomes in Inflammatory Lung Disease, page-5

REMESTEMCEL-L IMPROVES RESPIRATORY AND FUNCTIONAL OUTCOMES IN PATIENTS WITH INFLAMMATORY LUNG DISEASEPhase 2 Trial Results Presented At 2020 International Society for Cell & Gene Therapy Annual MeetingMelbourne, Australia; June 1, 2020 and New York, USA; May 31, 2020: Mesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that treatment with its lead mesenchymal stem cell (MSC) product candidate remestemcel-L in patients with chronic obstructive pulmonary disease (COPD) and an elevated state of inflammation resulted in improved respiratory and functional outcomes. The results were presented as a virtual oral presentation delivered to the 2020 International Society for Cell & Gene Therapy (ISCT) annual meeting held May 28-29, 2020.The post-hoc analysis from a randomized, placebo-controlled 60-patient Phase 2 trial in patients with COPD showed that remestemcel-L, given in four monthly intravenous doses of 100 million cells, significantly improved respiratory and functional clinical outcomes in patients with elevated levels of the inflammatory biomarker C-reactive protein (CRP). Significantly elevated CRP levels are predictive of increased hospitalization and death in patients with COPD1, and are seen in various acute lung diseases, including acute respiratory distress syndrome (ARDS), a life-threatening complication of COVID-19. These results support potential of remestemcel-L to effectively treat inflammatory lung diseases, such as acutely decompensated COPD and ARDS.Key findings were:The greater the degree of inflammation, as measured by elevated CRP levels, the greater the signal of efficacy of remestemcel-L treatment in improving moderate to severe lung diseaseSignificant improvements were observed in each of the pre-specified endpoints tested, forced expiratory volume, forced vital capacity, and the distance walked in the six-minute walk test (all p <0.01), with maximal effects on all parameters seen at four monthsIn patients with the highest level of CRP (>4mg/L), those who received remestemcel-L were able to walk 55 meters further than placebo-treated patients in the six-minute walk test at four months (p=0.004); the six-minute walk test is a major independent predictor of mortality in COPD2The dose administered was well tolerated with no infusion-related toxicity and no identified safety concerns.Mesoblast Chief Medical Officer Dr Fred Grossman said: “The correlation between highest CRP levels and greatest degree of response to remestemcel-L suggests that the inflammatory component of the lung disease may trigger and be amenable to the immunomodulatory effects of treatment with remestemcel-L in patients with acute inflammatory conditions. Since recurrent hospitalization rates and mortality in COPD are associated with both high levels of CRP and progressive decline in the six- minute walk test, these results suggest that remestemcel-L could provide longer-term benefits for COPD patients with high levels of inflammation. They also provide a compelling rationale for the evaluation of remestemcel-L in the current United States Phase 3 randomized controlled trial of 300 patients with moderate to severe COVID-19 ARDS.”