COVID-19 ARDS and ARDS Share Price Scenarios, page-233

Data to be presented this week (see below) formed part of the clinical justification in support of Mesoblast’s submission to the United States Food and Drug Administration (FDA) for an Investigational New Drug (IND) application evaluating remestemcel-L in the treatment of patients with COVID-19 ARDS. Review of the cost/benefit analysis resulted in the FDA clearing Mesoblast to proceed with the expanded access compassionate use program and a Phase 3 randomized controlled trial in patients with moderate to severe ARDS from COVID 19.

Results using Mesoblast's allogeneic mesenchymal stem cell product candidate remestemcel-L in patients with inflammatory lung disease have been selected for oral presentation at
the 2020 International Society of Cell and Gene Therapy (ISCT) annual meeting being held May 28-29, 2020. The virtual presentation is entitled ‘Mesenchymal Stem Cell Therapy Improves Pulmonary Function and Exercise Tolerance in Patients with Chronic Obstructive Pulmonary Disease (COPD) and High Baseline Inflammation’.

The post-hoc analysis from a randomized, placebo-controlled 60-patient Phase 2 trial in patients with COPD showed that remestemcel-L 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 also observed in patients with various acute lung diseases, including acute respiratory distress syndrome (ARDS), a life-threatening complication of COVID-19.

Cell-based therapies are costly treatments. Clinical and commercial success for Mesoblast is in cell-based therapies for life-threatening (acute) diseases ie: moderate to severe COVID ARDS cases with high mortality rate. Therefore, development strategies should focus on allogeneic off-the-shelf products. Studies have shown that the majority of administered MSCs (>80%) accumulate immediately in the lungs.

In the current COVID environment and potential suite of therapies, Mesoblast's product remestemcel-L could play a vital role as an emergency life-threatening therapy in dire circumstances. Early risk/benefit analysis indicates an overwhelming requirement to stockpile this cell therapy in the interests of the people.

Patience....