This has been an unprecedented year due to the coronavirus pandemic, its impact on human health, and the economic consequences it has wrought. The Mesoblast leadership responded with great agility and resilience to this urgent challenge, creatively applying our technology platform to develop a potential treatment for moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19.
Through a deep understanding of the science, and utilizing the clinical and regulatory teachings gained from years of meticulous development, our team has harnessed the anti- inflammatory and reparative properties of our mesenchymal lineage cell technology.
The original indication for which our lead allogeneic cell therapy remestemcel-L was developed, pediatric steroid-refractory acute graft versus host disease (SR-aGVHD), has a shared mechanism of action with COVID-19 ARDS. Accordingly,
we have now pivoted remestemcel-L to also target ARDS, the principal cause of death in COVID-19 infection.
Remestemcel-L is being rigorously evaluated in a randomized controlled trial to confirm earlier pilot data showing the therapy's effectiveness to enable gravely ill COVID-19 patients to be taken off ventilators in the shortest timeframe possible.
The results, if positive, of this ongoing 300-patient Phase 3 trial in COVID-19 ARDS patients 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. If a survival benefit is confirmed, Mesoblast plans to seek potential approval of this therapy in the highest risk patients. In parallel, we will continue to pursue an accelerated approval pathway for remestemcel-L in the treatment of children with SR-aGVHD, a life-threatening condition with
no approved therapies for those under 12 years of age.
Beyond remestemcel-L, we believe we have developed the most mature and diverse portfolio of cellular medicines for serious acute and chronic inflammatory conditions, and readouts of Phase 3 trials in these additional programs will underpin both our near-term value proposition and our medium to long-term strategic initiatives.
The Board would especially like to highlight the outstanding external and internal leadership displayed by our Chief Executive Dr Silviu Itescu, and the unwavering diligence and work ethic displayed by the entire Mesoblast team during these very difficult times.
We are deeply grateful for the ongoing support of our investors whose continued confidence has provided us with the capital to successfully prosecute our business strategy.
Joseph R. Swedish