Mesoblast’s remestemcel-L receives FDA IND clearance for treating COVID-19 patients with acute respiratory distress
US FDA IND approval paves the way for Mesoblast’s remestemcel-L to be used on COVID-19 patients with acute respiratory distress syndrome.
Regenerative medicine company Mesoblast (ASX: MSB) has received US Food and Drug Administration Investigational New Drug (IND) clearance for its remestemcel-L treatment to be used in COVID-19 patients presenting with acute respiratory distress syndrome.
According to Mesoblast chief medical officer Dr Fred Grossman, the FDA IND approval now enables US-based COVID-19 patients with poor prognosis to be treated with remestemcel-L under compassionate usage grounds and in a planned randomised controlled trial.
Remestemcel-L is an anti-inflammatory treatment that has been developed for use in various inflammatory conditions including steroid-refractory acute graft versus host disease.
Mesoblast claims the drug works by counteracting the inflammatory processes in these diseases by down-regulating the production of pro-inflammatory cytokines, while boosting production of anti-inflammatory cytokines and enabling recruitment of the ant-inflammatory cells to the involved tissues.
To-date, the safety and therapeutic impact of remestemcel-L intravenous infusions have been evaluated in over 1,100 patients in clinical trials.
In a phase 3 trial, remestemcel-L was found useful in treating acute graft versus host disease, which Mesoblast claims produces a similar cytokine storm process as seen in COVID-19 patients with acute respiratory distress syndrome.
Additionally, post hoc analysis of a previous study involving 60 patients with chronic obstructive pulmonary demonstrated remestemcel-L “significantly improved” respiratory function in patients with the same elevated inflammatory biomarkers that are also seen in COVID-19 acute respiratory distress syndrome patients.
Acute respiratory distress syndrome
COVID-19 patients most at risk of developing acute respiratory distress syndrome include the elderly and those with co-morbidities such as diabetes.
According to Mesoblast, patients with COVID-19 that have developed acute respiratory distress syndrome have an almost 50% fatality rate.
Remestemcel-L is an allogeneic mesenchymal stem cell product, with preliminary data from China indicating allogeneic mesenchymal stem cells have either cured or “significantly improved” functional outcomes for seven patients with COVID-19 in the small trial.
By mid-morning trade, Mesoblast’s shares were up almost 30% to $1.74.