Australian cell therapy company Mesoblast (ASX:MSB) has announced the US FDA has cleared one of its investigational therapies for trials in acute respiratory distress syndrome caused by COVID-19.
The company has a background in the development of cell therapies for the treatment of inflammatory diseases.
The FDA-cleared trial will see the company direct its investigational intravenous allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L to the symptomatic treatment of COVID-19.
According to Mesoblast chief medical officer, Dr Fred Grossman, “The FDA clearance provides a pathway in the United States for use of remestemcel-L in patients with COVID-19 ARDS, where the prognosis is very dismal, under both expanded access compassionate use and in a planned randomized controlled trial.”
Remestemcel-L, which is being developed for various inflammatory conditions, is believed to counteract inflammatory processes by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells .
The safety and therapeutic effects of remestemcel-L intravenous infusions have already been evaluated in clinical trials involving around 1,100 patients.
The company said one previous trial involving remestemcel-L for patients with chronic obstructive pulmonary disease showed it improved respiratory function in patients "with the same elevated inflammatory biomarkers that are also observed in patients with COVID-19 ARDS."