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  • Medtech developer Mesoblast (MSB) has been approved to trial its novel remestemcel-L treatment for COVID-19-related acute respiratory distress syndrome (ARDS) in the U.S.
  • ARDS occurs due to an excessive immune response against the COVID-19 virus in the lungs
  • Remestemcel-L is believed to counteract this inflammatory process by both minimising inflammation and promoting the body’s anti-inflammatory response
  • Remestemcel-L has already been evaluated in over 1,100 patients with various other inflammatory conditions
  • Mesoblast shares have risen over 35 per cent in the last week. At the start of Thursday’s session, they’re worth $2.02 each

Medtech developer Mesoblast (MSB) has been approved to trial its novel remestemcel-L treatment for COVID-19 related acute respiratory distress syndrome (ARDS) in the U.S.

The study

Mesoblast holds an Investigational New Drug (IND) Application from the United States Food and Drug Administration (FDA) for use of remestemcel-L in the treatment of patients with COVID-19 ARDS.

Now, a public-private partnership in collaboration with the Cardiothoracic Surgical Trials Network (CTSN) will formally evaluate remestemcel-L in a randomised, placebo-controlled trial in 240 patients with ARDS caused by coronavirus infection.

ARDS occurs due to an excessive immune response against the COVID-19 virus in the lungs. Patients experience what is known as a ‘cytokine storm’ when inflammatory cytokines produced by the body’s immune cells start destroying lung tissue.

Remestemcel-L is believed to counteract this inflammatory process by minimising the production of inflammatory cytokines, promoting the production of anti-inflammatory cytokines, and enabling the function of naturally occurring anti-inflammatory cells in the affected tissue.

Remestemcel-L has already been trialled successfully for various other inflammatory conditions, including one phase three trial in children with steroid-refractory acute graft versus host disease (aGVHD), a potentially fatal inflammatory condition which produces a similar cytokine storm process as that seen in COVID-19 ARDS.

The therapy also proved effective in a randomised, placebo-controlled study in 60 patients with chronic obstructive pulmonary disease, showing remestemcel-L significantly improved respiratory function in patients with the same elevated inflammatory biomarkers that are observed in patients with COVID-19 ARDS.

Together, these compelling outcomes indicate the great potential for using remestemcel-L in patients with COVID-19 ARDS.

Mesoblast Chief Medical Officer Dr Fred Grossman says remestemcel-L is an ideal test candidate in the treatment of COVID-19 ARDS.

“The mortality rate in moderate to severe ARDS due to COVID-19 can be as high as 80 per cent,” Dr Fred explained.

“Remestemcel-L has demonstrated safety, efficacy and significant survival benefit in aGVHD where inflammation is at the core, similar to ARDS from COVID-19.”

Mesoblast Chief Medical Officer Dr Fred Grossman

“The mechanism of action of remestemcel-L demonstrated in aGVHD supports the evaluation of remestemcel-L to safely tame a similar cytokine storm in the lungs that leads to the high mortality in patients with COVID-19,” he added.

What’s next?

Mesoblast’s trial will be deployed over the coming weeks. As cases begin to spike in the U.S. — and worldwide — the alleviation of the symptoms related to ARDS is key to saving the lives of vulnerable people. If novel treatments like remestemcel-L prove effective against such symptoms, they may reduce the mortality rates associated with COVID-19 related ARDS.

CTSN Chairman Dr Marc Gillinov says he hopes the treatment can save lives.

“We are excited to work with Mesoblast to make a real impact on the high mortality associated with COVID-19. This randomized controlled trial is in line with our mandate to rigorously evaluate novel therapies for public health imperatives,” Dr Marc explained.

Professor and System Chair of Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai, Dr Annetine Gelijns, says a novel anti-inflammatory for ARDS has great potential to lighten the load on the health system.

“The COVID-19 pandemic has resulted in very large numbers of people suffering with ARDS requiring ventilation in hospital intensive care units, with dismal outcomes, placing an enormous burden on the United States health system,” Dr Annetine expressed.

“We are committed to evaluating whether Mesoblast’s mesenchymal stem cell product candidate for ARDS has the potential to make an impact on this unprecedented health crisis,” she stated.

The safety and therapeutic effects of remestemcel-L intravenous infusions have already been evaluated in over 1,100 patients in various clinical trials.

If it does indeed prove effective against the symptoms of ARDS in COVID-19 patients, the therapy has the potential to save thousands of lives worldwide.

Mesoblast shares have risen over 35 per cent in the last week. At the start of Thursday’s session they’re worth $1.83.5 each.

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