Mesoblast set to launch drug to treat lethal COVID-19 complications by the end of the year

Australian group Mesoblast is getting closer to a release date for a groundbreaking drug to treat potentially lethal COVID-19 complications.

Mesoblast CEO Silviu Itescu. Picture: Stuart McEvoy.

Stem cell-focused biotech Mesoblast says it is on track to release its drug to treat patients with potentially lethal COVID-19 complications by the end of the year.

The announcement came as the group announced its revenue for the 2020 full year had almost doubled.

Chief executive Silviu Itescu said the company was working with the US Food and Drug Administration, which is set to decide on approving its drug remestemcel-L next month.

Already the FDA’s advisory committee has voted in favour of the drug’s efficacy 9:1. The vote was on remestemcel-L’s application for treating children with steriod-refractory acute graft versus host disease (aGVHD), which has a similar immune response seen in patients with severe complications from coronavirus.

Mesoblast is currently completing phase three trials in the US to test the efficacy of remestemcel-L on COVID-19 patients suffering the potentially lethal acute respiratory distress syndrome.

About 300 patients are enrolled in the trial and early next month Mesoblast is expected to reveal their initial results. If the results strongly support its hypothesis, it will then seek to have it approved as a treatment for COVID-19 as well a graft-versus-host disease.

Dr Itescu expected to launch the drug in the US in the fourth quarter of this year.

It comes as Mesoblast’s revenue soared 92 per cent to $US32.2m ($44.51m) in the year to June 30. This included a 127 per cent surge in milestone revenue – payments that are made at different stages of drug development – from strategic partnerships to $US25m.

Meanwhile, the company cut its annual loss 13 per cent to $US77.9m versus $US89.8m in 2019.

“We are very pleased to report the significant corporate progress made by the company over the last financial year. The most notable achievement was the successful FDA Advisory Committee meeting held this month which resulted in an overwhelmingly positive vote in favour of the efficacy of our lead product candidate remestemcel-L,” Dr Itescu said.

“We are working closely with the FDA ahead of next month’s approval action date and are well prepared for a potential US launch during Q4 2020, with inventory build and a commercial organisation in place.

“In parallel, based on its anti-inflammatory effects in aGVHD, we have positioned remestemcel-L to address the most significant inflammatory complications in children and adults infected with COVID-19. Our randomised controlled Phase 3 trial continues to enrol adults in the US with acute respiratory distress syndrome, aiming to reduce the primary cause of mortality due to COVID-19 infection.”

Dr Itescu said Mesoblast had also made remestemcel-L available to doctors for treatment of COVID-19 infected children with multisystem inflammatory syndrome (MIS-C) involving the heart under the company’s Expanded Access Program.

“We look forward to the upcoming results of our COVID-19 studies and the Phase 3 trials for chronic advanced heart failure and discogenic low back pain.”