A major milestone is "imminent" for Australian regenerative medicine company Mesoblast (ASX: MSB) as its potential treatment for severely ill COVID-19 patients faces one of its biggest tests to date.
Following encouraging early results for its candidate product remestemcel-L in treating severe acute respiratory distress syndrome (ARDS) in patients with the virus, Melbourne-based Mesoblast's trials are advancing in the US.
The country's independent Data Safety Monitoring Board (DSMB) has set a date for early September to complete the first interim analysis of a Phase 3 trial of the medicine in ventilator-dependent COVID-19 patients with moderate to acute ARDS.
The trial's first 90 patients will have completed 30 days of follow up during August, after which the DSMB will perform an interim analysis review of the safety and efficacy data.
The DSMB will then inform Mesoblast on whether the trial should proceed as planned, or should stop early.
If the Phase 3 continues, up to 30 leading medical centers across the United States are expected to participate in the trial with recruitment due for completion in September.
The clinical protocol for evaluation has been based on results from a pilot study on patients under emergency compassionate care at Mt Sinai Hospital in New York, whereby nine of the 12 people treated were taken off a ventilator and discharged from hospital within a median of 10 days.
The current trial is randomised with placebo controls of 1:1 with two intravenous infusions of remestemcel-L to be received three to five days apart, or the placebo on top of maximal care.
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Updated at 12:03pm AEST on 30 July 2020.