In an Oct. 13 research note, Dawson James Securities analyst Jason Kolbert reported that Mesoblast Ltd.'s (MESO:NASDAQ; MSB:ASX) Phase 3 COVID-19 acute respiratory distress syndrome (ARDS) clinical trial is 50%-plus enrolled.
Up to 300 ventilator-dependent patients with moderate to severe ARDS will be enrolled in total in up to 30 teaching hospitals throughout North America. Recruitment is expected to be completed in three to four months.
Kolbert briefly reviewed the other study design components and objectives. The randomized, double-blinded, controlled trial will evaluate Mesoblast's mesenchymal stem cell product, remestemcel-L, plus maximal care in ARDS, the main cause of death in patients with COVID-19. Study patients will receive either remestemcel-L or placebo.
The primary trial endpoint is mortality at 30 days. The secondary endpoint is the number of days alive, off of ventilator support, within 60 days. An interim analysis is planned when 30% of enrolled patients reach the first endpoint.
With the study, Mesoblast aims to confirm the results of a pilot study carried out earlier this year, in March and April, at New York's Mount Sinai Hospital, Kolbert noted. It showed that nine of 12, or 75%, of ventilator-dependent inpatients were taken off of ventilator support due to improvement and discharged a median of 10 days after receiving two intravenous doses of remestemcel-L within five days.
Should the Phase 3 data readout be positive, Kolbert indicated, the next steps for Australia-based Mesoblast are to obtain fast-tracked regulatory approval, expand manufacturing capabilities and develop manufacturing and commercialization partnerships.
Dawson James has a Buy rating and a $20 per share target price on Mesoblast, the stock of which is currently trading at about $11.81 per share.[NLINSERT]
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