Mesoblast Limited (MESO) has announced that it has received ethics approval to include Australian hospitals in the Phase 3 randomized controlled trial of remestemcel-L in ventilator-dependent COVID-19 patients with acute respiratory distress syndrome (ARDS).
Participating hospitals in Melbourne and Sydney have been granted approval by the Human Research Ethics Committee of Monash Health and will join more than 17 leading US medical centers already in the Phase 3 trial.
This study is being conducted by the US National Institutes of Health–funded Cardiothoracic Surgical Trials Network, and cleared by the US Food and Drug Administration (FDA).
Principal Investigator Tony Goldschlager said: “We are pleased that Monash Health is involved in this important COVID-19 trial, especially given the extensive experience we have had with Mesoblast’s mesenchymal lineage cells.”
The clinical protocol evaluating remestemcel-L in up to 300 patients in the Phase 3 trial was based on results from a pilot study using remestemcel-L under emergency compassionate care at Mt Sinai Hospital in New York, with 75% (nine of 12) of patients with moderate to severe ARDS successfully taken off a ventilator and discharged from hospital within a median of 10 days.
The Phase 3 trial is enrolling ventilator-dependent patients in intensive care units with moderate to severe COVID-19 ARDS randomized (1:1) to receive either two intravenous infusions of remestemcel-L three to five days apart or placebo on top of maximal care. The primary endpoint is all-cause mortality within 30 days of randomization, with the key secondary endpoint being the number of days off mechanical ventilator support.
The trial’s independent Data Safety Monitoring Board (DSMB) plans to complete an interim analysis this month in the trial’s first 90 patients randomized in the US after they have completed 30 days of follow up.
After review of the safety and efficacy data, the DSMB will provide a recommendation to Mesoblast on whether the trial should proceed as planned, or stop early.
Mesoblast’s lead product candidate, remestemcel-L, is an investigational therapy comprising culture expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is believed to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions. (See MESO stock analysis on TipRanks).
Shares in MESO have spiked 157% year-to-date, and the stock scores a unanimous buy rating from the Street- adding up to a Strong Buy consensus. The average analyst price target stands at $22 indicating 14% upside potential lies ahead.
Analysts reiterated their bullish calls after Mesoblast announced that the US Advisory Committee voted 9-1 in favor of remestemcel-L (Ryoncil) efficacy in pediatric steroid refractory graft vs. host disease.
“Considering the positive safety profile of Ryoncil compared to other therapies and the unmet need in the indication, we continue to see a high likelihood of approval” cheered Maxim analyst Jason McCarthy. According to the analyst, remestemcel is very much still on track and the PDUFA is next: 9/30.
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