Mesoblast Update on COVID-19 ARDS Trial
December 17 2020 - 6:31PM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today provided an update
on the randomized controlled trial of remestemcel-L in
ventilator-dependent patients with moderate to severe acute
respiratory distress syndrome (ARDS) due to COVID-19 infection
after the Data Safety Monitoring Board (DSMB) performed a third
interim analysis on the trial’s first 180 patients. The trial was
powered to achieve a primary endpoint of 43% reduction in mortality
at 30 days for treatment with remestemcel-L on top of maximal care
in a trial of 300 patients. This projected mortality reduction was
based on pilot data observed during the initial stages of the
pandemic when control mortality rates were exceedingly high and
prior to new evolving treatment regimens that have reduced disease
mortality in ventilated patients. The DSMB reported that there were
no safety concerns and noted that the trial is not likely to meet
the 30-day mortality reduction endpoint at the planned 300 patient
enrolment. The DSMB recommended that the trial complete with the
currently enrolled 223 patients, and that all be followed-up as
planned.
Notably, the trial has not yet accrued data on the secondary
endpoints, which include days alive off mechanical ventilation at
60 days post randomization, overall survival, days in intensive
care, duration of hospitalization, and cardiac, neurological, and
pulmonary organ damage. Additionally, measures of circulating
cytokines and inflammatory markers will be evaluated. None of these
were included in the interim analysis. As such, the trial will
evaluate all 223 enrolled patients through 60 days of follow-up to
study potential treatment effects on these outcomes. Mesoblast and
Novartis will both analyse these results to identify meaningful
clinical outcomes that may guide decisions on the development
program for remestemcel-L in non-COVID ARDS.
During the course of the trial, as the pandemic has evolved,
numerous changes in the treatment regimens for COVID-19 patients
occurred, including both prior to and while on mechanical
ventilation that may have an effect on the mortality endpoint in
the trial. These include extended management of patients prior to
ventilator support, and use of experimental therapies such as
dexamethasone, anti-virals, and re-purposed immunomodulatory
agents. All of these may have changed the natural course of
ventilated patients and reduced overall mortality rates during the
trial compared to the early stages of the pandemic.
Mesoblast entered into a license and collaboration agreement
with Novartis on November 20, 2020 for the development, manufacture
and commercialization of remestemcel-L, with an initial focus on
the treatment of ARDS, including that associated with COVID-19, and
other indications. The closing of the agreement is subject to the
expiration or termination of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act and certain other
conditions.
About Remestemcel-L Remestemcel-L is an
investigational therapy comprising culture-expanded mesenchymal
stromal cells derived from the bone marrow of an unrelated donor.
Remestemcel-L is thought to have immunomodulatory properties to
counteract the cytokine storms that are implicated in various
inflammatory conditions by downregulating the production of
pro-inflammatory cytokines, increasing production of
anti-inflammatory cytokines, and enabling recruitment of naturally
occurring anti-inflammatory cells to involved tissues.
About Mesoblast Mesoblast Limited (ASX:MSB;
Nasdaq:MESO) is a world leader in developing allogeneic
(off-the-shelf) cellular medicines. The Company has leveraged its
proprietary mesenchymal lineage cell therapy technology platform to
establish a broad portfolio of late-stage product candidates.
Mesoblast has a strong and extensive global intellectual property
portfolio with protection extending through to at least 2040 in all
major markets. The Company’s proprietary manufacturing processes
yield industrial-scale, cryopreserved, off-the-shelf, cellular
medicines. These cell therapies, with defined pharmaceutical
release criteria, are planned to be readily available to patients
worldwide. For more information, please see www.mesoblast.com,
LinkedIn: Mesoblast Limited and Twitter: @Mesoblast
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Release authorized by the Chief Executive.
Corporate Communications / InvestorsSchond
GreenwayT: +1 212 880
2060E: schond.greenway@mesoblast.com |
Paul HughesT: +61 3 9639 6036E: paul.hughes@mesoblast.com |
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MediaKristen
BothwellT: +1 917 613 5434E: kbothwell@rubenstein.com |
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