Mesoblast Presents Respiratory Function Results of COVID-19 ARDS Trial at Pulmonary Disease Conference
July 15 2021 - 8:15PM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
presented clinical outcomes from the randomized controlled trial of
remestemcel-L in ventilator-dependent COVID-19 patients with
moderate/severe acute respiratory distress syndrome (ARDS). Results
of respiratory function were highlighted at the biennial Stem
Cells, Cell Therapies, and Bioengineering in Lung Biology and
Diseases conference hosted by the University of Vermont,
Burlington, VT, on July 15. The invited presentation was given by
Mesoblast Chief Executive Officer, Dr Silviu Itescu, and materials
have been lodged with the ASX.
The trial in mechanically ventilated COVID-19
patients with moderate/severe ARDS enrolled 222 patients across the
United States, of whom 217 were randomized 1:1 and received either
standard of care alone or standard of care plus 2 intravenous
infusions of remestemcel-L at a dose of 2 million cells/kg 3-5 days
apart. As previously announced, while the trial did not meet its
endpoint of 43% reduction in overall mortality, mortality was
reduced through 60 days in the pre-specified subgroup analysis of
123 patients younger than 65, but not in those older than 65 where
a more exuberant inflammatory response due to defective
immune-mediated viral clearance mechanisms may require more
prolonged or higher dosing of anti-inflammatory therapy. The
mortality benefit in patients under 65 was even greater when
remestemcel-L was used in addition to dexamethasone as standard of
care.
Key secondary outcome results that were presented
included:
- In patients under 65 years old, remestemcel-L improved
respiratory function, as defined in pre-specified analyses by
resolution or improvement in ARDS using the Berlin Criteria, at
each of days 7, 14, 21, and 30 post-randomization, with Odds Ratio
(OR) at Day 30 relative to controls of 2.2, 95% CI (1.0, 4.7)1
- In patients older than 65 years old, remestemcel-L improved
respiratory function at day 7 relative to controls, but not at
later time points, supporting the conclusion that more prolonged or
higher dosing may be warranted in those over age 65 with COVID-19
ARDS
- Remestemcel-L improved respiratory function to an even greater
extent in patients under 65 who received dexamethasone as part of
their standard of care at each of days 7, 14, 21, and 30
post-randomization, with OR at Day 30 relative to controls on
Dexamethasone alone of 3.6, 95% CI (1.2, 10.7)1
- Remestemcel-L also improved clinical outcomes based on a
7-point ordinal scale in patients under 65 who received
dexamethasone as part of their standard of care at each of days 7,
14, 21, and 30 post-randomization, with OR at Day 30 relative to
controls on Dexamethasone alone of 2.9, 95% CI (1.1, 7.7)1
Mesoblast entered into a license and collaboration
agreement with Novartis for the development, manufacture, and
commercialization of remestemcel-L, with an initial focus on the
treatment of acute respiratory distress syndrome (ARDS), including
that associated with COVID-19. The agreement remains subject to
certain closing conditions, including time to analyze the results
from this COVID-19 ARDS trial.
About Mesoblast Mesoblast is a
world leader in developing allogeneic (off-the-shelf) cellular
medicines for the treatment of severe and life-threatening
inflammatory conditions. The Company has leveraged its proprietary
mesenchymal lineage cell therapy technology platform to establish a
broad portfolio of late-stage product candidates which respond to
severe inflammation by releasing anti-inflammatory factors that
counter and modulate multiple effector arms of the immune system,
resulting in significant reduction of the damaging inflammatory
process.
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.
Mesoblast has completed Phase 3 trials of
rexlemestrocel-L for advanced chronic heart failure and chronic low
back pain. Remestemcel-L is being developed for inflammatory
diseases in children and adults including steroid refractory acute
graft versus host disease and moderate to severe acute respiratory
distress syndrome. Two products have been commercialized in Japan
and Europe by Mesoblast’s licensees, and the Company has
established commercial partnerships in Europe and China for certain
Phase 3 assets.
Mesoblast has locations in Australia, the United
States and Singapore and is listed on the Australian Securities
Exchange (MSB) and on the Nasdaq (MESO). For more information,
please see www.mesoblast.com, LinkedIn: Mesoblast Limited and
Twitter: @Mesoblast
Footnotes 1. Treatment
groups were compared using a mixed effect logistic regression model
with patient as a random effect using all available data.
Intermittent missing data assumed to be missing at random
Forward-Looking Statements This
announcement includes forward-looking statements that relate to
future events or our future financial performance and involve known
and unknown risks, uncertainties and other factors that may cause
our actual results, levels of activity, performance or achievements
to differ materially from any future results, levels of activity,
performance or achievements expressed or implied by these
forward-looking statements. All statements other than statements of
historical fact, including our intention to discuss potential next
steps with the FDA, are forward-looking statements, which are often
indicated by terms such as “anticipate,” “believe,” “could,”
“estimate,” “expect,” “goal,” “intend,” “likely,” “look forward
to,” “may,” “plan,” “potential,” “predict,” “project,” “should,”
“will,” “would” and similar expressions and variations thereof. We
make such forward-looking statements pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995
and other federal securities laws. Forward-looking statements
should not be read as a guarantee of future performance or results,
and actual results may differ from the results anticipated in these
forward-looking statements, and the differences may be material and
adverse. The risks, uncertainties and other factors that may impact
our forward-looking statements include, but are not limited to: the
timing, progress and results of Mesoblast’s preclinical and
clinical studies; Mesoblast’s ability to advance product candidates
into, enroll and successfully complete, clinical studies; the
timing or likelihood of regulatory filings and approvals; whether
the FDA agrees to a path forward; and the pricing and reimbursement
of Mesoblast’s product candidates, if approved; Mesoblast’s ability
to establish and maintain intellectual property on its product
candidates and Mesoblast’s ability to successfully defend these in
cases of alleged infringement. You should read this press release
together with our risk factors, in our most recently filed reports
with the SEC or on our website. Uncertainties and risks that may
cause Mesoblast’s actual results, performance or achievements to be
materially different from those which may be expressed or implied
by such statements, and accordingly, you should not place undue
reliance on these forward-looking statements. Unless required by
law, we do not undertake any obligations to publicly update or
revise any forward-looking statements, whether as a result of new
information, future developments or otherwise.
Release authorized by the Chief Executive.
For more information, please contact:
Corporate Communications / Investors |
Media |
Paul
Hughes |
Sumit
Media |
T: +61 3
9639 6036 |
Grant
Titmus |
E:
investors@mesoblast.com |
T: +61 419
388 161 |
|
E:
grant@sumitmedia.com.au |
|
|
|
Kristen
Bothwell |
|
T: +1 917
613 5434 |
|
E:
kbothwell@rubenstein.com |
Mesoblast (NASDAQ:MESO)
Historical Stock Chart
From Jun 2024 to Jul 2024
Mesoblast (NASDAQ:MESO)
Historical Stock Chart
From Jul 2023 to Jul 2024