Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
announced top-line results from the landmark DREAM-HF Phase 3
randomized controlled trial of its allogeneic cell therapy
rexlemestrocel-L (REVASCOR®) in 537 patients with advanced chronic
heart failure1.
Over a mean 30 months of follow-up, patients with
advanced chronic heart failure who received a single endomyocardial
treatment with rexlemestrocel-L on top of maximal therapies had 60%
reduction in incidence of heart attacks or strokes and 60%
reduction in death from cardiac causes when treated at an earlier
stage in the progressive disease process. Despite significant
reduction in the pre-specified endpoint of cardiac death, there was
no reduction in recurrent non-fatal decompensated heart failure
events, which was the trial’s primary endpoint. This suggests that
rexlemestrocel-L reduces mortality by mechanisms that are distinct
from those of existing drugs that reduce hospitalization rates but
do not significantly impact cardiac mortality.
“There is an urgent need for new therapies that
can reduce the high death rates in heart failure patients by
different modes of action from existing drugs which reduce
hospitalization rates but have not significantly reduced mortality
rates,” said Mesoblast Chief Executive Dr Silviu Itescu. “The
reduction in mortality seen with rexlemestrocel-L in advanced
chronic heart failure underlines the power of this technology and
the commitment of Mesoblast to address diseases in patients with
high unmet need which are refractory to existing therapies.”
Key highlights were that a single injection of
rexlemestrocel-L, on top of maximal therapy, resulted in the
following pre-specified outcomes over a 30-month mean follow-up
period:
- Significant reduction in the incidence of non-fatal ischemic
major adverse cardiac events (MACE) due to a heart attack
(myocardial infarction, MI) or stroke (cerebrovascular accident,
CVA) by 60% relative to controls in the total population of 537
patients (p=0.002); reduction in MACE was seen consistently across
both New York Heart Association (NYHA) class II or III populations
and irrespective of whether the underlying cause of heart failure
was ischemic or non-ischemic
- Significant reduction in death from all cardiac causes (CV
death) in the 206 heart failure patients with NYHA class II disease
by 60% relative to controls (p=0.037), which was evident in both
ischemic and non-ischemic subgroups
- Prevention of NYHA class II patients progressing to CV death
rates of NYHA class III patients (p=0.004); in contrast, NYHA class
II patients on maximal therapy in the control group progressed to
CV death rates of NYHA class III patients after a mean period of 20
months of disease stability
- Significant reduction in the composite of the pre-specified CV
death or ischemic MACE outcomes in heart failure patients with NYHA
class II disease by 55% relative to controls (p=0.009)
“The trial results show that rexlemestrocel-L
significantly reduces cardiovascular mortality when used early in
heart failure patients at risk of disease progression, and provides
durable protection from heart attacks or strokes in these
vulnerable patients,” said the trial’s co-principal investigator Dr
Emerson Perin, Director of the Center for Clinical Research,
Medical Director of Texas Heart Institute, and Clinical Professor,
Baylor College of Medicine. “New therapies have not materially
reduced the high death rates from cardiovascular disease which is
why these data have the potential to change the treatment paradigm
for patients with advanced chronic heart failure.”
Mesoblast Chief Medical Officer Dr Fred Grossman
said: “We expect the mortality benefit observed in this seminal
Phase 3 trial will support a potential path for approval of
rexlemestrocel-L in patients with advanced chronic heart failure.
We are planning to meet and discuss potential pathways to approval
based on mortality reduction with the United States Food and Drug
Administration.”
Conference Call There will be a
webcast today beginning at 9.00am AEDT (Tuesday, December 15);
5.00pm EST (Monday, December 14, 2020). It can be accessed via
https://webcast.boardroom.media/mesoblast-limited/20201214/NaN5fd6e483de11ae0019f60917
The archived webcast will be available on the
Investor page of the Company’s website: www.mesoblast.com
About the DREAM HF Phase 3 Trial
Clinical outcomes were evaluated in 537 advanced heart failure
patients (206 with New York Heart Association, NYHA, class II
disease and 331 with NYHA class III disease) randomized 1:1 to
either a sham procedure or a transendocardial injection by catheter
of rexlemestrocel-L (150 million cells). Inclusion criteria
enriched the trial for patients with advanced disease by requiring
a prior heart failure hospitalization over the past nine months or
a N-terminal pro–B-type natriuretic peptide (NT-proBNP) level of at
least 1000 pg/ml. All patients were continued on maximal oral
agents for heart failure, and were followed for at least twelve
months post-procedure.
Baseline characteristics showed that both patient
groups with NYHA class II or NYHA class III clinical grades had
advanced disease, but those with NYHA class III disease had
significantly greater severity (mean NT-proBNP 2568 pg/ml for NYHA
class III vs 1842 pg/ml for NYHA class II, p=0.001).
Recurrent non-fatal heart failure MACE, incidence
of ischemic MACE due to a heart attack or stroke, and death from
cardiovascular causes (CV death), were evaluated over a mean
follow-up period of 30 months.
About Mesoblast Mesoblast 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 commercial products and 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.
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. Mesoblast has completed Phase 3 trials of
rexlemestrocel-L for advanced chronic heart failure and chronic low
back pain. 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
References 1There were 565
patients randomized of which 537 met the criteria which allowed for
treatment to occur on a 1:1 randomization basis between
rexlemestrocel-L and sham control
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
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historical fact, including our intention to discuss potential
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differ from the results anticipated in these forward-looking
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timing, progress and results of Mesoblast’s preclinical and
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into, enroll and successfully complete, clinical studies; the
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the FDA agrees to provide for an accelerated pathway to potential
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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
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information, future developments or otherwise.
Release authorized by the Chief Executive.
For more information, please contact:
Corporate Communications / Investors |
|
Schond Greenway T: +1 212 880 2060
E: schond.greenway@mesoblast.com |
Paul Hughes T: +61 3 9639 6036 E: paul.hughes@mesoblast.com |
|
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Media Kristen Bothwell T: +1 917 613 5434
E:kbothwell@rubenstein.com |
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