Rexlemestrocel-L Shows Greatest Treatment Benefit on Major Adverse Cardiovascular Events in High-Risk Heart Failure Patients With Diabetes and/or Myocardial Ischemia
December 05 2021 - 6:47PM
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in
allogeneic cellular medicines for inflammatory diseases, today
provided new analyses from the landmark DREAM-HF Phase 3 trial
showing that the greatest treatment benefit from rexlemestrocel-L
is in HFrEF patients with diabetes and/or ischemia, who are at
high-risk of cardiovascular mortality, heart attacks or strokes.
In recent guidance to Mesoblast, FDA confirmed that reduction in
incidence of cardiovascular mortality or irreversible morbidity
(non-fatal heart attack or stroke) is a clinically meaningful
acceptable endpoint in patients with chronic HFrEF and encouraged
Mesoblast to identify the highest-risk group with greatest
likelihood of beneficial response to intervention with
rexlemestrocel-L in the DREAM-HF Phase 3 trial.
In line with this guidance, Mesoblast performed additional
analyses of MACE outcomes in pre-specified high-risk patient groups
from the landmark DREAM-HF trial, and the results were presented
December 3 by Chief Executive Dr Silviu Itescu at the 18th Global
CardioVascular Clinical Trialists Forum (CVCT) in Washington
DC.
The data showed that:
- While a single rexlemestrocel-L dose on
top of maximal standard of care therapies reduced the composite
3-point MACE in all 537 patients by 33% (p=0.02) over a mean
follow-up of 30 months, a hierarchical analysis across
pre-specified high-risk subgroups showed greatest benefit in
patients with diabetes and/or myocardial ischemia (hazard ratio
0.63, p=0.019)
- Among control patients with HFrEF
(n=276) all of whom were treated with maximal available standard of
care therapies, risk of 3-point MACE was 1.9-fold higher in
controls with diabetes and/or myocardial ischemia (n=192) than
controls with neither diabetes nor myocardial ischemia (n=84),
p=0.02. This confirmed the ongoing high-risk of 3-point MACE in
control patients with diabetes and/or myocardial ischemia due to
micro- and macro-vascular disease despite receiving optimal
standard of care therapies
- Compared to control patients,
rexlemestrocel-L reduced the incidence of 3-point MACE by 37%
overall in NYHA class II or III HFrEF patients with diabetes and/or
myocardial ischemia (n=385, p=0.02) and by 54% in those with
diabetes and/or myocardial ischemia who had evidence of systemic
inflammation, as defined by elevated baseline levels of hs-CRP
>2mg/L (n=212, p=0.003).
Diabetes Mellitus is not only a significant risk factor in the
onset of heart failure, it also increases the risk of mortality and
morbidity in patients who have existing heart failure.1-3 Type 2
diabetes causes structural heart disease and heart failure through
myocardial ischemia involving small and large vessels. Importantly,
inflammation which is a critical component of the pathophysiology
of the disease is also known to accelerate large vessel
atherosclerosis.1
The 3-point composite MACE is an endpoint the FDA has previously
accepted for approval of multiple drugs to reduce cardiovascular
risk in diabetic patients. FDA guidance states that reliance on a
single study to provide the substantial evidence of effectiveness
necessary to support a Biologic License Application (BLA) is
generally limited to situations in which a trial has demonstrated a
clinically meaningful effect on mortality, irreversible morbidity,
or prevention of a disease with potentially serious outcome for
which confirmation of the result with a second trial would be
practically or ethically impossible. Mesoblast will submit for
formal FDA review the new data analyses showing the reduction in
mortality and irreversible morbidity by rexlemestrocel-L in HFrEF
patients with diabetes and/or myocardial ischemia, to agree on a
potential pathway to approval.
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
2041 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 is developing product candidates for distinct
indications based on its remestemcel-L and rexlemestrocel-L stromal
cell technology platforms. 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. Rexlemestrocel-L is in
development 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
Footnotes
- Dunlay SM., et al. Circulation. 2019;140:e294–e324
- Wang CCL et al. Circulation 2019; 139: 1741-1743.
- McGuire DK et al. JAMA Cardiol. 2021; 6:148-158.
Forward-Looking StatementsThis 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 agree with FDA on a potential
pathway to approval, 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 regulatory pathway; 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 |
|
|
|
Rubenstein |
|
Nadine Woloshin |
|
T: +1 917-699-9456 |
|
E: nwoloshin@rubenstein.com |
Mesoblast (NASDAQ:MESO)
Historical Stock Chart
From May 2024 to Jun 2024
Mesoblast (NASDAQ:MESO)
Historical Stock Chart
From Jun 2023 to Jun 2024