BOSTON, Sept. 23, 2020 /PRNewswire/ -- Stealth
BioTherapeutics (Nasdaq: MITO), a clinical-stage biotechnology
company focused on the discovery, development and commercialization
of novel therapies for diseases involving mitochondrial
dysfunction, today announced that the company will present an
abstract in a poster session at the upcoming 2020 Annual Northeast
Amyotrophic Lateral Sclerosis (NEALS) Meeting, which is being held
online from September 30th
to October 1st. The
selected poster has been awarded the 2020 Annual NEALS Meeting
UMN/PLS Poster Award.
The poster, entitled "The mitochondrial targeted peptidomimetic
SBT-272 protects cortical spinal motor neurons from mutant TDP43
pathology," demonstrates that SBT-272 protects upper motor neurons
from mutant TDP43 driven neurodegeneration. TDP43 pathology has
been observed in multiple neurodegenerative diseases, including
Amyotrophic Lateral Sclerosis (ALS), Frontotemporal Lobar
Degeneration (FTLD), Lewy Body Dementia (LBD), Progressive
Supranuclear Palsy (PSP), and Alzheimer's Disease, and is believed
to play a role in neuronal cell death. The data from this study
supports further investigation of SBT-272 for the treatment of
these and other neurodegenerative diseases in which TDP43 pathology
is thought to contribute to disease burden.
About SBT-272
SBT-272 is a novel peptidomimetic being developed for the
treatment of neurodegenerative diseases involving mitochondrial
dysfunction. SBT-272 has been shown to increase adenosine
triphosphate (ATP) production and decrease levels of reactive
oxygen species (ROS) in dysfunctional mitochondria in preclinical
studies. SBT-272 demonstrates higher mitochondrial uptake and
greater concentrations in the central nervous system relative to
elamipretide, Stealth's first-in-class lead compound.
Treatment with SBT-272 was associated with a dose-dependent delay
in the onset of neurological disease, a reduction in systemic
markers of neurodegeneration and prolonged lifespan in a mouse
model of amyotrophic lateral sclerosis (ALS). In addition, SBT-272
treatment was associated with the preservation of dopaminergic
neurons in the substantia nigra of a mouse model of mutant
alpha-synuclein driven neurodegeneration. Alpha-synucleinopathy is
a common pathological feature of several neurodegenerative
diseases, including Parkinson's Disease, Multiple Systems Atrophy
and Alzheimer's Disease. Further preclinical evaluation
of SBT-272 in the context of protein misfolding diseases which
lead to mitochondrial dysfunction and subsequent neurodegeneration
is on-going.
About Stealth
We are a clinical-stage biotechnology company focused on the
discovery, development and commercialization of novel therapies for
diseases involving mitochondrial dysfunction. Mitochondria, found
in nearly every cell in the body, are the body's main source of
energy production and are critical for normal organ function.
Dysfunctional mitochondria characterize a number of rare genetic
diseases and are involved in many common age-related diseases,
typically involving organ systems with high energy demands such as
the heart, the eye, and the brain. We believe our lead product
candidate, elamipretide, has the potential to treat both rare
metabolic cardiomyopathies, such as Barth, Duchenne and Becker
muscular dystrophies and Friedreich's ataxia, rare mitochondrial
diseases entailing nuclear DNA mutations, such as POLG-related
disorders, as well as ophthalmic diseases entailing mitochondrial
dysfunction, such as dry age-related macular degeneration and
Leber's hereditary optic neuropathy. We are evaluating our
second-generation clinical stage candidate, SBT-272, for rare
neurodegenerative disease indications following promising
preclinical data in amyotrophic lateral sclerosis, or ALS. We have
optimized our discovery platform to identify novel
mitochondria-targeted compounds, including SBT-259, the SBT-550
series of compounds, and other compounds which may be nominated as
therapeutic product candidates or utilized as scaffolds to deliver
other compounds to mitochondria.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Such forward-looking statements include those
regarding Stealth BioTherapeutics' plans, strategies and
expectations for its preclinical and clinical advancement of its
drug development programs, including its ongoing clinical trials of
elamipretide and SBT-272; its plans for the potential submission of
an NDA; the potential benefits of Stealth
BioTherapeutics' product candidates; its key milestones for
2020 and 2021; its plans regarding future data presentations; and
its financial guidance regarding the period in which it will have
capital available to fund its operations. Statements that are
not historical facts, including statements about Stealth
BioTherapeutics' beliefs, plans and expectations, are
forward-looking statements. The words "anticipate," "expect,"
"hope," "plan," "potential," "possible," "will," "believe,"
"estimate," "intend," "may," "predict," "project," "would" and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Stealth BioTherapeutics may
not actually achieve the plans, intentions or expectations
disclosed in these forward-looking statements, and you should not
place undue reliance on these forward-looking statements.
Actual results or events could differ materially from the
plans, intentions and expectations disclosed in the forward-looking
statements as a result of known and unknown risks, uncertainties
and other important factors, including: Stealth
BioTherapeutics' ability to obtain additional funding and to
continue as a going concern; the impact of the COVID-19 pandemic;
the ability to successfully demonstrate the efficacy and safety
of Stealth BioTherapeutics' product candidates and future
product candidates; the preclinical and clinical results
for Stealth BioTherapeutics' product candidates, which
may not support further development and marketing approval; the
potential advantages of Stealth BioTherapeutics' product
candidates; the content and timing of decisions made by
the U.S. FDA, the EMA or other regulatory authorities,
investigational review boards at clinical trial sites and
publication review bodies, which may affect the initiation, timing
and progress of preclinical studies and clinical trials
of Stealth BioTherapeutics product
candidates; Stealth BioTherapeutics' ability to obtain
and maintain requisite regulatory approvals and to enroll patients
in its planned clinical trials; unplanned cash requirements and
expenditures; competitive factors; Stealth
BioTherapeutics' ability to obtain, maintain and enforce
patent and other intellectual property protection for any product
candidates it is developing; and general economic and market
conditions. These and other risks are described in greater
detail under the caption "Risk Factors" included in
the Stealth BioTherapeutics' most recent Annual Report on
Form 20-F filed with the Securities and Exchange
Commission ("SEC"), as well as in any future filings with
the SEC. Forward-looking statements represent
management's current expectations and are inherently uncertain.
Except as required by law, Stealth BioTherapeutics does
not undertake any obligation to update forward-looking statements
made by us to reflect subsequent events or circumstances.
Investor Relations
Stern Investor Relations
Lauren Stival, 212-362-1200
IR@StealthBT.com
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SOURCE Stealth BioTherapeutics Inc.