BOSTON, Feb. 23, 2021 /PRNewswire/ -- Stealth
BioTherapeutics Corp (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 completed enrollment
for ReCLAIM-2 (SPIAM-202), and expects top-line data in the first
half of 2022. ReCLAIM-2 is a phase 2 randomized,
double-masked, placebo-controlled study to evaluate the efficacy
and pharmacokinetics of elamipretide in patients with dry
age-related macular degeneration (AMD) with geographic atrophy
(GA).
"Distorted vision, reduction in low luminance visual acuity,
reduced visual acuity, and blurred vision are symptoms of dry AMD
with geographic atrophy and have a negative impact on the quality
of life of affected patients," said Dr. Jeff Heier, director
of the retina service and retina research at Ophthalmic Consultants
of Boston and Lead Investigator.
"Data demonstrated in prior trials suggests elamipretide may be
able to help our patients with dry AMD, and I was pleased to be
able to offer our patients the opportunity to participate in this
trial."
"We believe that mitochondria-targeted therapeutics offer a
differentiated approach to treat diseases of aging, such as dry
AMD, which significantly affects the independence of over a million
elderly patients," said Reenie
McCarthy, Stealth's CEO. "By targeting the
bioenergetic deficits that drive pathology in this disease, we hope
to improve visual function for affected patients. Completing
enrollment of this trial represents a meaningful milestone in our
mission to improve the health-span of patients suffering from
diseases of aging and also fulfills the condition for additional
funding ($10m) under the Development
Funding Agreement announced in October
2020."
The ReCLAIM-2 study completed enrollment with 176 patients. The
primary endpoint of the 48-week study will measure the
low-luminance best-corrected visual acuity, which assesses visual
function under low light conditions meant to represent dusk or
indoor (artificial) lighting. Secondary functional endpoints are
change in low-luminance reading acuity, best-corrected visual
acuity (BCVA). Secondary imaging endpoints assessing the rate
of progression of the disease include GA area as measured by fundus
autofluorescence and optical coherence tomography.
In November 2018, the U.S. Food and Drug
Administration granted Fast Track designation for elamipretide
for patients with dry AMD with GA.
For additional information on the ReCLAIM-2 study or
elamipretide, please refer to Stealth's website and
ClinicalTrials.gov.
About Age-Related Macular Degeneration
AMD, a progressive eye condition that is the leading cause of
blindness in adults, is estimated to affect approximately 10
million people in the U.S. AMD affects the center portion
of the retina, called the macula, which is responsible for central
vision and color perception. Although there are FDA-approved
treatments for wet AMD, which affects approximately 10 percent of
those suffering from the disease, there are no approved therapies
for dry AMD. Dry AMD with GA, an advanced form of dry AMD, is
characterized by central blind spots leading to permanent loss of
vision. The disease is a major contributor to loss of
independence and diminished quality of life in older persons.
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 muscular
dystrophy 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 AMD and Leber's hereditary optic neuropathy. We are
evaluating our second-generation clinical-stage candidate, SBT-272,
and our new series of small molecules, SBT-550, for rare
neurological disease indications following promising preclinical
data. We have optimized our discovery platform to identify novel
mitochondria-targeted 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
planned clinical trial of SBT-272; the potential benefits of
Stealth BioTherapeutics' product candidates; its key milestones for
2021; its plans regarding future data presentations; its
interactions with regulatory authorities; 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; 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
Janhavi Mohite, 212-362-1200
IR@StealthBT.com
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SOURCE Stealth BioTherapeutics Inc.