SEATTLE, Nov. 6, 2014 /PRNewswire/ -- Omeros Corporation
(NASDAQ: OMER) today announced positive data using a derivative of
OMS721 in a well-established animal model of stroke. OMS721 is the
company's lead human monoclonal antibody targeting mannan-binding
lectin-associated serine protease-2 (MASP-2). MASP-2 is critical to
the function of the lectin pathway, one of the principal components
of the complement system, a key part of the immune response. Omeros
controls the worldwide rights to MASP-2 inhibition and to all
therapeutics targeting MASP-2.
The study evaluated the effect of MASP-2 blockade on
neurological deficits and the size of brain infarcts 48 hours after
induction of an ischemic stroke. Compared to control
antibody-treated mice, mice treated with MASP-2 antibody
demonstrated significantly reduced neurological deficits 48 hours
after an ischemic stroke. In addition, the infarcted area of the
brain was significantly smaller in MASP-2 antibody-treated mice. A
similar degree of protection was also observed in gene-targeted
MASP-2-deficient mice, which showed significantly lesser
neurological deficits and infarct sizes compared to wild-type
control mice.
The study was conducted by the team of Dr. Maria-Grazia de Simoni, director of the
Laboratory of Inflammation and Nervous System Diseases at the Mario
Negri Research Institute in Milan,
in collaboration with Dr. Wilhelm
Schwaeble, professor of immunology at the University of
Leicester and Royal Society-Wolfson Research Merit Award Holder.
"The data from this study clearly identify the lectin pathway as a
central contributor to the damage and disability resulting from the
ischemic injury of stroke," stated Dr. de Simoni. "Our findings are
consistent with human clinical data supporting the importance of
the lectin pathway in stroke and underscore the attractiveness of
MASP-2 as a potential target for the treatment of stroke
patients."
Every year, more than 800,000 people in the U.S. suffer a
stroke, almost 90 percent of which are ischemic, and approximately
one out of six are fatal. A leading cause of serious long-term
disability, the cost of stroke in the U.S. is estimated at
$37 billion annually
[http://www.cdc.gov/stroke/facts.htm].
"These results are exciting and expand our understanding of the
lectin pathway's central role in ischemia-reperfusion injury across
multiple organs, including the brain, heart and kidney," said
Gregory A. Demopulos, chairman and
chief executive officer of Omeros Corporation. "The importance of
the lectin pathway and of MASP-2, the pathway's critical effector
enzyme, in the pathogenesis of a wide range of diseases and
disorders continues to grow within the complement research
community, and Omeros plans to explore a wide range of clinical
indications for OMS721 and our MASP programs."
OMS721 is currently being evaluated in a Phase 2 clinical trial
in patients with complement-mediated thrombotic microangiopathies
(TMAs), including atypical hemolytic uremic syndrome (aHUS),
thrombotic thrombocytopenic purpura (TTP), and stem cell
transplant-related TMAs. Thrombotic microangiopathies are a family
of rare, debilitating and life-threatening disorders characterized
by multiple thrombi (clots) in the microcirculation of the body's
organs, most commonly the kidney and brain. Omeros expects to be
able to release data later this month on the effect of OMS721 on
thrombus formation in a human ex vivo pathophysiologic
system of aHUS using serum from aHUS patients both in the acute
phase and in remission.
About Omeros' MASP-2 Program
Omeros controls the
worldwide rights to MASP-2 and all therapeutics targeting MASP-2, a
novel pro-inflammatory protein target involved in activation of the
complement system, which is an important component of the immune
system. The complement system plays a role in the inflammatory
response and becomes activated as a result of tissue damage or
microbial infection. MASP-2 appears to be unique to, and required
for the function of, one of the principal complement activation
pathways, known as the lectin pathway. Importantly, inhibition of
MASP-2 does not appear to interfere with the antibody-dependent
classical complement activation pathway, which is a critical
component of the acquired immune response to infection, and its
abnormal function is associated with a wide range of autoimmune
disorders. MASP-2 is generated by the liver and is then released
into the circulation. Adult humans who are genetically deficient in
one of the proteins that activate MASP-2 do not appear to be
detrimentally affected by the deficiency. Therefore, Omeros
believes that it may be possible to deliver MASP-2 antibodies
systemically and OMS721, its lead MASP-2 antibody, is designed to
be self-administered by subcutaneous injection.
Omeros also believes that it has identified the proteins that
activate the complement system's alternative pathway in humans,
which is linked to a wide range of immune-related disorders. In
addition to its lectin pathway inhibitors, the Company is advancing
the development of antibodies that would block activation of the
alternative pathway alone or in combination with the lectin
pathway.
About Omeros Corporation
Omeros is a
biopharmaceutical company committed to discovering, developing and
commercializing small-molecule and protein therapeutics for
large-market as well as orphan indications targeting inflammation,
coagulopathies and disorders of the central nervous system. Derived
from its proprietary PharmacoSurgery® platform, the
Company's first drug product, Omidria™ (phenylephrine
and ketorolac injection) 1%/0.3%, has been approved by the FDA for
use during cataract surgery or intraocular lens replacement (ILR)
to maintain pupil size by preventing intraoperative miosis (pupil
constriction) and to reduce postoperative ocular pain. Omeros is
completing preparations for a planned U.S. product launch no later
than early 2015. Omidria is currently under review for marketing
approval by the European Medicines Agency. Omeros also has six
clinical-stage development programs focused on complement-related
thrombotic microangiopathies, Huntington's disease, schizophrenia,
and cognitive impairment; on addictive and compulsive disorders;
and on preventing problems associated with surgical procedures.
Omeros also has a proprietary GPCR platform, which is making
available an unprecedented number of new GPCR drug targets and
corresponding compounds to the pharmaceutical industry for drug
development.
Forward-Looking Statements
This press release
contains forward-looking statements within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934, which are subject to the "safe harbor"
created by those sections for such statements. All statements other
than statements of historical fact are forward-looking statements,
which are often indicated by terms such as "anticipate," "believe,"
"could," "estimate," "expect," "goal," "intend," "look forward to,"
"may," "plan," "potential," "predict," "project," "should," "will,"
"would" and similar expressions. Forward-looking statements are
based on management's beliefs and assumptions and on information
available to management only as of the date of this press release.
Omeros' actual results could differ materially from those
anticipated in these forward-looking statements for many reasons,
including, without limitation, risks associated with effectiveness
of Omidria™ sales and marketing efforts, Omidria market
acceptance, product pricing and reimbursement, Omeros' ability to
obtain regulatory approval for its Marketing Authorization
Application in the EU for the commercialization of Omidria, Omeros'
unproven preclinical and clinical development activities,
regulatory oversight, product commercialization, intellectual
property claims, competitive developments, litigation, and the
risks, uncertainties and other factors described under the heading
"Risk Factors" in the Company's Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on August 11, 2014. Given these risks, uncertainties
and other factors, you should not place undue reliance on these
forward-looking statements, and the company assumes no obligation
to update these forward-looking statements, even if new information
becomes available in the future.
SOURCE Omeros Corporation