-- NEURON-Funded Program Will Evaluate
Benefits of Omeros’ MASP-2 Antibody --
Omeros Corporation (NASDAQ: OMER) today announced that an
international consortium of complement experts from Italy, United
Kingdom, Germany, Spain and Poland was awarded €1.3 million in
grant funding to study the benefits of inhibiting mannan-binding
lectin-associated serine protease-2 (MASP-2) and the lectin pathway
in traumatic brain injury (TBI). Omeros’ OMS721 is a human
monoclonal antibody that inhibits MASP-2, which is the effector
enzyme of the lectin pathway of the complement system. Omeros
controls the worldwide rights to MASP-2 and all therapeutics
targeting MASP-2.
The international consortium was awarded the grant by the
Network of European Funding for Neuroscience Research
(ERANET-NEURON), which is part of a European research area network
funded by the European Commission. The consortium’s project is
entitled, “New therapeutic strategies in the treatment of traumatic
brain injury by targeting the LEctin
Activation Pathway of complement,” or LEAP, and is focused on
defining the contribution of lectin pathway activators and enzymes
(MASP-1, MASP-2, and MASP-3) in driving post-traumatic brain injury
and on assessing the therapeutic utility of MASP-2-blocking
antibodies to reduce TBI-related morbidity and mortality in
patients. The program also targets the development of biomarkers
for use in TBI clinical trials.
Traumatic brain injury is a leading cause of death and of
permanent disability worldwide, contributing to about 30% of all
injury deaths in the U.S. Those who survive a TBI can face effects
(e.g., cognitive, movement, vision or hearing, and emotional)
lasting a few days to disabilities which may last the rest of their
lives. In 2010, about 2.5 million emergency department visits,
hospitalizations, or deaths in the U.S. were associated with
TBI. Within minutes following the trauma, TBI induces the
activation of several injurious cascades that develop over time and
account for the majority of brain damage. Among these, the lectin
pathway of complement and its effector enzyme MASP-2 have been
identified to contribute substantially to the detrimental outcome
of TBI.
“We are pleased that ERANET-NEURON has chosen to fund our
consortium to evaluate further the role of the lectin pathway and
MASP-2 in traumatic brain injury,” stated Dr. Maria-Grazia De
Simoni, Head of the Laboratory of Inflammation and Nervous System
Diseases, IRCCS-Istituto di Ricerche Farmacologiche Mario Negri and
coordinator of the study. “We believe that the lectin pathway plays
a critical role in brain injury as evidenced by our published data
showing that Omeros’ MASP-2 inhibitor OMS721 significantly reduced
brain infarct size and protected against neurologic functional loss
in a well-established animal model of stroke. We look forward to
sharing the results of our collaborative efforts to develop
therapeutic strategies for the treatment of traumatic brain
injury.”
Omeros currently has an ongoing Phase 3 clinical program
evaluating OMS721 in atypical hemolytic uremic syndrome as well as
Phase 2 programs assessing the drug in hematopoietic stem cell
transplant-associated thrombotic microangiopathy and in IgA
nephropathy, membranous nephropathy, C3 glomerulopathy and lupus
nephritis.
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 is the
effector enzyme of the lectin pathway, one of the principal
complement activation pathways. 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 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. Omeros has received both Orphan Drug status and Fast
Track designation from the U.S. FDA for its lead human MASP-2
antibody OMS721. Following discussions with both the FDA and the
European Medicines Agency, a Phase 3 program for OMS721 in atypical
hemolytic uremic syndrome is in progress. Also, two Phase 2 trials
are ongoing. One is evaluating OMS721 in glomerulonephropathies,
which has generated positive data in patients with immunoglobulin A
(IgA) nephropathy and with membranous nephropathy and, in a patient
with C3 glomerulopathy, findings from kidney biopsies demonstrate
substantial improvement following treatment with OMS721. The other
Phase 2 trial is being conducted in patients with thrombotic
microangiopathies (TMAs), with positive data reported in patients
with hematopoietic stem cell transplant-associated TMA. In addition
to potential intravenous administration, Omeros plans to
commercialize OMS721 for one or more therapeutic indications as a
subcutaneous injection and is also developing small-molecule
inhibitors of MASP-2. Based on requests from treating physicians,
Omeros has established a compassionate-use program for OMS721,
which is active in both the U.S. and Europe.
Omeros also has identified MASP-3 as the protein that is
critical to the activation of 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 its development of antibodies
and small-molecule inhibitors against MASP-3 to block activation of
the alternative pathway.
About Omeros Corporation
Omeros is a biopharmaceutical company committed to discovering,
developing and commercializing both small-molecule and protein
therapeutics for large-market as well as orphan indications
targeting inflammation, coagulopathies and disorders of the central
nervous system. Part of its proprietary PharmacoSurgery® platform,
the company’s first drug product, OMIDRIA® (phenylephrine and
ketorolac injection) 1% / 0.3%, was broadly launched in the U.S. in
April 2015. OMIDRIA is the first and only FDA-approved drug (1) for
use during cataract surgery or intraocular lens (IOL) replacement
to maintain pupil size by preventing intraoperative miosis (pupil
constriction) and to reduce postoperative ocular pain and (2) that
contains an NSAID for intraocular use. In the European Union, the
European Commission has approved OMIDRIA for use in cataract
surgery and lens replacement procedures to maintain mydriasis
(pupil dilation), prevent miosis (pupil constriction), and to
reduce postoperative eye pain. Omeros has clinical-stage
development programs focused on: complement-associated thrombotic
microangiopathies; complement-mediated glomerulonephropathies;
Huntington’s disease and cognitive impairment; and addictive and
compulsive disorders. In addition, Omeros has a proprietary G
protein-coupled receptor (GPCR) platform, which is making available
an unprecedented number of new GPCR drug targets and corresponding
compounds to the pharmaceutical industry for drug development, and
a platform used to generate antibodies.
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 and variations thereof. 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 product
commercialization and commercial operations, unproven preclinical
and clinical development activities, regulatory oversight,
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 November
9, 2016. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161130005646/en/
Cook Williams Communications, Inc.Jennifer Cook WilliamsInvestor
and Media Relations360-668-3701jennifer@cwcomm.org
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