-- NEURON-Funded Program Will Evaluate Benefits of Omeros’ MASP-2
Antibody --
SEATTLE--(BUSINESS WIRE)--Nov. 30, 2016--
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161130005646/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360-668-3701
jennifer@cwcomm.org
