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Omeros' Lead MASP-3 Inhibitor OMS906 Demonstrates Blockade of the Alternative Pathway of Complement System
Omeros Corporation (NASDAQ: OMER) today announced results from its
OMS906 complement program. OMS906 is Omeros' lead antibody targeting
mannan-binding lectin-associated serine protease-3 (MASP-3), the protein
activator of the alternative pathway of complement (APC (News - Alert)). OMS906
significantly reduced both incidence and severity of disease in a
well-established animal model of arthritis mediated by the APC.
In the animal model, induced by administration of auto-antibodies
against mouse connective tissue, OMS906 reduced the incidence and
severity of disease as measured by clinical arthritis scores in a
dose-dependent fashion. Compared to control-treated animals, OMS906
reduced the incidence by 86 percent (p-value < 0.005) and severity of
the disease by 90 percent (p-value < 0.01) at the highest dose tested. A
single dose of OMS906 administered intravenously to mice led to
near-complete ablation of systemic APC activity for at least 14 days.
"The robust data clearly show that MASP-3 inhibition, and OMS906
specifically, blocks activation of the alternative pathway," said B.
Paul Morgan, BSc, MB BCh, PhD, FRCPath, MRCP, FMedSci, Professor of
Immunology and Director of Systems Immunity Research Institute, Cardiff
University. "OMS906, in addition to its demonstrated effects in
arthritis, has therapeutic potential for the treatment of a broad range
of diseases mediated by the alternative pathway, ranging from traumatic
brain injury to paroxysmal nocturnal hemoglobinuria. The unique
mechanism of action of MASP-3 inhibitors - shutting down the conversion
of pro-factor D to factor D - may have clinical advantages over other
alternative pathway inhibitors."
MASP-3 circulates in the body at a relatively low concentration and slow
catabolic rate, allowing for sustained inhibition of the
pro-inflammatory pathway through intravenous, subcutaneous and oral
routes of administration. Omeros exclusively controls the use of MASP-3
inhibitors for the treatment of APC-related diseases and disorders. The
company is initiating the process of manufacturing scale-up of OMS906 in
preparation for clinical trials.
About Omeros' MASP-3 Inhibitor Program
The complement system
plays a key role in inflammation and becomes activated as a result of
tissue damage or microbial infection. Omeros' MASP-3 inhibitor program
includes potent molecules selectively inhibitingmannan-binding
lectin-associated serine protease-3 (MASP-3), the protein activator of
the alternative pathway of complement (APC). APC inhibitors are thought
to have preventive or therapeutic effects across a broad range of
diseases including hemolytic uremic syndrome (HUS), atypical HUS,
paroxysmal nocturnal hemoglobinuria, traumatic brain injury, arthritis,
wet age-related macular degeneration, ischemia-reperfusion injury,
transplant-related complications and other immune-related disorders.
Omeros is developing both antibody and small molecules to block MASP-3.
Through its growing intellectual property position, Omeros exclusively
controls inhibitors of the protein activator of the alternative pathway
(MASP-3) and, with its OMS721 program, inhibitors of the effector enzyme
of the lectin pathway (MASP-2), allowing the company to target with
unprecedented precision diseases caused by dysregulation of one or both
of these pathways.
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. Derived from 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 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. 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 five clinical-stage development programs focused on:
complement-related thrombotic microangiopathies; complement-mediated
glomerulopathies; Huntington's disease and cognitive impairment;
addictive and compulsive disorders; and preventing problems associated
with urologic surgical procedures. 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 including with respect to
OMIDRIA®, Omeros' ability to partner and commercialize
OMIDRIA in the Middle East and Europe, Omeros' unproven preclinical and
clinical development activities, regulatory oversight, intellectual
property claims, competitive developments, litigation including pending
patent litigation related to an application seeking approval from the
FDA to market a generic version of OMIDRIA, 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 May 10, 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/20160804005483/en/
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