-- Shows Substantial Advantage over C5 Inhibitor --
SEATTLE--(BUSINESS WIRE)--Aug. 10, 2016--
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). In a
well-established animal model associated with paroxysmal nocturnal
hemoglobinuria (PNH), OMS906 significantly improved the survival of red
blood cells when compared to control-treated animals and to animals
treated with a complement component 5 (C5) inhibitor.
Paroxysmal nocturnal hemoglobinuria is a rare, acquired,
life-threatening disease of the blood. The hallmarks of PNH are
defective red blood cells that result in their premature destruction by
the complement system (part of a person’s own immune system), repeated
blood clots and bone marrow dysfunction. The only drug approved by the
U.S. Food and Drug Administration and corresponding international
regulatory agencies for the treatment of PNH is eculizumab, a C5
inhibitor. Paroxysmal nocturnal hemoglobinuria is driven by the
alternative pathway of complement (APC), and MASP-3 is essential for the
activation of the APC.
OMS906, a MASP-3 inhibitor, has been demonstrated to block the
activation of the APC. In a well-established animal model associated
with PNH, OMS906 protected PNH-like red blood cells (RBCs) significantly
better than did C5 inhibition. In the group treated with a potent C5
inhibitor, 80-percent destruction of PNH-like RBCs occurred at less than
one day but was delayed until approximately 8 days in the OMS906-treated
group (p = 0.008). In addition, overall in vivo survival of
PNH-like RBCs, determined by area-under-the-curve analysis, was
approximately 4-fold greater in the OMS906-treated group than that
treated with the C5 inhibitor (p = 0.029).
“These data further demonstrate that MASP-3 inhibition, and specifically
OMS906, blocks activation of the complement system’s alternative
pathway,” said Sir Peter Lachmann, ScD FRCP FRCPath FRS FMedSci,
Emeritus Sheila Joan Smith Professor of Immunology, University of
Cambridge. “Paroxysmal nocturnal hemoglobinuria is one of many diseases
and disorders involving the alternative pathway, and this study showed
that OMS906 provided a profound improvement over C5 inhibition in
survival of red blood cells. This is likely due to the ability of OMS906
and other MASP-3 inhibitors to block not only intravascular hemolysis,
as do C5 inhibitors, but also to prevent extravascular hemolysis, a
problem that C5 inhibition cannot address. Based on these data, I would
expect a MASP-3 inhibitor to have important advantages relative to a C5
inhibitor in the treatment of patients with PNH.”
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
inhibiting mannan-binding lectin-associated serine protease-3 (MASP-3),
a protein essential for the activation 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, 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. 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 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 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, Omeros’ 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 August 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/20160810005412/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org