Omeros Announces OMS721 Presentation at 54th ERA-EDTA Congress
June 01 2017 - 7:00AM
Business Wire
Omeros Corporation (NASDAQ: OMER) today announced that data from
the company’s Phase 2 clinical trial of OMS721 for the treatment of
Immunoglobulin A (IgA) nephropathy and other kidney diseases will
be presented at the 54th European Renal Association-European
Dialysis and Transplant Association (ERA-EDTA) Congress in Madrid,
Spain. The poster “The Effect of OMS721 on Proteinuria in Patients
with IgA Nephropathy,” scheduled for presentation on Sunday, June
4, 2017, describes data from the trial’s IgA nephropathy cohort.
Geoffrey Block, M.D., Director of Clinical Research at Denver
Nephrology and Principal Investigator of the Phase 2 trial, will
discuss the data. The presentation further describes data
demonstrating statistically and clinically significant improvement
in proteinuria after 12 weeks of treatment with OMS721 in IgA
nephropathy patients. OMS721 is Omeros’ lead human monoclonal
antibody targeting mannan-binding lectin-associated serine
protease-2 (MASP-2), the effector enzyme of the lectin pathway of
the complement system.
The ERA-EDTA includes over 7000 physician members
internationally and its objective is the advancement of medical
science and clinical work in nephrology, dialysis, renal
transplantation, hypertension and other related topics. The 54th
Congress of ERA-EDTA runs from June 3 through June 6 in Madrid.
About Omeros’ MASP Programs
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. OMS721 is Omeros’ lead human MASP-2 antibody. Following
discussions with both the FDA and the European Medicines Agency, a
Phase 3 program for OMS721 in atypical hemolytic uremic syndrome
(aHUS) 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 lupus nephritis; the other has reported positive data both
in patients with hematopoietic stem cell transplant-associated
thrombotic microangiopathy (TMA) and in those with aHUS. 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. The FDA has granted
OMS721 both orphan drug status for the prevention (inhibition) of
complement-mediated TMAs and fast track designation for the
treatment of patients with aHUS.
Omeros also has identified MASP-3 as the critical activator of
the human complement system’s alternative pathway, 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 May 10,
2017. 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/20170601005639/en/
Cook Williams Communications, Inc.Jennifer Cook Williams,
360-668-3701Investor and Media Relationsjennifer@cwcomm.org
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