SEATTLE--(BUSINESS WIRE)--Jun. 1, 2017--
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170601005639/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams,
360-668-3701
Investor and Media Relations
jennifer@cwcomm.org
