-- Presentation Will Highlight Efficacy and Safety Results --
SEATTLE--(BUSINESS WIRE)--Dec. 7, 2016--
Omeros Corporation (NASDAQ: OMER) today announced that an abstract
highlighting positive results from the ongoing OMS721 Phase 2 clinical
trial in patients with hematopoietic stem cell transplant-associated
thrombotic microangiopathy (HSCT-TMA) has been accepted for presentation
at the 2017 Tandem Meeting of the American Society of Blood and Marrow
Transplantation and the Center for International Blood and Marrow
Transplant Research in Orlando, Florida. OMS721 is Omeros’ lead human
monoclonal antibody targeting mannan-binding lectin-associated serine
protease-2 (MASP-2). In addition to its Phase 2 clinical program in
TMAs, OMS721 is currently in a Phase 3 program for patients suffering
from atypical hemolytic uremic syndrome and in a Phase 2 program for
renal diseases, including immunoglobulin A (IgA) nephropathy and
membranous nephropathy.
The title of the abstract is “Early Results of Phase II Study Using
OMS721 in Patients with Hematopoietic Stem Cell Transplant-Associated
Thrombotic Microangiopathy (HCT-TMA),” and will be presented on
Saturday, February 25, by Dr. Samer Khaled, M.D., Assistant Clinical
Professor of Hematology and Hematopoietic Cell Transplantation at City
of Hope in Duarte California and OMS721 clinical investigator.
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 the other 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/20161207005536/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org
