Data from Omeros’ OMS721 Phase 2 Clinical Trial in Patients with Stem Cell Transplant-Associated TMA to be Presented at Int...
December 07 2016 - 7:00AM
Business Wire
-- Presentation Will Highlight Efficacy and
Safety Results --
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.
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version on businesswire.com: http://www.businesswire.com/news/home/20161207005536/en/
Cook Williams Communications, Inc.Jennifer Cook WilliamsInvestor
and Media Relations360.668.3701jennifer@cwcomm.org
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