Omeros Announces OMS721 Presentation at Annual Meeting of the European Society for Blood and Marrow Transplantation
March 28 2017 - 7:00AM
Business Wire
-- Additional Positive
“Challenge-Rechallenge” Data Reported in Patient with Stem Cell
Transplant-Associated TMA --
Omeros Corporation (NASDAQ: OMER) today announced presentation
of a case report describing resolution of hematopoietic stem cell
transplant-associated thrombotic microangiopathy (HSCT-TMA) in a
dialysis- and transfusion-dependent adolescent girl who was treated
with OMS721 under a compassionate-use protocol. The presentation
“Resolution of acute kidney injury secondary to TA-TMA by the
anti-MASP-2 monoclonal antibody OMS721 in a pediatric HSCT
recipient” occurred at the 43rd Annual Meeting of the European
Society for Blood and Marrow Transplantation in Marseille,
France on Monday, March 27, 2017. Marco Zecca, M.D., Director of
Pediatric Oncology at the Fondazione IRCCS Policlinico San Matteo,
presented the data. 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 presentation describes a girl who developed HSCT-TMA
following stem cell transplantation at 14 years of age. She was
initially treated with eculizumab but did not tolerate treatment,
developing pulmonary edema that recurred on retreatment with
eculizumab. The HSCT-TMA became life-threatening and she required
hemodialysis and daily platelet transfusions. Dr. Zecca, the
patient’s physician, requested OMS721 for compassionate-use
treatment and Omeros complied. Following OMS721 treatment, the
patient was able to discontinue hemodialysis and to decrease
substantially her platelet transfusion requirements. Recently, the
patient’s dose of OMS721 was tapered, but she developed a viral
infection that reactivated her HSCT-TMA. Her TMA was again
successfully treated with restoration of the original OMS721 dose.
To date, she has remained free of both dialysis and
transfusions.
“This patient had severe TMA that I believe would have caused
her death,” stated Dr. Zecca. “Her positive response to OMS721
treatment, both initially and following her virus-induced relapse
during tapering, was impressive – the results of OMS721 treatment
in this challenge-rechallenge scenario underscore the important
effects of the drug. Since the poster was produced, her TMA has
remained in remission and we have been able to discontinue her
platelet transfusions. Her rapid response has been heartening, and
we all are grateful for this remarkable outcome.”
Thrombotic microangiopathy is a potentially life-threatening
complication of HSCT. Approximately 20,000 HSCT procedures are
performed in the U.S. annually, and TMA is reported to occur in up
to 30 percent of HSCT patients. Although the kidney is the most
commonly affected organ, HSCT-TMA is a multi-system disorder and
can also manifest clinically in the lungs, gastrointestinal tract
and central nervous system. Reported mortality in patients with
multi-organ involvement is greater than 90%. Even in patients who
survive acute episodes, HSCT-TMA increases the risk for chronic
kidney disease and end-stage renal disease.
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;
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 Annual Report on Form 10-K
filed with the Securities and Exchange Commission on March 16,
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/20170328005644/en/
Cook Williams Communications, Inc.Jennifer Cook WilliamsInvestor
and Media Relations360.668.3701jennifer@cwcomm.org
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