--Data Presented at the Recent Combined International and American
Blood & Marrow Transplantation Meetings--
SEATTLE--(BUSINESS WIRE)--Mar. 1, 2017--
Omeros Corporation (NASDAQ: OMER) today announced additional positive
data from the ongoing Phase 2 clinical trial evaluating OMS721 in the
treatment of hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HCT-TMA). These data were presented at the combined
annual meetings of the Center for International Blood & Marrow
Transplant Research (CIBMTR) and the American Society for Blood and
Marrow Transplantation (ASBMT). The presentation, “Early Results of a
Phase 2 Study Using OMS721 in Patients with Hematopoietic Stem Cell
Transplant-Associated Thrombotic Microangiopathy (HCT-TMA),” summarized
clinical data from the seven HCT-TMA patients who to date have been
treated with OMS721. Samer Khaled, M.D., Assistant Clinical Professor of
Hematology & Hematopoietic Cell Transplantation at City of Hope,
presented the data Saturday, February 25, 2017.
The Phase 2 uncontrolled clinical trial is ongoing in patients with one
of three types of TMA, including HCT-TMA. To be eligible for enrollment,
HCT-TMA patients are required to be adults with post-transplant TMA
persisting at least two weeks following calcineurin inhibitor
modification (conservative treatment). This population is at high risk
for poor outcomes, including mortality. The primary efficacy endpoint of
the study is change in platelet count. Additional efficacy endpoints
include changes in lactate dehydrogenase (LDH) and haptoglobin levels.
The presentation included multiple figures summarizing these efficacy
measures following treatment with OMS721. Consistent with previously
reported results, statistically significant and clinically meaningful
improvements in TMA disease activity were observed over the course of
treatment, specifically in mean platelet count, mean LDH and mean
haptoglobin. Mean creatinine also improved but did not reach statistical
significance.
“TMA following stem cell transplantation can be a devastating
complication, especially in these patients who had failed conservative
treatment,” stated Dr. Khaled. “Their respective prognoses were poor,
and the positive responses that we have observed with OMS721 are truly
impressive. We are continuing to enroll patients in this study and I
look forward to working with Omeros to move OMS721 through further
development.”
Thrombotic microangiopathy is a potentially life-threatening
complication of HCT. Approximately 20,000 HCT procedures are performed
in the U.S. annually, and TMA is reported to occur in approximately 10
to 25 percent of HCT patients. Although the kidney is the most commonly
affected organ, HCT-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, HCT-TMA
increases the risk for chronic kidney disease and end-stage renal
disease.
The most common adverse events observed to date in the study have been
diarrhea, abdominal pain, anemia, neutropenia, hyperbilirubinemia,
hyperkalemia and graft-versus-host disease, all of which commonly occur
with HCT. A total of ten serious adverse events have been reported, none
considered related to OMS721 treatment. Two patients died of progression
of cancer after less than three weeks of OMS721 treatment and one
patient died of graft failure after completing the study and positively
responding to OMS721. None of these deaths was considered by the
investigators to be related to OMS721 treatment.
“We are excited about the consistently positive results in this study,”
stated Gregory A. Demopulos M.D., chairman and chief executive officer
of Omeros. “HCT-TMA is frequently fatal and there is no approved
treatment. We plan to discuss our data with the FDA and international
regulatory agencies as we continue to design an efficient Phase 3
program with the objective of accelerating access to OMS721 for
physicians and their patients.”
Additional data related to treatment of HCT-TMA with OMS721 will be
presented at the Annual Meeting of the European Society of Blood and
Marrow Transplantation in Marseille, France later next month.
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/20170301005694/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org
