-- Targeted Indications for the Company’s
MASP-2 Inhibitor Continue to Expand --
Omeros Corporation (NASDAQ: OMER) today announced positive
results in patients with hematopoietic stem cell
transplant-associated thrombotic microangiopathy (HSCT-TMA) from
the company's Phase 2 clinical trial of OMS721 in TMAs, with
clinically meaningful improvement in measures of red blood cell
destruction, specifically lactate dehydrogenase (LDH) and
haptoglobin levels (p < 0.01 and p < 0.06, respectively).
Severe HSCT-TMAs carry a high mortality rate. 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 (or Berger’s
disease) and membranous nephropathy.
All HSCT-TMA patients in the Phase 2 open-label clinical trial
are adults who had received stem-cell transplantation for
hematological malignancies. Inclusion criteria for these patients
included low platelet count, hemolytic anemia (i.e., destruction of
red blood cells within small blood vessels) and the requirement
that the patients had not responded to attempted treatment of the
TMA with modification of their immunosuppressive drugs. Changing
the immunosuppressive regimen is common practice in HSCT patients
who develop a TMA, and those who do not respond to these drug
changes frequently die. Three HSCT-TMA patients, all of whom had
failed immunosuppressive modification, completed treatment with
OMS721 for up to 8 weeks. Two other patients discontinued OMS721
early in their treatment courses, one later relapsed and the
other’s treatment was changed to palliative care only.
Across all three patients completing treatment, mean TMA markers
improved over time. The mean LDH level decreased from a baseline of
672 U/L by as much as 380 U/L (p < 0.01). The mean haptoglobin
increased over 1.54 g/L from a baseline of 0.33 g/L (p < 0.06).
LDH and haptoglobin are measures of hemolytic anemia. The mean
platelet count increased as much as 57,000/μL from a baseline of
18,000/μL but did not reach statistical significance in this small
number of patients. Creatinine remained normal or improved, nearly
normalizing, in two patients; one did not show improvement in
creatinine but was receiving concomitant nephrotoxic drugs. On
extended follow up, two patients remain stable and one experienced
graft failure, which the investigator considers unrelated to OMS721
treatment.
No significant safety concerns have been observed. The most
commonly reported adverse events in these patients have been
abdominal pain, diarrhea, neutropenia and hypokalemia, all commonly
seen in this patient population. An abstract has been submitted for
presentation at the February 2017 Tandem Meeting of the American
Society of Blood and Marrow Transplantation and the Center for
International Blood and Marrow Transplant Research.
“These data are exciting,” stated Samer Khaled, M.D., Assistant
Clinical Professor of Hematology and Hematopoietic Cell
Transplantation at City Of Hope in Duarte, California, and OMS721
clinical investigator. “The response in our patient was impressive,
particularly since the patient had failed previous treatments.
Lectin pathway inhibition could play a role in other
post-transplant complications, and I look forward to continued
development of OMS721 in stem cell transplantation.”
Approximately 20,000 HSCT procedures are performed in the U.S.
annually, and TMA is reported to occur in approximately 10 to 25
percent of HSCT patients. TMA most commonly affects the kidney but
can also damage the lungs, gastrointestinal tract and central
nervous system. Mortality in patients who develop severe HSCT-TMA
is greater than 90 percent.
“In addition to the data being collected in aHUS patients, these
HSCT-TMA results expand the potential benefits of OMS721 to
multiple thrombotic microangiopathy indications,” stated Gregory A.
Demopulos M.D., chairman and chief executive officer
of Omeros. “Stem cell transplantation is an expanding field
and represents an attractive medical and commercial opportunity. We
plan to discuss with FDA and international regulatory agencies the
design of a single Phase 3 trial for HSCT-TMA and look forward to
OMS721 addressing the significant unmet needs of patients across a
wide range of hematologic, renal and other therapeutic
indications.”
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 with one evaluating OMS721 in glomerulonephropathies,
which has generated positive data in patients with immunoglobulin A
(IgA) nephropathy and with membranous nephropathy, and the other in
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-related 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, Omeros’ 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 August 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/20161020005973/en/
Cook Williams Communications, Inc.Jennifer Cook WilliamsInvestor
and Media Relations360.668.3701jennifer@cwcomm.org
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