- Omeros’ Second Phase 3 Clinical Program for
OMS721 Slated to Begin this Year -
Omeros Corporation (NASDAQ: OMER) today announced that the US
Food and Drug Administration (FDA) has granted breakthrough therapy
designation to OMS721 for the treatment of Immunoglobulin A (IgA)
nephropathy. 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.
Breakthrough therapy designation was granted based on data from
Omeros’ Phase 2 clinical trial evaluating OMS721 in patients with
IgA nephropathy and other kidney diseases. The data were recently
presented at the 54th European Renal Association-European Dialysis
and Transplant Association (ERA-EDTA) Congress in Madrid.
Proteinuria is an important marker for disease progression in
patients with IgA nephropathy, and improvement in proteinuria is
associated with improved clinical outcomes. The clinical trial data
show unprecedented improvement in proteinuria following only 12
weeks of OMS721 treatment, with a 77-percent mean reduction in
urine albumin-to-creatinine ratios (p = 0.026) and a 73-percent
mean reduction in 24-hour urine protein levels (p = 0.013). In
response, many physicians attending ERA-EDTA in Madrid and
representing centers across Europe, the U.S. and Asia that manage
large numbers of IgA nephropathy patients asked to participate in
Omeros’ planned Phase 3 clinical trial. These physicians have been
added to the ongoing clinical site evaluation for the Phase 3
clinical program.
FDA’s breakthrough therapy designation enables expedited
development and review of a drug candidate for the treatment of a
serious or life-threatening disease. Preliminary clinical evidence
indicating that the drug may demonstrate substantial improvement
over existing therapies is required. Benefits of breakthrough
therapy designation include the eligibility for priority review of
the application and rolling submission of portions of the
application. FDA personnel, including senior management, provide
guidance to the company to determine the most efficient route to
approval. OMS721 is the only drug candidate in development for the
treatment of IgA nephropathy that has been granted breakthrough
therapy designation by FDA.
“We are pleased that FDA has granted breakthrough designation to
OMS721 for IgA nephropathy and appreciate the Agency’s recognition
of the potential importance of OMS721 in the treatment of this
disease,” stated Gregory A. Demopulos, M.D., chairman and chief
executive officer of Omeros. “OMS721 appears to be helping IgA
nephropathy patients with a rapidity and magnitude not previously
seen with any other therapy, and we look forward to working closely
with the FDA to accelerate its development.”
There is no approved treatment for IgA nephropathy. The most
common primary glomerulopathy globally, it accounts for up to 10
percent of all dialysis patients. In the U.S. alone, an estimated
120,000 to 180,000 patients have this disease. Approximately 40
percent of IgA nephropathy patients develop end-stage renal
disease, a life-threatening condition, within 20 to 30 years
following diagnosis.
OMS721 is also being evaluated in a Phase 3 clinical program for
atypical hemolytic uremic syndrome and in a Phase 2 clinical
program for hematopoietic stem cell transplant-associated
thrombotic microangiopathy.
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 and with lupus
nephritis; the other has reported positive data both in patients
with hematopoietic stem cell transplant-associated thrombotic
microangiopathy (TMA) and in those with aHUS. One or more
additional OMS721 Phase 3 clinical programs are planned to initiate
this year in IgA nephropathy and in stem cell transplant-associated
TMA. OMS721 can be administered intravenously, and Omeros also
expects to commercialize OMS721 for one or more therapeutic
indications as a subcutaneous injection. In parallel, Omeros is
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 breakthrough therapy
designation for IgA nephropathy, 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 responsible for the
conversion of pro-factor D to factor D and as a critical activator
of the human complement system’s alternative pathway. The
alternative pathway 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. Omeros is preparing to initiate manufacturing
scale-up of its MASP-3 antibodies in advance of clinical
trials.
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 multiple Phase 3 and
Phase 2 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 and controls 54 new GPCR drug targets and
corresponding compounds, a number of which are in preclinical
development. The company also exclusively possesses a novel
antibody-generating platform.
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 May 10,
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/20170613005978/en/
Cook Williams Communications, Inc.Jennifer Cook WilliamsInvestor
and Media Relations360.668.3701jennifer@cwcomm.org
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