- Omeros’ Second Phase 3 Clinical Program for OMS721 Slated to Begin
this Year -
SEATTLE--(BUSINESS WIRE)--Jun. 13, 2017--
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170613005978/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org
