-- Phase 3 Clinical Program Planned for 2017 --
SEATTLE--(BUSINESS WIRE)--Oct. 31, 2016--
Omeros Corporation (NASDAQ: OMER) today announced that it has requested
fast track designation from the U.S. Food and Drug Administration (FDA)
for the development of OMS721 for the treatment of patients with
immunoglobulin A (IgA) nephropathy (also known as Berger’s disease). The
company recently reported positive data (p = 0.017) from the company’s
Phase 2 clinical trial of OMS721 for the treatment of kidney disorders,
including IgA nephropathy, none of which currently have an approved
treatment and all of which frequently lead to end-stage renal disease
and dialysis. OMS721 significantly improved key endpoints of renal
function and patients achieved partial remission with just 12 weeks of
dosing. With similar outcomes in additional patients, the company plans
to pursue accelerated approval. 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.
FDA’s fast track program streamlines the development of drugs intended
to treat serious or life-threatening conditions and that have the
potential to address unmet medical needs. Fast track drugs are eligible
for more frequent and timely meetings with FDA to discuss the
development plan and to ensure that data needed for approval are
collected appropriately. Drugs in the fast track program typically are
granted priority review status and their respective New Drug
Applications are accepted and reviewed by the FDA as rolling
submissions. If granted, fast track designation is expected to expedite
Omeros’ Phase 3 program for OMS721 in IgA nephropathy, which is planned
to initiate next year.
FDA already has granted fast track designation for OMS721 in patients
with atypical hemolytic uremic syndrome (aHUS) and orphan designation
for OMS721 in patients with thrombotic microangiopathies (TMAs),
including aHUS and hematopoietic stem cell-associated TMAs (HSCT-TMAs).
In addition to positive Phase 2 data in IgA nephropathy and membranous
nephropathy, Omeros has reported positive data from Phase 2 clinical
trials in both aHUS and HSCT-TMAs. Following guidance from FDA and from
the European Medicines Agency, Omeros plans to open enrollment for its
single Phase 3 trial in patients with aHUS later this year. Based on
discussions with the FDA, the company is also pursuing breakthrough
therapy designation for OMS721 in IgA nephropathy and in HSCT-TMAs,
neither of which has any approved treatment.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161031005457/en/
Source: Omeros Corporation
For Omeros Corporation
Cook Williams Communications, Inc.
Jennifer
Cook Williams
Investor and Media Relations
360.668.3701
jennifer@cwcomm.org
