-- Study Provides an Opportunity for Breakthrough Therapy Designation
and Subsequent Accelerated Approval --
SEATTLE--(BUSINESS WIRE)--Apr. 20, 2016--
Omeros Corporation (NASDAQ: OMER) today announced initiation of patient
dosing in its OMS721 Phase 2 program in corticosteroid-dependent renal
diseases. The Phase 2 clinical trial of OMS721, the company’s lead
mannan-binding lectin-associated serine protease-2 (MASP-2) inhibitor
being developed for complement-related diseases, is evaluating the
effects of OMS721 on kidney function in patients with
corticosteroid-dependent renal diseases. This new trial expands the
company’s MASP platform, which includes an OMS721 Phase 3 program in
progress for the treatment of atypical hemolytic uremic syndrome (aHUS)
as well as an ongoing Phase 2 program of OMS721 for the treatment of
other thrombotic microangiopathies (TMAs).
This new Phase 2 clinical trial includes patients with
corticosteroid-dependent IgA nephropathy, membranous nephropathy, C3
glomerulopathy and lupus nephritis. Evidence implicates the complement
system, and specifically the lectin pathway, in the pathogenesis of each
of these serious diseases. Despite ongoing treatment with
corticosteroids, these patients have evidence of progressive kidney
disease and are at high risk for kidney failure and dialysis. Continued
corticosteroid use carries significant patient risks and is associated
with serious side effects. There are no FDA-approved treatments for
corticosteroid-dependent patients who have persistent renal
inflammation. Treatments for these diseases that improve kidney
function, slow disease progression or avoid long-term corticosteroid use
would meet a significant unmet medical need.
The Phase 2 clinical trial is enrolling a total of approximately 16
patients across separate cohorts for each disease. The trial is
evaluating markers of kidney injury and will assess whether OMS721
allows a reduction in diseased patients’ corticosteroid requirements.
Patients will receive 12 weeks of OMS721 treatment and will undergo
protocol-prescribed corticosteroid tapering. Data from this trial are
expected in the second half of this year or the first half of 2017.
Given the seriousness of the diseases included in this Phase 2 program
and the lack of available therapies, if this trial demonstrates evidence
that OMS721 improves kidney function, slows disease progression or
reduces corticosteroid use in these patients, Omeros intends to request
breakthrough therapy designation from the FDA and to initiate a Phase 3
program that meets the requirements for accelerated approval.
“We are making excellent progress in our Phase 2 program in
corticosteroid-dependent renal diseases,” stated Gregory A. Demopulos,
M.D., chairman and chief executive officer of Omeros. “These are
devastating diseases – patients are at high risk and need treatment
options. Providing a treatment benefit to any of these patient groups
would be a major therapeutic advance. Given the severity of disease,
similar to our OMS721 Phase 3 aHUS program, treatment effects can be
identified in small numbers of patients without a control group. This is
consistent with our OMS721 strategy of targeting rare diseases for which
our drug could have a meaningful impact on quality of life.”
About Omeros’ MASP 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
appears to be unique to, and required for the function of, one of the
principal complement activation pathways, known as the lectin pathway.
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 is
associated with a wide range of autoimmune disorders. 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. Omeros has an
ongoing Phase 3 clinical program for OMS721 in atypical hemolytic uremic
syndrome, an ongoing Phase 2 program targeting thrombotic
thrombocytopenic purpura and stem cell transplant-related thrombotic
microangiopathies and an ongoing Phase 2 program targeting
complement-related renal diseases. An investigator-requested
compassionate use program for OMS721 is also underway. OMS721 has
demonstrated no safety concerns in human trials or chronic toxicity
studies. In addition to potential intravenous administration, Omeros
plans to commercialize OMS721 for one or more therapeutic indications as
a subcutaneous injection.
Omeros also believes that it has identified the proteins that activate
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’s OMS906 program is advancing the
development of antibodies targeting MASP-3 that 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. Derived from 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 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. 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 five clinical-stage development programs focused on:
complement-related thrombotic microangiopathies; complement-mediated
glomerulopathies; Huntington’s disease and cognitive impairment;
addictive and compulsive disorders; and preventing problems associated
with urologic surgical procedures. In addition, Omeros has a proprietary
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 including with respect to
OMIDRIA®, Omeros’ ability to partner and commercialize
OMIDRIA in Europe, Omeros’ unproven preclinical and clinical development
activities, regulatory oversight, intellectual property claims,
competitive developments, litigation including pending patent litigation
related to an application seeking approval from the FDA to market a
generic version of OMIDRIA, and the risks, uncertainties and other
factors described under the heading “Risk Factors” in the company’s
Annual Report on Form 10-K filed with the Securities and Exchange
Commission on March 15, 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/20160420005585/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org
