-- Single Pivotal Study Needed for Phase 3 --
SEATTLE--(BUSINESS WIRE)--Mar. 8, 2016--
Omeros Corporation (NASDAQ: OMER), 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, today announced that it has initiated its Phase 3 OMS721
program for the treatment of atypical hemolytic uremic syndrome (aHUS)
after meeting with the U.S. Food and Drug Administration (FDA). OMS721
is Omeros’ lead human monoclonal antibody in its mannan-binding
lectin-associated serine protease-2 (MASP-2) program for the treatment
of thrombotic microangiopathies (TMAs), including aHUS. The FDA has
awarded OMS721 both orphan drug designation for the treatment of TMAs
and fast-track status for the treatment of aHUS.
The OMS721 Phase 3 program will consist of one clinical trial – a
single-arm (i.e., no control arm), open-label trial in patients with
newly diagnosed or ongoing aHUS. The clinical package for the biologics
license application (BLA) will be similar to that which formed the basis
of approval for Soliris® (eculizumab). For the BLA, safety of
OMS721 can be demonstrated in patients across a wide range of diseases
instead of only in those with aHUS, including additional renal diseases
for which Omeros is already enrolling a clinical trial. As a result,
collection of safety data is not expected to delay submission of the
BLA. Omeros also received agreement from FDA on its ongoing
manufacturing for both the Phase 3 program and commercialization of
OMS721 as well as on its nonclinical safety and toxicology plan, most of
which has already been successfully completed with no significant
adverse findings. Phase 3 enrollment is expected to begin later this
year and patients currently being treated in the Phase 2 trial are
likely to be included in the Phase 3 program.
Consistent with guidance from the FDA, Omeros plans to pursue
accelerated approval for OMS721 in aHUS. Similar to fast track, to
qualify for accelerated approval a drug must treat a serious condition
and generally provide a meaningful advantage over available therapies.
Accelerated approval allows a company to market a drug while it
continues to conduct confirmatory clinical assessment to obtain full
approval. Omeros believes that, based on ongoing clinical work and
well-accepted data directed to the targets for OMS721 (MASP-2) and for
Soliris (C5), the conditions for accelerated approval can be met for
OMS721.
“The meeting with FDA represents an important milestone in the ongoing
development program for OMS721 and helped to solidify further the
company’s strategy to achieve commercialization,” stated Gregory A.
Demopulos, M.D., chairman and chief executive officer of Omeros. “We
hear from aHUS patients and their physicians that additional treatment
options are needed. Omeros is dedicated to fulfilling that need and to
helping these patients as quickly as possible.”
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 initiated a Phase 3 clinical program for OMS721 in
atypical hemolytic uremic syndrome and is continuing its Phase 2 program
targeting thrombotic thrombocytopenic purpura and stem cell
transplant-related thrombotic microangiopathies. In addition, an OMS721
Phase 2 program has been initiated in 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,” “likely,” “look forward
to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,”
“would” and similar expressions. 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, and the risks,
uncertainties and other factors described under the heading “Risk
Factors” in the company’s filings with the Securities and Exchange
Commission on November 9, 2015. 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/20160308005682/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org