SEATTLE, April 3, 2014 /PRNewswire/ -- Omeros
Corporation (NASDAQ: OMER) today announced that its Investigational
New Drug Application (IND) to evaluate OMS721 for the inhibition of
complement‑mediated thrombotic microangiopathies (TMAs) has been
cleared by the U.S. Food and Drug Administration (FDA). OMS721 is
the company's lead human monoclonal antibody targeting
mannan-binding lectin-associated serine protease-2 (MASP-2), the
key regulator of the lectin pathway of the immune system. Omeros
announced last year that the FDA granted OMS721 Orphan Drug
designation for the inhibition of complement‑mediated TMAs, a
family of rare, debilitating and life-threatening disorders
characterized by multiple thrombi (clots) in the microcirculation
of the body's organs, most commonly the kidney and brain.
FDA's clearance of the IND allows the initiation of the Phase 2
program for OMS721, which will assess the efficacy and safety of
OMS721 in patients with disorders associated with lectin pathway
activation. The first OMS721 Phase 2 clinical trial, planned to
begin later this quarter, will evaluate the effects of the drug on
patients with TMAs, including atypical hemolytic uremic syndrome
(aHUS), thrombotic thrombocytopenic purpura (TTP), and stem cell
transplant-related TMA. The lectin pathway, one of the principal
complement activation pathways in the immune system, is thought to
play a central role in the development of TMAs, and OMS721, by
targeting and inhibiting MASP-2, blocks the lectin pathway. Last
month, the company reported positive data in serum samples from
aHUS patients indicating that the lectin pathway, and MASP-2
specifically, are involved in the pathophysiology of aHUS. In those
studies, OMS721 significantly inhibited complement deposition both
in the acute phase of the disease and during remission, and its
inhibitory effect was similar to that of agents that block
complement factor C5. Eculizumab (Soliris®), a C5
monoclonal antibody for the treatment aHUS, is the only
commercially available complement inhibitor. Omeros controls the
worldwide rights to MASP-2 inhibition and to all therapeutics
targeting MASP-2.
"FDA's decision clears the way for us to begin the Phase 2
program for OMS721," stated Gregory A.
Demopulos, M.D., chairman and chief executive officer of
Omeros. "We are excited by the data in serum samples from aHUS
patients, and we look forward to reporting results from our Phase 2
clinical trial in patients with aHUS and other TMAs later this
year."
About Omeros' MASP-2 Program
Omeros controls the worldwide rights to MASP-2 inhibition and to
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 its abnormal function is
associated with a wide range of autoimmune disorders. MASP-2 is
generated by the liver and is then released into the 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. Therefore, Omeros believes that it may be possible
to deliver MASP-2 antibodies systemically and OMS721, its lead
MASP-2 antibody, is designed to be self-administered by
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 is advancing
the development of antibodies that would block activation of the
alternative pathway alone or in combination with the lectin
pathway.
About Omeros Corporation
Omeros is a clinical-stage biopharmaceutical company committed
to discovering, developing and commercializing small-molecule and
protein therapeutics targeting inflammation, coagulopathies and
disorders of the central nervous system. Derived from its
proprietary PharmacoSurgery® platform, the Company's
lead drug product, Omidria™ (OMS302) for lens
replacement surgery, is currently under review for marketing
approval by both the US Food and Drug Administration and the
European Medicines Agency with US commercial launch planned for the
second half of 2014. Omeros' six other clinical programs are
focused on schizophrenia, Huntington's disease and cognitive
impairment; addictive and compulsive disorders; complement-related
diseases; and preventing problems associated with surgical
procedures. Omeros also 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.
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. 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 Omeros' ability to obtain
regulatory approval for its New Drug Application in the US and its
Marketing Authorization Application in the EU for the
commercialization of Omidria, Omeros' unproven preclinical and
clinical development activities, regulatory oversight, product
commercialization, intellectual property claims, competitive
developments, litigation, 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 13, 2014. 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.
SOURCE Omeros Corporation