SEATTLE, April 14, 2015 /PRNewswire/ -- Omeros
Corporation (NASDAQ: OMER) today announced that the presiding
European regulatory authority has approved the company's
investigational product OMS721 for compassionate use. 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
atypical hemolytic uremic syndrome (aHUS). TMAs are a family of
rare, debilitating and life-threatening disorders characterized by
excessive thrombi (clots) in the microcirculation of the body's
organs, most commonly the kidney and brain.
The two patients in the compassionate-use study suffer from aHUS
and were enrolled in the first cohort of the Phase 2 clinical
trial. Based on improvements across markers of disease activity in
that cohort, the investigator requested that Omeros continue to
provide OMS721 so that the patients could extend their treatments.
Following regulatory approval, Omeros was pleased to release
shipment of OMS721 to continue treatment of these patients.
Omeros' ongoing OMS721 Phase 2 study continues to progress
through its dose-ranging phase. The second cohort of patients,
which received a higher dose than the first cohort, has now
completed treatment. Following a pre-planned data review by
internal and external physicians, if the safety data from the
second cohort are acceptable, a recommendation will be made to
advance as scheduled to a third cohort at an even higher dose. This
third cohort could begin dosing before the end of April.
"We are pleased to extend OMS721 treatment for patients
suffering with TMAs beyond the initial planned duration of the
Phase 2 study," stated Gregory A.
Demopulos, M.D., Chairman and Chief Executive Officer of
Omeros. "We are excited by the progress our OMS721 Phase 2 program
and look forward to its continued advancement following the
second-cohort data review."
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 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 biopharmaceutical
company committed to discovering, developing and commercializing
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%, has been approved by the FDA 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. Omidria is
currently under review for marketing approval by the European
Medicines Agency. Omeros has six clinical-stage development
programs focused on: complement-related thrombotic
microangiopathies; Huntington's disease, schizophrenia, and
cognitive impairment; addictive and compulsive disorders; and
preventing problems associated with 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.
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 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 16, 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.
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SOURCE Omeros Corporation