SEATTLE, Feb. 19, 2015 /PRNewswire/ -- Omeros Corporation
(NASDAQ: OMER) today announced that it has completed dosing of the
low-dose cohort of patients in its ongoing Phase 2 clinical trial
evaluating the efficacy and safety of OMS721, the lead human
monoclonal antibody for its mannan-binding lectin-associated serine
protease-2 (MASP-2) program, in treating thrombotic
microangiopathies (TMAs). 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. All patients in this study cohort received
OMS721 and improvements were observed across TMA disease markers.
The investigators treating all of these patients at different sites
consider the improvements to be treatment-related and clinically
meaningful. Based on observations in this cohort, a European
investigator has requested that Omeros provide extended access to
OMS721 for compassionate use in his two study patients, both of
whom suffer from atypical hemolytic uremic syndrome (aHUS), a form
of TMA.
In the clinical trial, the first cohort consisted of three
patients treated with the lowest dose of OMS721. All three patients
have aHUS. Platelet count, serum lactate dehydrogenase (LDH), and
serum haptoglobin were measured as markers of disease activity.
When compared to baseline levels, platelet counts improved in all
patients. Serum LDH levels remained normal in one patient,
substantially decreased to close to the normal range in another and
remained elevated in the third. Haptoglobin improved in two
patients, normalizing in one. Creatinine levels in the one patient
with independent renal function also improved.
Under this program of extended access, the two patients treated
by the investigator requesting compassionate use will continue to
undergo current or higher dosing with OMS721. The third patient,
treated at a site other than that of the requesting investigator,
appeared clinically to no longer be in the acute phase of the
disease after treatment with OMS721. The patient subsequently
relapsed following cessation of OMS721 treatment. This patient was
discontinued from the trial for precautionary reasons because of a
serious adverse event – a localized inflammatory response often
related to certain types of infections, one of which the patient
previously had for three years while on immunosuppressive therapy.
Such infections are associated with widely used TNF-alpha-targeting
drugs. All data to date indicate no active infection in this
patient. No other significant safety issues were observed in either
this trial or in the previously completed Phase 1 program.
Consistent with the Phase 2 trial protocol, a pre-planned data
review by internal and external physicians resulted in a
recommendation to proceed with the planned dose escalation to the
mid-dose cohort.
Omeros has agreed to provide the requested access to OMS721 for
compassionate use, subject to approval from the applicable European
regulatory authority, which has indicated its interest in
facilitating the request. Notification of the investigator's
request for extended access was posted on clinicaltrials.gov, the
U.S. government's publicly accessible clinical trial registry
website. In response to interest generated by the posting, Omeros
is issuing this press release to provide more detailed information.
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 replacement (ILR) to maintain
pupil size by preventing intraoperative miosis (pupil constriction)
and to reduce postoperative ocular pain. Omeros is completing
preparations for a planned U.S. product launch in early 2015.
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
facts are forward-looking statements. Terms such as "anticipate,"
"believe," "could," "estimate," "expect," "goal," "intend," "may,"
"plan," "potential," "predict," "project," "should," "will,"
"would," and similar expressions and variations thereof are
intended to identify forward-looking statements, but these terms
are not the exclusive means of identifying such statements.
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 begin U.S. commercial sales of
Omidria™ (OMS302) in early 2015, 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 Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on November 10, 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/omeros-corporations-phase-2-oms721-trial-resulting-in-extended-access-for-compassionate-use-300038375.html
SOURCE Omeros Corporation