SEATTLE, Sept. 12, 2013 /PRNewswire/ -- Omeros Corporation
(NASDAQ: OMER) today announced positive data from the Company's
Phase 1 clinical trial evaluating the pharmacokinetics of OMS824,
the lead compound in Omeros' phosphodiesterase 10 (PDE10) program,
further supporting that OMS824 can achieve superior target
engagement with lesser side effects compared to other PDE10
inhibitors in development. With these data and the previously
announced encouraging results from the OMS824 positron emission
tomography (PET) clinical trial, Omeros is advancing OMS824 into
Phase 2 clinical programs. OMS824 selectively inhibits PDE10, an
enzyme expressed in areas of the brain linked to a wide range of
diseases that affect cognition, including Huntington's disease and
schizophrenia.
The OMS824 Phase 1 clinical trial included single- and
multiple-dose escalation studies that enrolled 100 healthy male
subjects: 60 subjects received a single dose of OMS824, 24 subjects
received multiple doses for seven to 10 days, and 16 subjects
received placebo. The data announced today are at the highest
multiple-dose level administered and, at this dose, OMS824 was well
tolerated and the only apparent drug-related adverse events were
mild. Almost all adverse events were self-limiting, resolving
during the 10-day dosing period. In May of this year, Omeros
reported that a lower dose evaluated in an ongoing PET clinical
trial demonstrated target engagement greater than had previously
been reported for any PDE10 inhibitor (an average of approximately
50-percent and a maximum of approximately 70-percent engagement)
without the dose-limiting side effects seen with other PDE10
inhibitors. Pharmacokinetic data at the high dose announced today
showed an approximately two-fold increase in plasma concentration
over that of the dose used in the earlier-reported PET trial. This
same high dose level is scheduled to be evaluated in the ongoing
PET trial and is expected to demonstrate substantially higher
target engagement. The Phase 1 clinical trial results predict that
OMS824, at well-tolerated doses, will effectively inhibit PDE10 and
support continuing development for the treatment of Huntington's
disease, schizophrenia and other central nervous system
disorders.
"These findings are unprecedented based on our knowledge of the
work to date in the area of PDE10 inhibition and could result in a
significant competitive advantage across a range of CNS
indications," stated Gregory A.
Demopulos, M.D., chairman and chief executive officer of
Omeros. "With this further confirmation of the unique pharmacology
of our PDE10 inhibitor, Omeros is well positioned to initiate Phase
2 programs in schizophrenia and Huntington's disease before
year-end."
About Omeros' PDE10 Program
PDE10 is an enzyme that is
expressed in areas of the brain linked to diseases that affect
cognition and psychomotor functions, including Huntington's disease
and schizophrenia. Huntington's disease is a hereditary
neurodegenerative disorder that leads to movement, cognition, and
behavioral abnormalities and premature death. Schizophrenia is a
group of severe brain disorders characterized by an abnormal
interpretation of reality, which can manifest as delusions,
hallucinations, and/or disordered thinking and behavior. Cognitive
dysfunction is responsible for substantial disability in both of
these diseases and is not meaningfully improved by current
medications. Omeros' proprietary compound OMS824 inhibits PDE10 and
is being developed for the treatment of cognitive disorders. In
addition to potential benefits on cognition, OMS824 could also
improve the motor and psychiatric abnormalities in Huntington's
disease as well as the positive (e.g., hallucinations) and negative
(e.g., flat affect) symptoms of schizophrenia.
About Omeros Corporation
Omeros is a clinical-stage
biopharmaceutical company committed to discovering, developing and
commercializing products targeting inflammation, coagulopathies and
disorders of the central nervous system. The Company's most
clinically advanced product candidates, OMS302 for lens replacement
surgery and OMS103HP for arthroscopy, are derived from its
proprietary PharmacoSurgery® platform designed to improve clinical
outcomes of patients undergoing a wide range of surgical and
medical procedures. Omeros has six clinical development programs.
Omeros may also have the near-term capability, through its GPCR
program, to add a large number of new drug targets and their
corresponding compounds to the pharmaceutical industry. Behind its
clinical candidates and GPCR platform, Omeros is building a diverse
pipeline of protein and small-molecule preclinical programs
targeting inflammation, coagulopathies and central nervous system
disorders.
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. These statements include, but
are not limited to, Omeros' expectations regarding the potential
competitive advantages of OMS824, including its therapeutic
benefits; that it will advance OMS824 into Phase 2 clinical
programs for Huntington's disease and schizophrenia before year
end; regarding the potential qualities of OMS824; regarding
demonstration of target engagement in the PET trial; and that it
may have capability, through its GPCR program, to add a large
number of new drug targets and their corresponding compounds to the
pharmaceutical industry. 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, 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 August 9,
2013. 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 publicly, even if new information
becomes available in the future.
SOURCE Omeros Corporation