Omeros Reports Initiation of Phase 2 Clinical Trial with OMS824

       Omeros Reports Initiation of Phase 2 Clinical Trial with OMS824

-- PDE10 Inhibitor Administered to Patients with Schizophrenia --

PR Newswire

SEATTLE, Sept. 19, 2013

SEATTLE, Sept. 19, 2013 /PRNewswire/ -- Omeros Corporation (NASDAQ:OMER) today
announced initiation of enrollment in a Phase 2 clinical trial of OMS824, the
company's phosphodiesterase 10 (PDE10) inhibitor. The trial will evaluate the
compound's tolerability, safety, pharmacokinetics, potential interactions with
concomitant antipsychotic medications, and a battery of cognitive tests in
patients with stable schizophrenia.

The Phase 1 clinical program in healthy subjects established dosing regimens
that were well tolerated and associated with high levels of PDE10 target
engagement in the brain, supporting advancement of OMS824 into
patient-directed trials. In this Phase 2 clinical trial, OMS824 will be
administered at various dose levels for two weeks to patients whose
antipsychotic medications have been temporarily discontinued or who continue
their usual antipsychotic regimen in order to assess the effects of OMS824 as
monotherapy and in combination with antipsychotic medications. A variety of
cognitive tests will be assessed, although the relatively small size of this
trial will limit the ability to detect treatment effects, if present. The
safety and any efficacy findings in this trial are planned for use in
determining appropriate dosing regimens and selecting endpoints for subsequent
Phase 2 and Phase 3 clinical trials in schizophrenia. Those trials are
expected to evaluate OMS824 in schizophrenic patients who are psychiatrically
stable with cognitive impairment, in patients with acute exacerbation of
symptoms, and/or in patients with inadequate response to antipsychotic
medications.

"We are excited to begin assessing OMS824 in patients suffering with
schizophrenia," stated Gregory A. Demopulos, M.D., chairman and chief
executive officer of Omeros. "This Phase 2 trial will provide us with
important information on our compound's safety and, potentially, efficacy for
additional Phase 2 trials in schizophrenia and Huntington's disease. We look
forward to completing the current trial later this year."

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 subsequent Phase 2 and 3 clinical trials;
the timing of completion of the current trial; the potential therapeutic
benefits of OMS824; the potential qualities of OMS824; 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

Contact: Jennifer Cook Williams, Cook Williams Communications, Inc., Investor
and Media Relations, 360.668.3701, jennifer@cwcomm.org
 
Press spacebar to pause and continue. Press esc to stop.