Omeros Initiates Dosing in Phase 1 Clinical Trial for OMS527 Targeting Addiction
July 17 2018 - 7:00AM
Business Wire
-- Nicotine Addiction Planned as First
Indication --
Omeros Corporation (NASDAQ: OMER) today announced that the first
cohort of subjects has been dosed in the Company’s Phase 1 clinical
trial, evaluating the lead phosphodiesterase 7 (PDE7) inhibitor in
Omeros’ OMS527 program broadly targeting addictions and compulsive
disorders. Inhibitors of PDE7 have been demonstrated to modulate
the brain’s dopamine levels, widely recognized as central to both
addictive and compulsive disorders. The trial remains on track to
deliver escalating single and multiple doses of the drug.
With preclinical data showing efficacy in multiple types of
addiction and compulsive disorders, the initial target planned for
OMS527 is nicotine addiction. The single largest preventable cause
of death and disease in the U.S. is tobacco use, with a national
death toll of nearly half a million people annually.
Smoking-related illness in the U.S. costs over $300 billion a year
and, in 2016, an estimated 38 million adults in the U.S. were
current cigarette smokers.
The Phase 1 clinical trial, conducted in healthy subjects, is
designed to assess the safety and pharmacokinetics (i.e., blood
levels of the drug and its clearance from the body) of OMS527
administered in varying doses and formulations. Omeros discovered
the links between PDE7 and addictions, compulsive behaviors and
movement disorders, and the company controls a broad patent estate
globally directed to any PDE7 inhibitor for their respective
treatment.
Completion of the Phase 1 single-ascending- and
multiple-ascending-dose trial for OMS527 is expected in the first
half of 2019.
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed
to discovering, developing and commercializing small-molecule and
protein therapeutics for large-market as well as orphan indications
targeting inflammation, complement-mediated diseases and disorders
of the central nervous system. The company’s drug product OMIDRIA®
(phenylephrine and ketorolac intraocular solution) 1% / 0.3% is
marketed 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. In the European Union, the European Commission has approved
OMIDRIA for use in cataract surgery and other IOL replacement
procedures to maintain mydriasis (pupil dilation), prevent miosis
(pupil constriction), and to reduce postoperative eye pain. Omeros
has multiple Phase 3 and Phase 2 clinical-stage development
programs focused on: complement-associated thrombotic
microangiopathies; complement-mediated glomerulonephropathies;
cognitive impairment; and addictive and compulsive disorders. In
addition, Omeros has a diverse group of preclinical programs and a
proprietary G protein-coupled receptor (GPCR) platform through
which it controls 54 new GPCR drug targets and corresponding
compounds, a number of which are in preclinical development. The
company also exclusively possesses a novel antibody-generating
platform.
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,” “likely”, “look forward to,” “may,” “plan,”
“potential,” “predict,” “project,” “prospects,” “should,” “will,”
“would” and similar expressions and variations thereof.
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 product commercialization and commercial
operations, unproven preclinical and clinical development
activities, regulatory oversight, 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 May 10, 2018. 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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version on businesswire.com: https://www.businesswire.com/news/home/20180717005339/en/
Cook Williams Communications, Inc.Jennifer Cook WilliamsInvestor
and Media Relations360.668.3701jennifer@cwcomm.org
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