Omeros Obtains Approval to Initiate Phase 1 Clinical Trial for its OMS527 Addiction Treatment
June 27 2018 - 9:15AM
Business Wire
– First Clinical Target for PDE7 Inhibitor
to be Nicotine Addiction –
Omeros Corporation (NASDAQ: OMER) today announced that it has
obtained regulatory authority and ethics committee clearance to
start the Phase 1 clinical trial evaluating its lead
phosphodiesterase 7 (PDE7) inhibitor from the company’s OMS527
program. Omeros discovered the link between PDE7 and addiction, and
the company holds broad patents internationally directed to PDE7
inhibitors for the treatment of all addictions and compulsive
disorders. The Phase 1 clinical trial will evaluate the safety,
tolerability, pharmacodynamics and pharmacokinetics of the compound
in healthy subjects. First subject dosing is expected next month.
Following Phase 1 completion, Omeros plans to conduct its initial
OMS527 Phase 2 clinical trial in patients with nicotine
addiction.
As previously reported, Omeros also identified the mechanism by
which its proprietary PDE7 inhibitors modulate dopamine levels in
the areas of the brain responsible for addiction. The dopamine
system is well recognized as the brain’s primary driver in drug
addiction and compulsive disorders. In animal models, Omeros’ PDE7
inhibitors reduce craving and relapse across multiple drugs of
abuse, including nicotine, cocaine, opioids and alcohol, and also
block binge eating. Importantly, PDE7 inhibitors do not appear to
be addictive nor to depress pleasure from normal activities, each
of which are often shortcomings of current commercial addiction
therapies.
Tens of millions of people in the U.S. suffer from substance
addiction, with an estimated societal cost of nearly $1 trillion.
For nicotine addiction alone, the estimated annual cost to society
in the U.S. is over $300 billion.
“We look forward to initiating human dosing of OMS527,” stated
Gregory A. Demopulos, M.D., chairman and chief executive officer of
Omeros. “The monetary and societal costs of addictions and
compulsions globally are staggering and continue to grow. These
disorders represent an enormous and urgent unmet need, with
currently available treatment regimens falling short. We’re excited
about the prospects of PDE7 inhibition to change fundamentally that
treatment paradigm.”
About Omeros CorporationOmeros 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 StatementsThis 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/20180627005473/en/
Cook Williams Communications, Inc.Jennifer Cook WilliamsInvestor
and Media Relations360.668.3701jennifer@cwcomm.org
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