– First Clinical Target for PDE7 Inhibitor to be Nicotine Addiction –
SEATTLE--(BUSINESS WIRE)--Jun. 27, 2018--
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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180627005473/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org
