-- Decreases Craving and Protects Brain White Matter Integrity --
SEATTLE--(BUSINESS WIRE)--Oct. 19, 2016--
Omeros Corporation (NASDAQ: OMER) today announced positive results from
a Phase 2 clinical trial evaluating the effects of a peroxisome
proliferator-activated receptor (PPAR)-gamma agonist in patients with
cocaine use disorder (CUD). The trial, designed and conducted by Joy M.
Schmitz, Ph.D. and her colleagues at the Center for Neurobehavioral
Research on Addiction, University of Texas Health Science Center –
Houston, demonstrates that the PPAR-gamma agonist reduces craving and
improves the integrity of brain white matter in patients with CUD. There
currently are no approved medications to treat cocaine addiction.
Omeros’ issued and pending patents in its OMS405 program cover the use
of any PPAR-gamma agonist, alone or in combination with other addiction
therapies, to treat all forms of addiction, including cocaine, nicotine,
opioids, alcohol and other substances of abuse as well as addictive or
compulsive behaviors.
In this double-blind, placebo-controlled Phase 2 clinical trial, 30
treatment-seeking CUD patients were randomized to receive either a
PPAR-gamma agonist (n=15) or placebo (n=15) daily for 12 weeks. Measures
of impulsivity, decision-making and cocaine craving were recorded at
multiple time points. A subgroup of 19 patients (10 placebo patients and
9 PPAR-gamma-treated patients) underwent brain scans using diffusion
tensor imaging (DTI) to measure white matter integrity before and after
the course of treatment.
The data reveal a statistically significant time-dependent reduction in
cocaine craving in PPAR-gamma-agonist-treated patients compared to
placebo controls. Treated patients also showed improvement in white
matter integrity in four target DTI regions of interest, specifically in
the corpus callosum and in two associated thalamic tracts. During
treatment, side effects reported were minimal and similar between the
PPAR-gamma agonist and placebo groups. These clinical findings are
consistent with results of earlier mechanistic and target-based
preclinical studies showing that PPAR-gamma agonists protect against
neuronal damage and block reinstatement of cocaine, heroin and alcohol
seeking in animal models of drug abuse.
The trial was funded in part by grants from the National Institute of
Drug Abuse. The results of the trial were recently presented at the 2016
College on Problems of Drug Dependence (CPDD) meeting held in Palm
Springs, CA. A manuscript detailing the findings has been submitted for
publication to a peer-reviewed journal.
“In drug abusers, cognitive decline associated with loss of neuronal
function is a major negative prognostic factor,” stated Joy M. Schmitz,
Ph.D., Louis A. Faillace Professor, Department of Psychiatry and
Behavioral Sciences and Director of the Center for Neurobehavioral
Research on Addiction at University of Texas Health Science Center –
Houston. “To our knowledge, this is the first pharmacological agent that
shows the combined potential of neuroprotection together with
anti-craving and relapse-preventing abilities. Omeros’ OMS405 program
represents an innovative approach to treating drug abuse, with the
combination of effects offering a unique advantage over other strategies
under investigation.”
“These clinical data are exciting and underscore the unique mechanism of
action of PPAR-gamma agonists in the treatment of cocaine abuse and
potentially other forms of addiction,” stated Gregory A. Demopulos M.D.,
chairman and chief executive officer of Omeros. “Currently there is no
treatment for cocaine addiction. PPAR-gamma agonists such as OMS405
could well prove to be unique and effective therapeutics for the
epidemic of cocaine abuse affecting over 15 million people worldwide.
Together with OMS527, our PDE7 inhibitor program, Omeros is establishing
a substantial position in the addiction space.”
About Omeros Corporation
Omeros is a biopharmaceutical company committed to discovering,
developing and commercializing both small-molecule and protein
therapeutics for large-market as well as orphan indications targeting
inflammation, coagulopathies and disorders of the central nervous
system. Part of its proprietary PharmacoSurgery® platform,
the company’s first drug product, OMIDRIA® (phenylephrine and
ketorolac injection) 1%/0.3%, was broadly launched in the U.S. in April
2015. OMIDRIA is the first and only FDA-approved drug (1) 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 and (2) that contains an NSAID for
intraocular use. In the European Union, the European Commission has
approved OMIDRIA for use in cataract surgery and lens replacement
procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil
constriction), and to reduce postoperative eye pain. Omeros has
clinical-stage development programs focused on: complement-related
thrombotic microangiopathies; complement-mediated
glomerulonephropathies; Huntington’s disease and cognitive impairment;
and addictive and compulsive disorders. In addition, Omeros has a
proprietary G protein-coupled receptor (GPCR) platform, which is making
available an unprecedented number of new GPCR drug targets and
corresponding compounds to the pharmaceutical industry for drug
development, and a platform used to generate antibodies.
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,” “look forward to,”
“may,” “plan,” “potential,” “predict,” “project,” “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, Omeros’ 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 August 9, 2016. 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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Source: Omeros Corporation
Omeros
Cook Williams Communications, Inc.
Jennifer Cook
Williams, 360-668-3701
Investor and Media Relations
[email protected]