Omeros Announces Positive Data from Phase 2 Clinical Trial Evaluating PPAR-gamma Agonist in Cocaine Abuse
October 19 2016 - 7:00AM
Business Wire
-- Decreases Craving and Protects Brain
White Matter Integrity --
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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OmerosCook Williams Communications, Inc.Jennifer Cook
Williams, 360-668-3701Investor and Media
Relationsjennifer@cwcomm.org
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