Single Dose of Omeros’ Lead MASP-3 Inhibitor OMS906 Shows Multi-Week Blockade of the Alternative Pathway
November 10 2016 - 7:00AM
Business Wire
-- Non-Human Primate Data Support Advancing
to Clinic --
Omeros Corporation (NASDAQ: OMER) today announced
pharmacokinetic and pharmacodynamic data from the evaluation of
OMS906 in non-human primates. OMS906 inhibits mannan-binding
lectin-associated serine protease-3 (MASP-3), the protein critical
to activation of the alternative pathway of complement (APC), a key
component of the immune system. MASP-3 is responsible for the
conversion of pro-factor D to factor D. Converted factor D is
necessary for the activation of the APC. The APC is involved in a
wide range of diseases, including paroxysmal nocturnal
hemoglobinuria (PNH), atypical hemolytic uremic syndrome,
age-related macular degeneration, arthritis, asthma and traumatic
brain injury.
Single-dose administration of OMS906 to cynomolgus monkeys
resulted in sustained ablation of systemic APC activity for
approximately 16 days. The extent of APC ablation was comparable to
that achieved by complete inhibition of factor D in vitro,
indicating that OMS906 fully blocked the conversion of pro-factor D
to factor D. Similar results were obtained with a number of the
company’s other antibodies targeting MASP-3. No safety concerns
were identified.
The primate data are consistent with recently reported results
from well-established animal models in which OMS906 reduced the
incidence and severity of arthritis by 86 percent (p < 0.005)
and 90 percent (p < 0.01), respectively, and significantly
improved the survival of PNH-like red blood cells approximately
four-fold better (p = 0.029) than did a complement factor 5 (C5)
inhibitor.
“The OMS906 primate data bode well for the antibody’s
long-acting inhibition of MASP-3 in patients, and the unique
mechanism of action of MASP-3 inhibition likely has significant
clinical advantages over many other alternative pathway
inhibitors,” said Sir Peter Lachmann, ScD FRCP FRCPath FRS FMedSci,
Emeritus Sheila Joan Smith Professor of Immunology, University of
Cambridge. “In PNH, the MASP-3 inhibitor OMS906 blocks not only
intravascular hemolysis, as do C5 inhibitors, but also prevents
extravascular hemolysis, a problem that C5 inhibition cannot
address. Other alternative pathway targets, such as factor D or
factor B, turn over at extremely high rates, making them difficult
to drug. In contrast, MASP-3 circulates in the body at a relatively
low concentration with a slow rate of turnover, enabling sustained
inhibition by either MASP-3-targeting antibodies or small
molecules.”
Omeros exclusively controls the use of MASP-3 inhibitors for the
treatment of APC-related diseases and disorders. The company is
initiating the manufacturing scale-up process for OMS906 in
preparation for clinical trials.
About Omeros’ MASP-3 Inhibitor Program
The complement system plays a key role in inflammation and
becomes activated as a result of tissue damage or microbial
infection. Omeros’ MASP-3 inhibitor program includes potent
molecules selectively inhibiting mannan-binding lectin-associated
serine protease-3 (MASP-3), the protein responsible for processing
Factor D, which is essential for activation of the alternative
pathway of complement (APC). APC inhibitors are thought to have
preventive or therapeutic effects across a broad range of diseases
including hemolytic uremic syndrome (HUS), atypical HUS, paroxysmal
nocturnal hemoglobinuria, traumatic brain injury, arthritis, wet
age-related macular degeneration, ischemia-reperfusion injury,
transplant-related complications and other immune-related
disorders. Omeros is developing both antibodies and small molecules
to block MASP-3. Through its OMS906 and OMS721 programs and
patents, Omeros exclusively controls inhibitors of MASP-3, the
protein critical to the activation of the alternative pathway, and
inhibitors of MASP-2, the effector enzyme of the lectin pathway.
Collectively, the company is able to target, with unprecedented
precision, diseases caused by dysregulation of one or both of these
pathways.
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-associated 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 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 November
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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version on businesswire.com: http://www.businesswire.com/news/home/20161110005641/en/
Cook Williams Communications, Inc.Jennifer Cook Williams,
360-668-3701Investor and Media Relationsjennifer@cwcomm.org
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