-- Non-Human Primate Data Support Advancing to Clinic --
SEATTLE--(BUSINESS WIRE)--Nov. 10, 2016--
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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Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams,
360-668-3701
Investor and Media Relations
jennifer@cwcomm.org