Omeros Announces Preliminary Results from Phase 1 Clinical Trial of OMS906
June 09 2021 - 7:45AM
Business Wire
-- Results show good safety and PK/PD profile
consistent with low-dose, once-monthly subcutaneous dosing --
Omeros Corporation (Nasdaq: OMER), 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,
immunologic diseases (e.g., complement-mediated diseases and
cancers) and central nervous system disorders, today announced
preliminary results from the Phase 1 clinical trial of its MASP-3
inhibitor OMS906. The ongoing trial is designed as a randomized,
double-blind, placebo-controlled study to assess the safety,
tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of
intravenous (IV) and subcutaneous (SC) administration of OMS906 to
healthy adult volunteers. OMS906 has been well tolerated at all
doses tested. Preliminary human PK and PD data are consistent with
once-monthly SC dosing.
MASP-3, the key activator of the alternative pathway of
complement, converts pro-complement factor D (pro-CFD) to mature
CFD. Inhibition of MASP-3 by OMS906 in nonhuman primates reduces
systemic levels of mature CFD to below the threshold of detection,
correspondingly blocking the alternative pathway of complement. The
OMS906 Phase 1 clinical trial design consists of both single- and
multiple-ascending dose cohorts. Pharmacodynamic response to OMS906
in the Phase 1 trial is being assessed by quantitation of mature
CFD in plasma. In the single-ascending dose stage, 48 subjects have
been evaluated to date across a series of IV and SC doses. Findings
include:
- OMS906, administered up to 5 mg/kg, has been well tolerated at
all IV and SC doses tested with no apparent safety signals
- Single 3 mg/kg IV dose of OMS906 suppresses mature CFD below
minimum detectable levels for 4 weeks
- Single lowest SC dose of OMS906 suppresses mature CFD at or
below minimum detectable levels for 4 weeks
- Dose-dependent PK/PD profile across all cohorts is favorable
and supports low-dose, once-monthly or less frequent subcutaneous
dosing
The study is ongoing with additional single- and multiple-dose
cohorts to determine the pharmacologic dose range and optimal
frequency for subcutaneous administration.
“The data from the Phase 1 clinical trial to date confirm our
expectations for the role and dosing of OMS906 in humans,” said
Gregory A. Demopulos, M.D., chairman and chief executive officer of
Omeros. “The data validate, in humans, the function of MASP-3 – the
key activator of the alternative pathway – as a regulator of CFD
and support the potential of OMS906 as a safe and long-acting
therapeutic for the treatment of alternative pathway-related
diseases and disorders. Omeros has built a strong intellectual
property position around MASP-3 inhibition, and we look forward to
completing the current study and advancing to a Phase 2 clinical
trial as quickly as possible.”
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 activator of the
alternative pathway of complement (APC). APC inhibitors are thought
to have preventive or therapeutic effects across a broad range of
diseases including paroxysmal nocturnal hemoglobinuria, hemolytic
uremic syndrome (HUS), atypical HUS, traumatic brain injury,
arthritis, wet age-related macular degeneration,
ischemia-reperfusion injury, transplant-related complications and
other immune-related disorders. Omeros is developing both antibody
and small molecules to block MASP-3. Through its growing
intellectual property position, Omeros exclusively controls
inhibitors of the protein activator of the alternative pathway
(MASP-3) and, with its OMS721 program, inhibitors of the effector
enzyme of the lectin pathway (MASP-2), allowing the company to
target with unprecedented precision diseases caused by
dysregulation of one or both of these pathways.
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed
to discovering, developing and commercializing small-molecule and
protein therapeutics for large-market and orphan indications
targeting inflammation, immunologic diseases (e.g.,
complement-mediated diseases and cancers) and central nervous
system disorders. Its commercial product OMIDRIA® (phenylephrine
and ketorolac intraocular solution) 1%/0.3% continues to gain
market share in cataract surgery. Omeros’ lead MASP-2 inhibitor
narsoplimab targets the lectin pathway of complement and is the
subject of a biologics license application under priority review by
FDA for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy. Narsoplimab is
also in multiple late-stage clinical development programs focused
on other complement-mediated disorders, including IgA nephropathy,
atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’
inhibitor of MASP-3, the key activator of the alternative pathway
of complement, is in a Phase 1 clinical trial, and the company’s
PDE7 inhibitor program OMS527, targeting addiction and movement
disorders, has successfully completed a Phase 1 trial. Omeros’
pipeline holds a diverse group of preclinical programs including a
proprietary-asset-enabled antibody-generating technology and a
proprietary GPCR platform through which it controls 54 GPCR drug
targets and their corresponding compounds. One of these novel
targets, GPR174, modulates a new cancer immunity axis recently
discovered by Omeros, and the company is advancing GPR174-targeting
antibodies and small-molecule inhibitors. For more information
about Omeros and its programs, visit www.omeros.com.
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,” “objective,”
“plan,” “potential,” “predict,” “project,” “should,” “slate,”
“target,” “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 processes and oversight,
challenges associated with manufacture or supply of our
investigational products, intellectual property claims, competitive
developments, and the risks, uncertainties and other factors
described under the heading “Risk Factors” in the company’s Annual
Report on Form 10-K filed with the Securities and Exchange
Commission (SEC) on March 1, 2021. 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, whether as a result of
new information, future events or otherwise, except as required by
applicable law.
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Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations 360.668.3701 jennifer@cwcomm.org
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