-- First Report of Narsoplimab’s Effects on
Complement Activation Markers in Renal Disease Presented at the
Annual Meeting of the American Society of Nephrology --
Omeros Corporation (Nasdaq: OMER) today
announced that the first report describing the effects of
lectin-pathway inhibition by narsoplimab on urinary complement
levels in kidney disease was presented yesterday at the Annual
Meeting of the American Society of Nephrology (ASN). The work,
conducted by a consortium from Denmark and the United Kingdom and
led by Peter Garred, MD, DMSc, Chair and Professor of Clinical
Molecular Medicine at the University of Copenhagen, was detailed at
the ASN Annual Meeting in a poster entitled “Reduction of Urinary
Levels of Lectin Pathway Complement Components in an IgA Vasculitis
Patient after MASP-2 Inhibition with Narsoplimab”.
The patient, a 21-year-old woman, presented with a rapidly
progressive glomerulonephritis. The objective was to stabilize her
rapidly deteriorating kidney function to allow for renal
transplantation. Her clinical course and response to the MASP-2
inhibitor narsoplimab are detailed in a publication by Selvaskandan
et al.1 In brief, kidney biopsy revealed marked vascular damage
with significant interstitial fibrosis, tubular atrophy and
evidence of complement involvement. Diagnosed with IgA vasculitis,
she developed rapidly worsening kidney function with highly
elevated creatinine levels, hypertension, proteinuria, and
hematuria despite treatment with systemic corticosteroids. She
began treatment with narsoplimab. After one course of 12 weekly
doses of narsoplimab, her kidney function stabilized and she was
able to undergo successful renal transplantation without the need
for dialysis.
As reported in yesterday’s ASN Annual Meeting presentation,
complement levels assessed in urinary samples collected during the
patient’s clinical course demonstrated substantial reduction in
local complement activation associated with narsoplimab
treatment-related lectin-pathway inhibition and stabilization of
kidney function. Specifically, C4c/creatinine ratio,
ficolin-3/creatinine ratio and C3bc/creatinine ratio levels were
decreased 75%, 58% and 29%, respectively, from baseline to the end
of the treatment. Levels of MBL and CL-11 remained stable during
treatment. Further studies are ongoing to evaluate the use of urine
as a non-invasive and readily accessible resource to monitor
responses to narsoplimab treatment.
A second presentation directed to narsoplimab in IgA-related
disease – Long-Term Phase 2 Efficacy of the MASP-2 Inhibitor
Narsoplimab for Treatment of Severe IgA Nephropathy – was also
included in yesterday’s program at the ASN Annual Meeting.
1Selvaskandan H, Kay Cheung C, Dormer J, Wimbury D, Martinez M,
Xu G, Barratt J. Inhibition of the lectin pathway of the complement
system as a novel approach in the management of IgA
vasculitis-associated nephritis. Nephron. 2020;144(9):453-458. doi:
10.1159/000508841.
About Narsoplimab
Narsoplimab, also known as “OMS721,” is an investigational human
monoclonal antibody targeting mannan-binding lectin-associated
serine protease-2 (MASP-2), a novel pro-inflammatory protein target
and the effector enzyme of the lectin pathway of complement.
Importantly, inhibition of MASP-2 does not appear to interfere with
the antibody-dependent classical complement activation pathway,
which is a critical component of the acquired immune response to
infection. Omeros controls the worldwide rights to MASP-2 and all
therapeutics targeting MASP-2.
A biologics license application (BLA) is pending before the U.S.
FDA for use of narsoplimab in the treatment of HSCT-TMA, and the
drug is in Phase 3 clinical programs for immunoglobulin A (IgA)
nephropathy and atypical hemolytic uremic syndrome (aHUS).
Narsoplimab is also being evaluated for the treatment of COVID-19
as part of the I-SPY-COVID-19 platform trial sponsored by Quantum
Leap Healthcare Collaborative. FDA has granted narsoplimab
breakthrough therapy designations for HSCT-TMA and for IgA
nephropathy; orphan drug status for the prevention (inhibition) of
complement-mediated thrombotic microangiopathies, for the treatment
of HSCT-TMA and for the treatment of IgA nephropathy; and fast
track designation for the treatment of patients with aHUS. The
European Medicines Agency has granted orphan drug designation to
narsoplimab for treatment in HSCT and for treatment of primary IgA
nephropathy.
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 pending before 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, including statements regarding
Omeros’ research and development programs and the therapeutic
application of research findings, 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, the impact of COVID-19 on our business, regulatory
processes and oversight, challenges associated with manufacture or
supply of our investigational or commercial products, delays in
completion of ongoing or planned clinical trials, competitive
developments, litigation, 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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version on businesswire.com: https://www.businesswire.com/news/home/20211105005405/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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