-- Data Show Improvement and Stabilization in
Renal Function --
- Unprecedented median proteinuria reduction of 64.4 percent seen
in the narsoplimab Phase 2 clinical trial predicts a 41.6-year
delay in need for dialysis compared to standard of care
- Narsoplimab is the first candidate targeting IgA nephropathy to
demonstrate long-term improvement or sustained stabilization in
eGFR
- 58 percent of patients received only one narsoplimab treatment
course (12 weekly doses) or less annually, with 25 percent of
patients showing improvement in eGFR despite having significant,
longstanding IgA nephropathy with high-risk comorbidities
- Narsoplimab-treated patients showed response irrespective of
stage of their advanced disease state
- Narsoplimab was well tolerated with no treatment-related
serious adverse events
- Long-term data from the narsoplimab Phase 2 clinical trial were
presented yesterday at the Annual Meeting of the American Society
of Nephrology by Richard Lafayette, M.D., Stanford University
Professor of Medicine-Nephrology and Director of the Stanford
Glomerular Disease Center
Omeros Corporation (Nasdaq: OMER) today announced results of
long-term follow-up from the Phase 2 clinical trial evaluating its
MASP-2 inhibitor narsoplimab in patients with IgA nephropathy.
Treatment with narsoplimab in this trial was associated with an
unprecedented median reduction in proteinuria of 64.4 percent. Now,
long-term follow-up (out to 35 months) of these patients shows a
markedly slowed rate of decline of estimated glomerular filtration
rate (eGFR). Using the same analytical approach adopted by other
companies* to determine the impact of proteinuria reduction on
long-term risk of need for dialysis, a 64.4 percent reduction in
proteinuria is predicted to delay progression to renal dialysis by
41.6 years compared to standard of care. While other companies have
reported up to 1-year follow-up data on eGFR, this is the first
time that sustained stabilization, let alone improvement, of eGFR
through long-term follow-up has been reported for any novel
therapeutic in development for IgA nephropathy. ARTEMIS-IGAN, the
Phase 3 clinical trial of narsoplimab in IgA nephropathy, is
ongoing.
“The long-term data are highly supportive of a key role for
lectin pathway inhibition in the future management of patients with
IgAN, and I am very much looking forward to seeing the results of
the ongoing ARTEMIS-IGAN Phase 3 clinical trial,” said Jonathan
Barratt, PhD, FRCP, the Mayer Professor of Renal Medicine at the
University of Leicester and Honorary Consultant Nephrologist at
Leicester General Hospital. “Most striking about these data is that
the responses seen in patients with advanced kidney failure and
severe proteinuria who had IgAN for over a decade are similar to
those patients with early, less advanced disease, and this I
believe speaks to the ability of narsoplimab to inhibit lectin
pathway activation in different segments of the nephron. In early
disease, glomerular complement activation predominates while, in
more established disease, it is lectin pathway activation in the
tubulointerstitial compartment, mediated through collectin-11, that
drives disease progression. Narsoplimab appears to be effective at
targeting both of these pathogenic pathways, which has implications
for the treatment of not just IgAN but of any proteinuric kidney
disease. Narsoplimab has shown a substantially greater reduction in
proteinuria – and a substantially longer projected delay to need
for dialysis – than any other drug in development for the treatment
of renal disease.”
The Phase 2 clinical trial (NCT02682407) consisted of two
sequential studies. Substudy 1 was a single-arm, open-label design
with 12 weekly intravenous (IV) infusions of narsoplimab in
patients who, at time of enrollment, were on corticosteroids that
were tapered during the study; the four IgA nephropathy patients
from substudy 1 were able to enter a dosing extension period. In
substudy 2, which included nine evaluable patients,
corticosteroid-free patients were randomized 1:1 to receive
once-weekly IV narsoplimab or vehicle infusions for 12 weeks, after
which they could continue in an open-label extension at the
investigator’s discretion. A total of 12 patients (four from
substudy 1 and eight from substudy 2) participated in the dosing
extension phase. These 12 patients were followed for up to nearly
three years (median 22 months), with the last assessment at 19
months or later for 75 percent of the study patients and at two
years or later for 50 percent of them.
The narsoplimab trial population consisted of high-risk patients
with advanced IgA nephropathy at study baseline with a median
disease duration of 6.9 years (range 0.4 – 27.5). Several other
risk factors, such as hypertension (83%) and obesity (58%; median
body mass index 32.5 kg/m2, range 24.4 – 44.3) were present in a
large majority of the cases along with excessive baseline
proteinuria (median urine protein excretion [UPE] of 4.2 g/24
hours; range 1.5 – 11.9) and renal failure (baseline median eGFR of
40.7 mL/min/1.73m2; range 25.4 – 75.9).
Narsoplimab appeared effective irrespective of the stage of the
study patients’ advanced disease state and, using the same
analytical approach adopted by other companies*, is predicted to
provide an unprecedented delay in progression to renal
dialysis.
- A median reduction in proteinuria of 64.4 percent was
previously observed across the 2 substudies in the narsoplimab
Phase 2 trial.
- The magnitude of median proteinuria reduction seen with
narsoplimab is predicted to delay progression to renal dialysis by
41.6 years compared to standard of care.
Through the nearly three-year extended follow-up:
- Study patients received a median of one course of 12 weekly
doses of narsoplimab per year (range 0.7 to 2.5 courses), with 58
percent of patients receiving one course or less per year.
- eGFR rate of decline was slowed by 3.4 mL/min/year compared to
a literature control cohort with IgA nephropathy** matched for
proteinuria excretion and eGFR levels.
- eGFR showed improvement in 25 percent of the patients despite
having significant IgA nephropathy with sclerotic lesions present
in the glomeruli and with significant risk factors such as
longstanding disease up to 18 years, obesity with BMI up to
38.1kg/m2, and long history of hypertension.
- Narsoplimab was well tolerated with no treatment-related
serious adverse events.
“The long-term data from the Phase 2 clinical trial in IgA
nephropathy confirm the previously published interim analysis
results and provide an excellent foundation for our ongoing Phase 3
clinical trial in IgA nephropathy ARTEMIS-IGAN,” said Gregory A.
Demopulos, M.D., chairman and chief executive officer of Omeros.
“MASP-2 inhibition with narsoplimab is associated with significant
proteinuria reduction and, most importantly, improvement and
stabilization of eGFR, even in high-risk patients with advanced IgA
nephropathy. We look forward to reading out the results from our
ongoing Phase 3 clinical trial.”
Long-term data from the narsoplimab Phase 2 clinical trial were
presented yesterday at the Annual Meeting of the American Society
of Nephrology (ASN) by Richard Lafayette, M.D., Stanford University
Professor of Medicine-Nephrology and Director of the Stanford
Glomerular Disease Center. The data are also being prepared for
submission to a peer-reviewed journal.
A second presentation directed to the benefits of narsoplimab in
IgA-related disease – Reduction of Urinary Levels of Lectin Pathway
Complement Components in an IgA Vasculitis Patient after MASP-2
Inhibition with Narsoplimab – was also part of yesterday’s program
at the ASN Annual Meeting.
___________________ *Carroll K. et al., Estimating Delay in Time
to ESKD for Treatment Effects on Proteinuria in IgA Nephropathy and
FSGS. ERA-EDTA 2021, Oral Presentation; and Calliditas Therapeutics
AB, April 2019, Investor Day Webinar. **Leicester Renal Unit IgA
Nephropathy Registry
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 Omeros’ 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/20211105005398/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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