-- Additional Positive Results Support Rapid
Advancement to Phase 3 Trial --
Omeros Corporation (NASDAQ: OMER) today announced completion of
the IgA nephropathy cohort and reported additional positive results
from the first stage of the company’s Phase 2 clinical trial of
OMS721 for the treatment of serious kidney disorders. All patients
in the cohort have now completed the OMS721 treatment and follow-up
periods. The additional Phase 2 results in IgA nephropathy patients
expand on the data reported earlier this year and further
demonstrate marked and statistically significant improvement in
urine protein levels (proteinuria). Proteinuria reduction is
associated with slowing progression of kidney functional loss, and
greater proteinuria reductions are associated with progressively
better prognoses. OMS721 is Omeros’ lead human monoclonal antibody
targeting mannan-binding lectin-associated serine protease-2
(MASP-2), the effector enzyme of the complement system’s lectin
pathway.
“I have never seen the clinical responses that I’ve observed in
IgA nephropathy patients treated with OMS721,” stated Geoffrey
Block, M.D., Director of Clinical Research at Denver Nephrology and
Principal Investigator of the trial. “All of these patients had
significant renal impairment when they entered the trial and each
patient dramatically improved. The improvements in these patients
continued to increase after the end of treatment and persisted
following completion of the trial. As an active clinical
investigator, given the strength of these data, I am working hard
to move this promising drug through the clinical trial
process.”
The first stage in this Phase 2 trial includes four different
types of complement-associated kidney diseases: IgA nephropathy,
membranous nephropathy, lupus nephritis, and complement component 3
(C3) glomerulopathy. All patients had pre-existing renal
impairment. To meet enrollment criteria, patients must have high
levels of proteinuria despite well-controlled blood pressure with
stable dosing of renin-angiotensin system inhibitors and ongoing
(at least three months) corticosteroid treatment prior to receiving
OMS721. Patients in this cohort are treated open-label with OMS721
for a total of 12 weeks and then followed post-treatment for six
weeks. The trial endpoints are measured throughout the treatment
and follow-up periods and assess the effect of OMS721 on urine
protein measures that are predictive of kidney failure, namely
urine albumin-to-creatinine ratio (uACR) and total 24-hour urine
protein excretion.
All IgA nephropathy patients had Stage 3B chronic kidney disease
and three of the four patients had nephrotic range proteinuria. All
patients demonstrated marked improvement in uACRs and in 24-hour
urine protein excretion while concurrently tapering corticosteroid
treatment. The mean baseline uACR in these patients was 1,457 mg/g
and reached 332 mg/g at the end of the follow-up period (77 percent
decrease; p = 0.026). One patient’s uACR normalized by the National
Kidney Foundation criterion. Results of 24-hour urine protein
excretion were highly consistent with the uACR results, with a
reduction from a mean of 3,935 mg/day at baseline to a mean of
1,067 mg/day at the end of the follow-up period (73 percent
decrease; p = 0.013). All patients achieved partial remission based
on proteinuria and one patient with nephrotic range proteinuria
achieved a 95 percent reduction, reaching reference
laboratory-established normal urine protein levels. All patients
also were able to eliminate or greatly reduce their corticosteroid
dosing.
“The OMS721 results in patients with IgA nephropathy continue to
be striking,” said Jonathan Barratt, Ph.D., F.R.C.P., Professor of
Renal Medicine in the Department of Infection, Immunity &
Inflammation at University of Leicester and Honorary Consultant
Nephrologist at Leicester General Hospital. “The degree of
improvement observed with OMS721 is the largest I have seen and I
expect will result in significant improvement in renal
outcomes.”
Consistent with all other OMS721 clinical trials, no significant
safety concerns have been observed. The most commonly reported
adverse events in this trial are fatigue and anemia.
“We are pleased with the continued consistency of the results
seen in these patients treated with OMS721,” stated Gregory A.
Demopulos, M.D., chairman and chief executive officer of Omeros.
“Despite being an orphan disease, IgA nephropathy is the most
common primary glomerular disease worldwide, and we are keenly
focused on this indication for OMS721. We are aggressively
advancing to our Phase 3 clinical trial and look forward to
beginning patient enrollment as soon as possible.”
No treatments are approved for IgA nephropathy. With an annual
incidence of approximately 1 per 100,000, it is estimated that 1 in
1,400 persons in the U.S. will develop IgA nephropathy in his or
her lifetime. As many as 40 percent of them will develop end-stage
renal disease.
While preparing for its Phase 3 clinical trial in IgA
nephropathy, Omeros is continuing to conduct the second stage of
its ongoing Phase 2 clinical trial in which OMS721 is evaluated in
non-steroid-treated patients with IgA nephropathy. As previously
reported, 4 of 5 lupus nephritis patients in the Phase 2 trial also
demonstrated marked reduction in 24-hour urine protein levels (mean
reduction of 69 percent) with OMS721 treatment. Further analyses
are in progress.
About Omeros’ MASP Programs
Omeros controls the worldwide rights to MASP-2 and all
therapeutics targeting MASP-2, a novel pro-inflammatory protein
target involved in activation of the complement system, which is an
important component of the immune system. The complement system
plays a role in the inflammatory response and becomes activated as
a result of tissue damage or microbial infection. MASP-2 is the
effector enzyme of the lectin pathway, one of the principal
complement activation pathways. 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, and its abnormal function is
associated with a wide range of autoimmune disorders. MASP-2 is
generated by the liver and is then released into circulation. Adult
humans who are genetically deficient in one of the proteins that
activate MASP-2 do not appear to be detrimentally affected by the
deficiency. OMS721 is Omeros’ lead human MASP-2 antibody. Following
discussions with both the FDA and the European Medicines Agency, a
Phase 3 program for OMS721 in atypical hemolytic uremic syndrome
(aHUS) is in progress. Also, two Phase 2 trials are ongoing. One is
evaluating OMS721 in glomerulonephropathies, which has generated
positive data in patients with immunoglobulin A (IgA) nephropathy
and with lupus nephritis; the other has reported positive data both
in patients with hematopoietic stem cell transplant-associated
thrombotic microangiopathy (TMA) and in those with aHUS. In
addition to potential intravenous administration, Omeros plans to
commercialize OMS721 for one or more therapeutic indications as a
subcutaneous injection and is also developing small-molecule
inhibitors of MASP-2. Based on requests from treating physicians,
Omeros has established a compassionate-use program for OMS721,
which is active in both the U.S. and Europe. The FDA has granted
OMS721 both orphan drug status for the prevention (inhibition) of
complement-mediated TMAs and fast track designation for the
treatment of patients with aHUS.
Omeros also has identified MASP-3 as the critical activator of
the human complement system’s alternative pathway, which is linked
to a wide range of immune-related disorders. In addition to its
lectin pathway inhibitors, the company is advancing its development
of antibodies and small-molecule inhibitors against MASP-3 to block
activation of the alternative pathway.
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 May 10,
2017. 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170517005459/en/
Cook Williams Communications, Inc.Jennifer Cook WilliamsInvestor
and Media Relations360-668-3701jennifer@cwcomm.org
Omeros (NASDAQ:OMER)
Historical Stock Chart
From Apr 2024 to May 2024
Omeros (NASDAQ:OMER)
Historical Stock Chart
From May 2023 to May 2024