-- Additional Positive Results Support Rapid Advancement to Phase 3
Trial --
SEATTLE--(BUSINESS WIRE)--May 17, 2017--
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.
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Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360-668-3701
jennifer@cwcomm.org