– Sustained Proteinuria Reduction and GFR Improvement in up to
One-Year Follow-up Data –
SEATTLE--(BUSINESS WIRE)--Aug. 14, 2017--
Omeros Corporation (NASDAQ: OMER) today announced additional follow-up
data from patients with immunoglobulin A (IgA) nephropathy treated with
OMS721 in the Phase 2 clinical trial of glomerulonephropathy. OMS721 is
Omeros’ lead human monoclonal antibody targeting mannan-binding
lectin-associated serine protease-2 (MASP-2), the effector enzyme of the
lectin pathway of the complement system.
As presented in June 2017 at the 54th Congress of the
European Renal Association-European Dialysis and Transplant Association,
patients with IgA nephropathy demonstrated clinically and statistically
significant improvement in proteinuria during the course of the clinical
trial. After these patients completed the trial, the clinical
investigator continued to follow them per standard of care. Follow-up
data up to approximately one year after completion of treatment are
available.
As previously reported, all four IgA nephropathy patients in the
clinical trial demonstrated a substantial reduction in proteinuria
measured by both 24-hour urine protein excretion levels and urinary
albumin/creatinine ratios (uACRs). In post-trial follow-up, urine
protein/creatinine ratios (uPCR) were measured by the investigator
according to his practice standard. For purposes of post-hoc comparisons
of proteinuria during and after the clinical trial, each post-trial uPCR
value was converted to uACR (Zhao, Clin J Am Soc Nephrol 2016;11:947-55).
In follow-up, three of the four patients have maintained reductions in
proteinuria. In these three patients uACRs remained reduced at 14
percent, 23 percent, and 24 percent of the patients’ baseline values
prior to OMS721 treatment. In addition, a suggestion of improvement in
estimated glomerular filtration rate (eGFR), a measure of renal
function, was observed in 3 of the 4 patients after the trial. The
patient with the most severe reduction in kidney function demonstrated
eGFR improvement from 30 mL/min/1.73 m2 to 47 mL/min/1.73 m2,
an improvement of 57 percent. OMS721 was well-tolerated in the clinical
trial with fatigue and anemia the most commonly reported adverse events.
“The persistent reduction of proteinuria following completion of OMS721
treatment in these patients is impressive and provides additional
evidence of the important role of the lectin pathway in IgA
nephropathy,” stated Geoffrey Block, M.D., director of clinical research
at Denver Nephrology. “The improvements observed in eGFRs also suggest
that OMS721 could provide further benefit to patients by potentially
precluding or substantially extending the time to the need for dialysis
and reducing the risk of complications associated with progression of
chronic kidney disease.”
Omeros has initiated a Phase 3 clinical program for OMS721 in IgA
nephropathy and expects to begin a Phase 3 clinical trial in this
disease later this year. FDA has granted OMS721 both breakthrough and
orphan designations in IgA nephropathy.
“The durable reduction in proteinuria that we’re seeing with OMS721 for
one year after cessation of treatment is unprecedented in my
experience,” 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. “With this one-year follow-up, we are
also seeing improvement in eGFR, which usually takes significantly
longer to be evident. Two of the four patients demonstrated a slight
increase, with one of the patients showing an exciting response of 50
percent improvement.”
There is no approved treatment for IgA nephropathy, the most common
primary glomerulopathy globally. The disease is responsible for up to 10
percent of all dialysis patients. In the U.S. alone, an estimated
120,000 to 180,000 patients have this disease. Up to 40 percent of IgA
nephropathy patients develop end-stage renal disease, a life-threatening
condition, within 20 years following diagnosis.
“The sustained duration of effect of OMS721 post-treatment underscores
the drug’s potential for episodic dosing in IgA nephropathy,” said
Gregory A. Demopulos, M.D., chairman and chief executive officer of
Omeros. “We look forward to working with FDA to finalize the protocol
for our Phase 3 clinical trial and open enrollment to IgA nephropathy
patients later this year.”
In addition to its Phase 3 program in IgA nephropathy, OMS721 is also
being evaluated in a Phase 3 clinical program for atypical hemolytic
uremic syndrome and in a Phase 2 clinical program for hematopoietic stem
cell transplant-associated thrombotic microangiopathy.
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 clinical program for OMS721 in atypical hemolytic
uremic syndrome (aHUS) is in progress. A second Phase 3 clinical program
for OMS721 has been initiated in immunoglobulin A (IgA) nephropathy.
Also, two Phase 2 trials are ongoing. One is continuing to enroll OMS721
in IgA nephropathy following an earlier Phase 2 trial that generated
positive data in patients with IgA nephropathy and with lupus nephritis;
the other is enrolling and has reported positive data both in patients
with hematopoietic stem cell transplant-associated thrombotic
microangiopathy (TMA). A third Phase 3 program could begin later this
year in stem cell transplant-associated TMA. OMS721 can be administered
both intravenously and subcutaneously, and Omeros expects to
commercialize each formulation of OMS721 for different therapeutic
indications. In parallel, Omeros is 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 breakthrough
therapy designation for IgA nephropathy, orphan drug status for the
prevention (inhibition) of complement-mediated TMAs and for the
treatment of IgA nephropathy, and fast track designation for the
treatment of patients with aHUS.
Omeros also has identified MASP-3 as responsible for the conversion of
pro-factor D to factor D and as a critical activator of the human
complement system’s alternative pathway. The alternative pathway 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. Omeros is preparing to initiate
manufacturing scale-up of its MASP-3 antibodies in advance of clinical
trials.
About Omeros Corporation
Omeros is a biopharmaceutical company committed to discovering,
developing and commercializing small-molecule and protein therapeutics
for large-market as well as orphan indications targeting inflammation,
complement-mediated diseases 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 multiple Phase 3 and Phase 2 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 and controls 54 new GPCR drug targets and corresponding
compounds, a number of which are in preclinical development. The company
also exclusively possesses a novel antibody-generating platform.
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 August 8, 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/20170814005808/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Investor and Media Relations
Jennifer
Cook Williams, 360-668-3701
jennifer@cwcomm.org
