-- Phase 3 Program Slated for This Year --
SEATTLE--(BUSINESS WIRE)--Mar. 30, 2017--
Omeros Corporation (NASDAQ: OMER) today announced additional positive
data from the company’s Phase 2 clinical trial of OMS721 for the
treatment of serious kidney disorders, which frequently lead to
end-stage renal disease and dialysis. 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. The clinical trial data include results from additional
study patients treated with OMS721 as well as longer-term follow-up on
earlier enrolled patients. The new data corroborate and expand on trial
results reported in the fourth quarter of 2016. Based on the uniformly
positive data in the fully enrolled cohort of OMS721-treated patients
with immunoglobulin A nephropathy (IgAN), Omeros recently met with the
FDA to discuss the Phase 3 development program.
“The clinical responses in my IgA nephropathy patients treated with
OMS721 are truly impressive,” stated Geoffrey Block, M.D., Director of
Clinical Research at Denver Nephrology. “These are patients with
significant renal impairment who had not responded to steroid therapy.
Each OMS721-treated patient substantially improved while markedly
reducing or stopping steroid use. Equally impressive is that, after
OMS721 treatment was completed, a legacy effect of continued improvement
was observed in each patient. I look forward to participating in the
Phase 3 clinical trial and to working with Omeros to make this important
drug broadly available to patients.”
The Phase 2 open-label trial is evaluating OMS721 across four different
types of complement-associated kidney diseases: IgAN, membranous
nephropathy, lupus nephritis, and complement component 3 (C3)
glomerulopathy. To meet enrollment criteria, patients must have high
levels of urinary protein (a marker used by nephrologists to assess
disease activity) despite well-controlled blood pressure with stable
dosing of renin-angiotensin system inhibitors and ongoing treatment with
a corticosteroid, thereby ensuring that study patients are unlikely to
improve spontaneously. Patients are treated with OMS721 for a total of
12 weeks: four weeks maintaining their entry corticosteroid dose; four
weeks of corticosteroid tapering, if tolerated; and four weeks of
resultant corticosteroid dose maintenance. Patients are then followed
post-treatment for six weeks.
The trial assesses the effect of OMS721 on urine protein measures that
are predictive of kidney failure, namely urine albumin/creatinine ratio
(uACR) and total 24-hour urine protein excretion, and on the ability to
reduce steroid dosing. Data were analyzed for the pre-specified IgAN
cohort of four patients (three have completed treatment in the study and
the fourth is finishing treatment).
Treatment effects across all IgAN patients were highly consistent, the
magnitude of which are associated with improved renal survival. Notably,
uACR values continued to improve after dosing was completed. In the
three patients who completed treatment, the mean baseline uACR was 1,400
mg/g and reached 671 mg/g at the end of treatment (52 percent decrease;
p = 0.02), continuing to decrease to 380 mg/g by the end of the
follow-up period. Measures of 24-hour urine protein excretion tracked
uACRs, with a mean reduction from 3,728 mg/day to 1,340 mg/day (64
percent decrease; p = 0.02). To date, after eight weeks of treatment,
the fourth patient’s uACR dropped from 1,628 mg/g to 733 mg/g, a
decrease of 55 percent. Partial remission is defined as greater than 50
percent reduction in 24-hour urine protein excretion. In the patients
who completed treatment, 24-hour urine protein levels decreased by
approximately 50 to 80 percent. Concurrently, daily steroid doses for
all patients were substantially reduced or completely eliminated.
“The OMS721 data in IgAN patients demonstrate a strength and rapidity of
clinical response that I have not seen with other agents in
development,” 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. “There currently is no approved therapy
for IgA nephropathy. The mechanism of IgA nephropathy – and proteinuria
in general – has been closely linked to the lectin pathway of
complement, and OMS721 directly targets the pathway’s effector enzyme
MASP-2. This could uniquely position OMS721 not only for the treatment
of IgA nephropathy but for a host of other kidney disorders as well.”
Encouraging results have also been observed in lupus nephritis. Four of
five patients showed a substantial (mean of 69 percent) reduction in
24-hour urine protein excretion over the treatment period. The fifth
patient experienced a systemic disease flare and showed a substantial
increase. The majority of lupus responders were able to taper their
steroid doses. Three patients with membranous nephropathy, a disease
with inherent variability, have completed treatment with mixed results.
Additional analyses are continuing in these patient groups.
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.
Omeros met with FDA recently to discuss these data and Phase 3
development. Following review of the data, FDA suggested that Omeros
apply for breakthrough therapy designation in IgAN. The discussion
included accelerated approval and an expedited approach to full approval
based on an endpoint of proteinuria, which could be faster than
accelerated approval. Omeros is preparing its breakthrough application
and a Phase 3 protocol for discussion with FDA. The Phase 3 trial in
IgAN is expected to begin this year.
“We’re pleased with the consistently positive data seen in IgAN
patients, further expanding the strong OMS721 clinical results beyond
those previously reported in aHUS and stem-cell transplant patients,”
stated Gregory A. Demopulos, M.D., chairman and chief executive officer
of Omeros. “We are submitting our breakthrough therapy application to
FDA and look forward to working closely with U.S. and international
regulators as we advance through our Phase 3 clinical programs across
multiple indications for OMS721.”
No treatments are approved for IgAN, an orphan disease but the most
common primary glomerular disease globally. 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 IgAN in his or her lifetime. As many as 40 percent
of them will develop end-stage renal disease.
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 Annual Report on Form
10-K filed with the Securities and Exchange Commission on March 16,
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/20170330005487/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org
