Omeros Corporation (NASDAQ: OMER) today announced that data from
the dose-ranging stage of the Phase 2 clinical trial evaluating
OMS721 in the treatment of atypical hemolytic uremic syndrome
(aHUS) will be presented next month at the International Society of
Nephrology’s World Congress of Nephrology in Mexico City. The
poster presentation, “Dose-Finding Clinical Trial of OMS721 for the
Treatment of Atypical Hemolytic Uremic Syndrome (aHUS) – Stage 1
Results,” summarizes early clinical data from three different doses
of OMS721 administered for up to four weeks in patients with aHUS.
The poster (Number SAT-218) will be presented by Professor Michal
Nowicki, an OMS721 clinical trial investigator and President of the
Polish Society of Nephrology, during a moderated poster session
scheduled for Saturday, April 22nd, 12:00 - 13:15 PDT, Hall A
(Exhibition). 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.
Recently published on the International Society of Nephrology
website, an abstract of the poster summarizes the data to be
presented. The data are from Stage 1 of the open-label trial
evaluating the use of OMS721 in patients with thrombotic
microangiopathies, including aHUS, across multiple doses. To be
enrolled in the trial, patients with aHUS must either (1) have
demonstrated thrombocytopenia, evidence of microangiopathic
hemolytic anemia, and elevated creatinine despite at least four
plasma therapy (PT) treatments (PT-resistant patients); or (2) have
required at least weekly PT and had elevated creatinine
(PT-responsive patients). Patients received OMS721 in one of three
dosing groups (low, middle, high) by intravenous administration
weekly for up to four weeks. Patients in each cohort could receive
additional OMS721 half-doses after PT, if administered.
Seven patients with aHUS were enrolled in Stage 1: three
patients in the low-dose group, two patients in the mid-dose group
and two patients in the high-dose group. One patient in the
high-dose group was PT-responsive and the remaining six patients
were PT-resistant. The data demonstrate a dose response in platelet
count assessed as change from baseline. The mean change from
baseline in platelet count was statistically significant (p <
0.05) as measured by area under the curve (AUC). Renal replacement
therapy (RRT) was able to be discontinued in one patient during
OMS721 treatment and renal function remained stable following
completion of treatment. Another patient, who was on chronic RRT
and considered ineligible for kidney transplantation, stabilized on
OMS721 treatment and was deemed eligible for transplantation.
“These data demonstrate a clear dose response with significant
and clinically meaningful improvement in aHUS patients treated with
OMS721,” stated Professor Nowicki. “Not only was platelet count
increased with just four weeks of dosing in these patients, renal
failure was reversed and dialysis was able to be stopped. Assuming
that similar data are seen in the ongoing Phase 3 trial, OMS721
would represent an important and welcome treatment for patients
with aHUS.”
OMS721 was well tolerated in this trial. Five serious adverse
events (SAEs) were reported. A case of granulomatous orchitis in a
patient with a prior history of M. haemophilum infection was
considered by the investigator to be possibly a relapse and
treatment-related; all cultures were subsequently found to be
negative and the patient recovered. No other SAEs were considered
treatment-related.
“Our Phase 3 trial evaluating OMS721 in aHUS patients is
underway,” stated Gregory A. Demopulos, M.D., chairman and chief
executive officer of Omeros. “OMS721 has been shown to ablate
activity in the lectin pathway of complement, believed to be the
trigger for aHUS, and we expect that patients will find
subcutaneous dosing of OMS721 both convenient and comfortable. In
addition to our Phase 3 program in aHUS, we are planning to
initiate Phase 3 programs this year in IgA nephropathy and in stem
cell transplant-associated thrombotic microangiopathy, and the
breadth of potential indications for OMS721 continues to grow.”
About Omeros’ MASP ProgramsOmeros 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; 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 CorporationOmeros 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 StatementsThis 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170327005389/en/
Cook Williams Communications, Inc.Jennifer Cook WilliamsInvestor
and Media Relations360.668.3701jennifer@cwcomm.org
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