SEATTLE, Wash.--(BUSINESS WIRE)--Mar. 27, 2017--
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 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; 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/20170327005389/en/
Source: Omeros Corporation
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org
