--Additional Positive Data Reported from Second
Cohort in Phase 2 Trial--
Omeros Corporation (Nasdaq: OMER) today announced that it has
finalized its clinical plan for OMS721 submission and approval in
immunoglobulin A nephropathy (IgAN) following a recent meeting with
the U.S. Food and Drug Administration (FDA). OMS721 is Omeros’ lead
human monoclonal antibody targeting MASP-2, the effector enzyme of
the complement system’s lectin pathway. There is no approved
treatment for IgA nephropathy.
FDA Meeting UpdateClinical results from the first and
second cohorts of the Phase 2 trial in IgAN were part of
the background materials provided to FDA
for the recent meeting on the Phase 3 clinical
program. During the FDA meeting, the following points were
confirmed:
- The Phase 3 trial’s primary endpoint of
assessment of proteinuria was extended from 24 to 36 weeks at the
company’s request to allow for additional OMS721 dosing, if needed.
This continues to provide OMS721 a path to accelerated, or even
full, approval based on those 36-week proteinuria data in either
(i) the entire patient population (patients with baseline
proteinuria greater than 1 gm/24 hours) or (ii) the high-risk
subpopulation (those with baseline proteinuria of at least 2 gm/24
hours).
- Given investigators’ concerns about
extended withholding of OMS721 treatment from any high-risk study
patient initially randomized to the placebo-treated group, patients
in that subpopulation will be allowed open-label treatment with
OMS721 after at least 1 year of blinded treatment.
The OMS721 Phase 3 ARTEMIS-IGAN trial continues to enroll and
will incorporate the beneficial changes noted above without any
impact to study patients already enrolled. The trial is designed
based on the positive results from the two previously reported
Phase 2 cohorts – the first assessing patients who were receiving
corticosteroids at time of enrollment and then tapered off steroids
during the study and the second comprised of patients who were not
taking steroids.
Additional Phase 2 DataAdditional data are available from
patients in the second cohort of the Phase 2 trial who entered the
extended follow-up period, all receiving OMS721 treatment during
this period. The 8 patients in the extended follow-up period had
longstanding IgA nephropathy (median time from diagnosis of 11.6
years) with significant comorbidities and significantly impaired
renal function (median baseline estimated glomerular filtration
rate (eGFR) of 35.7 mL/min/1.73 m2) with highly elevated baseline
proteinuria levels (median of 3,786 mg/24 hours). The data, based
on the last observation point for each patient, confirm the
positive results seen earlier:
- eGFR measurements have remained stable,
consistent with preservation of renal function
- 61 percent median reduction in
proteinuria from baseline (across all 8 patients, assessed at 31
weeks to 54 weeks post-baseline)
- 5 of the 8 patients have achieved
greater than 50 percent proteinuria reductions (median reduction of
65 percent), with 2 of those 5 having received their last OMS721
administration 5 months earlier
- Across the first (4 patients) and
second cohorts, a total of 9 of 12 patients achieved greater than
50 percent reductions in proteinuria (median reduction of 65
percent)
- OMS721 continues to be well tolerated
and no safety concerns have been observed
“The data from the Phase 2 study continue to show a consistent
and significant drug effect, the magnitude of which is
unparalleled,” stated Richard Lafayette, MD, Professor of Medicine
(Nephrology) and Director of the Glomerular Disease Center,
Stanford University Medical Center and chair of the OMS721 IgAN
Academic Leadership Committee. “Nephrologists are focused on
long-term kidney survival, and the observed effects of OMS721 on
both proteinuria and eGFR are what we would hope to see in an IgAN
treatment. The OMS721 Academic Leadership Committee believes the
data on OMS721 in IgAN are sufficiently groundbreaking and robust
to warrant publication in a major scientific journal and plans to
submit the Phase 2 data for publication in the first half of this
year, together with other publications directed to OMS721 in renal
disease throughout 2019. From the perspective of the ALC, the
extended data from the Phase 2 cohort study strongly support the
potential efficacy of OMS721 in IgA nephropathy, even in patients
at the very highest risk of progression to kidney failure. The
data, together with the recently finalized registration plan, are
further consistent with our expectations that the OMS721 Phase 3
ARTEMIS-IGAN trial will be successful, and we look forward to
making the drug available to our patients.”
In addition to IgAN, OMS721 is in Phase 3 clinical programs for
hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA) and atypical hemolytic uremic syndrome.
OMS721 holds breakthrough therapy designations from FDA for IgAN
and for HSCT-TMA and, to the company’s knowledge, no other drug has
breakthrough therapy designation for either of these
indications.
“The additional understandings reached with FDA are important,
and we appreciate the Agency’s ongoing engagement around our
breakthrough designation for OMS721 in IgA nephropathy,” stated
Gregory A. Demopulos, MD, chairman and chief executive officer of
Omeros. “We’re confident in the effects seen with OMS721 and in our
registration approach for the drug in IgA nephropathy, and we
expect that it will likely follow stem-cell transplant TMA as the
second approved indication for OMS721.”
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. Gene-targeted MASP-2-deficient
mice and humans with MASP-2 gene polymorphisms that affect MASP-2
serum levels and MASP-2 functional activity are generally healthy
with no obvious adverse phenotype.
Phase 3 clinical programs are in progress for OMS721 in
hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA), in immunoglobulin A (IgA) nephropathy,
and in atypical hemolytic uremic syndrome (aHUS). Also, two Phase 2
trials are ongoing. One is continuing to enroll IgA nephropathy
patients and has already generated positive data in patients with
IgA nephropathy and with lupus nephritis; the other continues to
enroll patients with HSCT-TMA and has previously reported positive
data in patients with HSCT-TMA and in patients with aHUS. 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 and for HSCT-TMA, orphan drug
status for the prevention (inhibition) of complement-mediated
thrombotic microangiopathies, for the treatment of IgA nephropathy,
for the treatment of HSCT-TMA, and fast track designation for the
treatment of patients with aHUS. The European Medicines Agency has
granted orphan drug designation to OMS721 for treatment of primary
IgA nephropathy and for treatment in HSCT.
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 has initiated the manufacturing
scale-up process of its MASP-3 antibodies in preparation for
clinical trials.
About Omeros CorporationOmeros is a commercial-stage
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. The company’s drug product OMIDRIA® (phenylephrine and
ketorolac intraocular solution) 1% / 0.3% is marketed 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. In the
European Union, the European Commission has approved OMIDRIA for
use in cataract surgery and other IOL 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; cognitive impairment;
and addictive and compulsive disorders. In addition, Omeros has a
diverse group of preclinical programs and a proprietary G
protein-coupled receptor (GPCR) platform through which it 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 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,” “future”, “goal,” “intend,”
“likely”, “look forward to,” “may,” “on track”, “path”, “plan,”
“potential,” “predict,” “project,” “prospects,” “should,” “slated,”
“will,” “would” and similar expressions and variations thereof.
Forward-looking statements, including statements regarding the
anticipated basis and prospects for approval of OMS721, 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 November
8, 2018. 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: https://www.businesswire.com/news/home/20190117005229/en/
Jennifer Cook WilliamsCook Williams Communications, Inc.Investor
and Media Relations360.668.3701jennifer@cwcomm.org
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