At lowest planned subcutaneous dose, Omeros’ MASP-3 inhibitor
OMS906 showed clinically and statistically significant improvements
in hemoglobin and LDH, which were seen early and maintained
throughout the observation period
- Following 2 doses of OMS906, all patients achieved an increase
in hemoglobin of ³ 4.0 g/dL, with a mean hemoglobin change from
baseline of 4.75 g/dL (p < 0.001)
- Following 3 doses of OMS906, mean hemoglobin increase from
baseline was 6.27 g/dL (p = 0.005)
- All OMS906-treated patients remained transfusion-free
throughout the observation period
- OMS906 was well tolerated with no safety signals of
concern
Omeros Corporation (Nasdaq: OMER) today announced positive
results from a pre-specified interim analysis of its ongoing Phase
1b clinical trial of OMS906, the company’s lead MASP-3 inhibitor,
in complement-inhibitor-naïve adults with paroxysmal nocturnal
hemoglobinuria (PNH), a rare and life-threatening hemolytic blood
disorder. Statistically significant and clinically meaningful
improvements were observed in all measured markers of hemolysis,
including hemoglobin (Hgb) and lactate dehydrogenase (LDH). To
date, all patients have received only the lowest subcutaneous dose
of OMS906 in this multidose trial.
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Figure 1: Mean Hemoglobin Change from
Baseline Over Time (Graphic: Business Wire)
The baseline mean Hgb was 6.78 g/dL. By Day 57 (after 2 doses),
all OMS906-treated patients achieved an increase in Hgb of 4.0 g/dL
or more, with a mean change from baseline of 4.75 g/dL (p <
0.001). By Day 85 (following 3 doses), the mean Hgb was 12.4 g/dL
with a mean change from baseline of 6.27 g/dL (p = 0.005).
Improvement was rapid, with significant mean Hgb improvement of
0.88 g/dL (p = 0.003) seen at the first timepoint (Day 8),
persistently increasing and remaining statistically significant
through the last observed timepoint (Day 85). No patients required
or received blood transfusions following OMS906 treatment
initiation. Figure 1 demonstrates the Hgb improvement.
The mean baseline LDH was 1931, nearly 8 times the upper limit
of normal. Statistically significant improvements in LDH were
observed at Day 8, the first measured timepoint, with subsequent
further and statistically significant reductions seen throughout
the observation period.
OMS906 has been safe and well tolerated in this trial,
consistent with Phase 1 safety observations in healthy
subjects.
This single-arm, open-label clinical trial is evaluating the
effect of once-monthly subcutaneous administration of OMS906 in
patients with PNH. A total of 9 patients have been enrolled to date
and all have been complement-inhibitor-treatment naïve. Co-existing
conditions in these 9 patients include aplastic anemia, iron
deficiency, myelodysplastic syndrome, and chronic renal failure. To
date, 7 patients have received 2 or more doses of OMS906, 4 have
received 3 or more doses, and 3 have received 4 doses.
Omeros has established a broad intellectual property estate
directed to the inhibition of MASP-3. OMS906 is Omeros’ lead
investigational humanized monoclonal antibody targeting MASP-3, the
key and most upstream activator of the alternative pathway of
complement. MASP-3 circulates in low concentrations and has slow
turnover, allowing consistent and long-duration target coverage and
pathway inhibition. Unlike other alternative and terminal
complement pathway inhibitors on the market or in development,
MASP-3 inhibition leaves the infection-fighting function of the
classical pathway intact and, given that MASP-3 is known not to be
an acute phase reactant, has less risk of breakthrough occurrence
of the underlying disease. Inhibition of MASP-3, which is located
upstream of complement component 5 (C5), C3, Factor B and Factor D,
is expected to block both intra- and extravascular hemolysis in
PNH.
Based on pharmacokinetic data in both healthy subjects and
patients with PNH and the efficacy data observed in PNH patients,
Omeros is targeting a dosing frequency of once quarterly either
intravenously or subcutaneously. This dosing frequency and the
extended OMS906 half-life should provide excellent patient
convenience and compliance as well as additional protection from
pharmacokinetic or pharmacodynamic breakthrough, further enhancing
efficacy.
“These trial data are quite impressive,” said Eleni Gavriilaki,
M.D., Ph.D., assistant professor of hematology at Aristotle
University, Thessaloniki, Greece. “The effect of OMS906 in PNH, a
disease that requires a high level of alternative pathway
suppression to see clinical benefit, bodes well for the drug’s role
in treating any disorder associated with dysregulation of the
pathway. Achievement of once-quarterly dosing would be well
received by physicians and their patients, representing a paradigm
shift in the treatment of PNH and other alternative pathway
disorders.”
Omeros’ second OMS906 clinical trial in PNH patients, treating
those who have demonstrated an inadequate response to ravulizumab,
a C5 inhibitor, just recently entered the OMS906 dosing phase and
is ongoing. The OMS906 clinical trial in C3 glomerulopathy is also
underway. Preliminary data from both of these trials are expected
in the third quarter of this year. Omeros is also preparing to
initiate a clinical trial assessing once-quarterly systemic
delivery of OMS906, avoiding the need for intravitreal delivery, in
patients with geographic atrophy, an advanced form of dry
age-related macular degeneration (AMD).
“We are excited by the data resulting from this trial of
treatment-naïve patients,” said Gregory A. Demopulos, M.D., Omeros’
chairman and chief executive officer. “The degree of hemoglobin
improvement in such a severely anemic population is remarkable. The
results observed to date demonstrate that OMS906 provides
clinically effective inhibition of the alternative pathway, opening
for the drug the wide range of alternative pathway-related
diseases, a good number of which already have been clinically
validated by agents on the market or in development. We believe
that the strong proof-of-concept data generated, the scope of
already-validated alternative pathway-related diseases, and the
expected advantages of OMS906 over other alternative pathway
inhibitors make clear the drug’s substantial commercial
potential.”
Omeros will present detailed clinical trial data, including data
in this preliminary analysis, at an upcoming international
conference. Omeros is also amending both of its ongoing Phase 1b
clinical trials in PNH to Phase 2, expanding enrollment, assessing
planned higher doses, and making preparations to meet with
regulatory authorities to discuss the clinical development plan to
approval.
About Omeros Corporation
Omeros is an innovative biopharmaceutical company committed to
discovering, developing and commercializing small-molecule and
protein therapeutics for large-market and orphan indications
targeting immunologic disorders including complement-mediated
diseases, cancers, and addictive and compulsive disorders. Omeros’
lead MASP-2 inhibitor narsoplimab targets the lectin pathway of
complement and is the subject of a biologics license application
pending before FDA for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy (TA-TMA).
Narsoplimab is also in multiple late-stage clinical development
programs focused on other complement-mediated disorders, including
IgA nephropathy, COVID-19, and atypical hemolytic uremic syndrome.
Omeros’ long-acting MASP-2 inhibitor OMS1029 is currently in a
Phase 1 clinical trial. OMS906, Omeros’ inhibitor of MASP-3, the
key activator of the alternative pathway of complement, is
advancing in clinical programs for paroxysmal nocturnal
hemoglobinuria (PNH), complement 3 (C3) glomerulopathy and other
related indications. For more information about Omeros and its
programs, visit www.omeros.com.
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,” “likely,” “look forward to,” “may,” “objective,”
“plan,” “potential,” “predict,” “project,” “should,” “slate,”
“target,” “will,” “would” and similar expressions and variations
thereof. Forward-looking statements, including statements regarding
anticipated safety and therapeutic benefits of Omeros’ drug
candidates 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, unanticipated or unexpected
difficulties in the conduct of planned research, unproven
preclinical and clinical development activities, changes in our
financial condition and results of operations, challenges
associated with manufacture or supply of our investigational drug
candidates, 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 13, 2023. 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, whether as a result of
new information, future events or otherwise, except as required by
applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230425005573/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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