Omeros Announces Preliminary Results from Additional Critically Ill COVID-19 Patients Treated with Narsoplimab
May 28 2021 - 7:45AM
Business Wire
-- Study Patients Comprise Second Cohort from
Bergamo, Italy --
Omeros Corporation (Nasdaq: OMER), 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,
immunologic diseases (e.g., complement-mediated diseases and
cancers) and central nervous system disorders, today announced
preliminary results from the second cohort of critically ill
COVID-19 patients treated with narsoplimab in Bergamo, Italy. These
patients were part of the “second surge” of COVID-19 in Italy.
Narsoplimab is the company’s lead inhibitor of mannan-binding
lectin-associated serine protease 2 (MASP-2), the effector enzyme
of the lectin pathway of complement.
“The COVID-19 patients in this group were even sicker than those
in the first cohort of patients treated with narsoplimab at our
institution during the pandemic’s outbreak,” said Alessandro
Rambaldi, MD, Professor, Department of Oncology and
Hematology-Oncology at the University of Milan and Head of the
Hematology and Bone Marrow Transplant Unit at ASST Papa Giovanni
XXIII in Bergamo, Italy. “All of the patients had significant ARDS
with 90 percent of them intubated at the start of narsoplimab
treatment, the majority had multiple comorbidities and risk factors
for poor outcome, and all had failed other therapies. The results
in these patients are outstanding and further support what we have
learned about the pathophysiology of COVID-19, the central role of
endothelial damage in the disease, and the mechanism of action of
narsoplimab.”
The patients were treated under compassionate use at ASST Papa
Giovanni XXIII Hospital between October 2020 and April 2021.
Highlights of the study are as follows:
Baseline characteristics of the 10 study patients
- Median age: 65 years (range 41 to 79 years)
- 90% were men
- All had comorbidities/risk factors for poor outcome (i.e.,
diabetes, cardiovascular disease/hypertension, overweight/obese,
dyslipidemia)
- Acute respiratory distress syndrome (ARDS) severity (by Berlin
criteria) at time of intubation or ICU admission: 80% severe, 20%
moderate
- All had failed other therapies (steroids)
Narsoplimab treatment:
- 90% were intubated at initiation of narsoplimab treatment
- Narsoplimab was administered intravenously twice weekly; median
doses administered: 6 (range 3 to 8 doses)
Results:
- 80% recovered, survived and were discharged
- 2 deaths
- 76-year-old man from complications of pre-existing
cardiomyopathy; received 3 doses of narsoplimab
- 68-year-old man from multi-organ failure; narsoplimab dosing
was initiated after 13 days of intubation
Omeros plans to publish detailed data from the study in a
peer-reviewed scientific journal.
“We are grateful to Dr. Rambaldi and his colleagues for their
continuing work with narsoplimab and their dedication to treating
critically ill COVID-19 patients,” said Gregory A. Demopulos, M.D.,
chairman and chief executive officer of Omeros. “A greater focus in
the war against COVID-19 is now being placed globally on
therapeutics, and we believe that narsoplimab can contribute
meaningfully to that effort. Unlike other drugs for COVID-19,
narsoplimab targets the inflammatory endothelial disease – a
central driver across variants. Our discussions continue with
government agencies and NGOs in the US and internationally, and we
look forward to additional clinical trial data on narsoplimab in
critically ill COVID-19 patients.”
Narsoplimab is being evaluated in the I-SPY COVID-19 Trial, an
adaptive platform clinical trial enrolling critically ill COVID-19
patients. The trial is sponsored by Quantum Leap Healthcare
Collaborative and is funded in part by the United States government
through the Biomedical Advanced Research and Development Authority
(BARDA). Narsoplimab is the only complement inhibitor in the I-SPY
trial.
Narsoplimab holds Breakthrough Therapy and Orphan designations
in both hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA) and IgA nephropathy. The Biologics
License Application for narsoplimab in HSCT-TMA is under Priority
Review by FDA. The drug also is in Phase 3 clinical trials for IgA
nephropathy and atypical hemolytic uremic syndrome.
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed
to discovering, developing and commercializing small-molecule and
protein therapeutics for large-market and orphan indications
targeting inflammation, immunologic diseases (e.g.,
complement-mediated diseases and cancers) and central nervous
system disorders. Its commercial product OMIDRIA® (phenylephrine
and ketorolac intraocular solution) 1%/0.3% continues to gain
market share in cataract surgery. Omeros’ lead MASP-2 inhibitor
narsoplimab targets the lectin pathway of complement and is the
subject of a biologics license application under priority review by
FDA for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy. Narsoplimab is
also in multiple late-stage clinical development programs focused
on other complement-mediated disorders, including IgA nephropathy,
atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’
inhibitor of MASP-3, the key activator of the alternative pathway
of complement, is in a Phase 1 clinical trial, and the company’s
PDE7 inhibitor program OMS527, targeting addiction and movement
disorders, has successfully completed a Phase 1 trial. Omeros’
pipeline holds a diverse group of preclinical programs including a
proprietary-asset-enabled antibody-generating technology and a
proprietary GPCR platform through which it controls 54 GPCR drug
targets and their corresponding compounds. One of these novel
targets, GPR174, modulates a new cancer immunity axis recently
discovered by Omeros, and the company is advancing GPR174-targeting
antibodies and small-molecule inhibitors. 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 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, the risk that results of ongoing or future clinical
trials may differ substantially from those of compassionate-use
studies; risks associated with product commercialization and
commercial operations, regulatory processes and oversight, 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 (SEC) on March 1, 2021.
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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Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations 360.668.3701 jennifer@cwcomm.org
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