Expert Panel Points to Central Role of Endothelial Injury and Lectin Pathway Activation in Critically Ill COVID-19 Patients
September 03 2020 - 9:38AM
Business Wire
- Omeros’ investigational agent narsoplimab
discussed as a potentially highly effective therapy -
Omeros Corporation (Nasdaq: OMER) today announced that the
Demy-Colton Virtual Salon Series featured an expert discussion of
developments in the treatment of severe COVID-19. The panel
session, entitled Lessons from Bergamo: Discoveries in Treating
Critically-ill COVID-19 Patients, was held on September 2, 2020 and
included international experts in hematology, oncology and
complement science. The panel was moderated by Sara Jane Demy,
founder and chief executive officer of Demy-Colton. A replay of the
panel can be viewed here (free registration required).
The panel discussed the emerging evidence that endothelial
injury and the activation of the lectin pathway of complement are
central drivers of the acute respiratory distress syndrome (ARDS)
and thrombosis seen in critically ill COVID-19 patients.
Narsoplimab, Omeros’ investigational human monoclonal antibody
targeting mannan-binding lectin-associated serine protease-2
(MASP-2), the key effector of the lectin pathway of complement, was
identified as a potentially highly effective therapy to treat
critically ill COVID-19 patients.
Omeros previously announced positive results from the treatment
with narsoplimab of six critically ill COVID-19 patients under a
compassionate use protocol. All patients initially required
mechanical ventilation and, following treatment with narsoplimab,
all recovered, survived and were discharged from the hospital.
About Narsoplimab
Narsoplimab, also known as “OMS721,” is an investigational human
monoclonal antibody targeting mannan-binding lectin-associated
serine protease-2 (MASP-2), a novel pro-inflammatory protein target
and the effector enzyme of the lectin pathway of complement.
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. Omeros controls the worldwide rights to MASP-2 and all
therapeutics targeting MASP-2.
Phase 3 clinical programs are in progress for narsoplimab in
hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA), in immunoglobulin A (IgA) nephropathy,
and in atypical hemolytic uremic syndrome (aHUS). The FDA has
granted narsoplimab breakthrough therapy designations for HSCT-TMA
and for IgA nephropathy; orphan drug status for the prevention
(inhibition) of complement-mediated thrombotic microangiopathies,
for the treatment of HSCT-TMA and for the treatment of IgA
nephropathy; and fast track designation for the treatment of
patients with aHUS. The European Medicines Agency has granted
orphan drug designation to narsoplimab for treatment in HSCT and
for treatment of primary IgA nephropathy.
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, complement-mediated diseases, disorders of
the central nervous system and immune-related diseases, including
cancers. In addition to its commercial product OMIDRIA
(phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros
has multiple late-stage clinical development programs focused on
complement-mediated disorders, including COVID-19, and substance
abuse. A rolling biologics license application for narsoplimab, the
company’s lead MASP-2 inhibitor, in hematopoietic stem cell
transplant-associated thrombotic microangiopathy is being completed
for submission to the U.S. FDA. Omeros also has a diverse group of
preclinical programs including GPR174, a novel target in
immuno-oncology that modulates a new cancer immunity axis recently
discovered by Omeros. Small-molecule inhibitors of GPR174 are part
of Omeros’ proprietary G protein-coupled receptor (GPCR) platform
through which it controls 54 new GPCR drug targets and their
corresponding compounds. The company also exclusively possesses a
novel antibody-generating platform.
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,” “can,” “could,” “estimate,”
“expect,” “goal,” “intend,” “likely”, “look forward to,” “may,” “on
track,” “plan,” “potential,” “predict,” “project,” “prospects,”
“scheduled,” “should,” “slated,” “targeting,” “will,” “would” and
similar expressions and variations thereof. Forward-looking
statements, including statements regarding anticipated regulatory
submissions, the timing and results of ongoing or anticipated
clinical trials, and the therapeutic application of Omeros’
investigational product, 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,
availability and timing of data from clinical trials and the
results of such trials, 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 for the year
ended December 31, 2019, filed with the Securities and Exchange
Commission (SEC) on March 2, 2020, as supplemented by its Quarterly
Report on Form 10-Q filed with the SEC on August 10, 2020 and
subsequent filings with the SEC. 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
any 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/20200903005555/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations 360.668.3701 jennifer@cwcomm.org
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