Omeros Announces Online Publication in Advance of ASH Annual Meeting Detailing Narsoplimab Treatment Under Compassionate Use of 15 Patients with Hematopoietic Stem Cell Transplant-associated Thrombotic Microangiopathy
03 Noviembre 2023 - 7:05AM
Business Wire
-- Poster Presentation Slated for Upcoming
Annual Meeting of the American Society of Hematology --
Omeros Corporation (Nasdaq: OMER) today announced online
publication of a report detailing treatment with narsoplimab of 15
adult and pediatric patients with hematopoietic stem cell
transplant-associated thrombotic microangiopathy (TA-TMA), 14 of
whom had “high-risk” TA-TMA. Narsoplimab is Omeros’ investigational
antibody targeting MASP-2, the effector enzyme of the lectin
pathway of the complement system. The report was authored by an
external group of investigators involved in the treatment of these
patients with narsoplimab provided under Omeros’ compassionate use
program.
The report will be featured as a poster presentation at the 65th
Annual Meeting of the American Society of Hematology (ASH), to be
held December 9-12, 2023 in San Diego. The abstract (#3543) is
available on the ASH website at www.hematology.org or by clicking
here.
The poster will be presented by Dr. Marta Castelli, Department
of Oncology and Hematology, University of Milan and Azienda
Socio-Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Details of the presentation are as follows:
Clinical Safety and Efficacy of
Narsoplimab in Pediatric and Adult Patients with
Transplant-Associated Thrombotic Microangiopathy: A Real-World
Experience (Abstract #3543) Session Name: 721. Allogeneic
Transplantation: Conditioning Regimens, Engraftment and Acute
Toxicities: Poster II Date: Sunday, December 10, 2023 Presentation
Time: 6:00 p.m. - 8:00 p.m. PT Location: San Diego Convention
Center, Halls G-H
About Narsoplimab
Narsoplimab, also known as “OMS721,” is an investigational fully
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 has
been demonstrated to leave intact the antibody-dependent classical
complement activation pathway, which is a critical component of the
acquired immune response to infection. A biologics license
application (BLA) is pending before the U.S. FDA for use of
narsoplimab in the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy (TA-TMA), and
Omeros expects to resubmit the BLA to include additional
information supporting approval of narsoplimab in this indication.
Narsoplimab is also in clinical development programs focused on
other complement-mediated disorders, including COVID-19. FDA has
granted narsoplimab breakthrough therapy and orphan drug
designations for TA-TMA and orphan drug status for the prevention
(inhibition) of complement-mediated thrombotic microangiopathies as
well as for the treatment of TA-TMA. The European Medicines Agency
has granted orphan drug designation to narsoplimab for treatment in
hematopoietic stem-cell transplant.
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. Omeros’
long-acting MASP-2 inhibitor OMS1029 is currently in a Phase 1
multi-ascending dose 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 and complement 3 glomerulopathy. Funded by the
National Institute on Drug Abuse, Omeros’ lead phosphodiesterase 7
inhibitor OMS527 is in clinical development for the treatment of
cocaine use disorder and, in addition, is being developed as a
therapeutic for other addictions as well as for a major
complication of treatment for movement disorders. Omeros also is
advancing a broad portfolio of novel immuno-oncology programs
comprised of two cellular and three molecular platforms. 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,” “expect,” “intend,” and similar
expressions and variations thereof. Forward-looking statements,
including statements regarding Omeros’ investigational drug
candidates, anticipated next steps in relation to the biologics
license application for narsoplimab or in relation to other
development programs 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 outcomes of regulatory processes in
relevant jurisdictions, unproven preclinical and clinical
development activities, the Company’s financial condition and
results of operations, regulatory processes and oversight,
challenges associated with manufacture or supply of our
investigational or clinical products, 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/20231103826894/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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