Omeros’ Narsoplimab Pivotal Trial Data to Be Shared as an Oral Presentation at the European Hematology Association Congress
13 May 2021 - 10:30PM
Business Wire
Omeros Corporation (Nasdaq: OMER) today announced that data on
organ function improvement from Omeros’ pivotal trial of
narsoplimab for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy (HSCT-TMA) will be
shared as an oral presentation at the 2021 European Hematology
Association (EHA) Virtual Congress. The presentation, entitled
Narsoplimab (OMS721) Treatment Contributes to Improvements in Organ
Function in Adult Patients with High-Risk Transplant-Associated
Thrombotic Microangiopathy, will be delivered by Miguel-Angel
Perales, M.D., Chief of Adult Bone Marrow Transplant Service at
Memorial Sloan Kettering Cancer Center.
Dr. Perales’ oral presentation will be available on demand
through the EHA Virtual Congress platform to registered meeting
attendees beginning Friday, June 11, 2021 at 9:00 am CEST / 3:00 am
EDT. The presentation abstract (S241) can be accessed on EHA’s
website.
About Hematopoietic Stem Cell Transplant-associated
Thrombotic Microangiopathy
Hematopoietic stem cell transplant-associated thrombotic
microangiopathy (HSCT-TMA) is a significant and often lethal
complication of stem cell transplantation. This condition is a
systemic, multifactorial disorder caused by endothelial cell damage
induced by conditioning regimens, immunosuppressant therapies,
infection, graft-versus-host disease, and other factors associated
with stem cell transplantation. Endothelial damage, which activates
the lectin pathway of complement, plays a central role in the
development of HSCT-TMA. The condition occurs in both autologous
and allogeneic transplants but is more common in the allogeneic
population. In the United States and Europe, approximately 25,000
to 30,000 allogeneic transplants are performed annually. Recent
reports in both adult and pediatric allogeneic stem cell transplant
populations have found an approximately 40-percent incidence of
HSCT-TMA, and high-risk features may be present in up to 80 percent
of these patients. In severe cases of HSCT-TMA, mortality can
exceed 90 percent and, even in those who survive, long-term renal
sequalae (e.g., dialysis) are common. There is no approved therapy
or standard of care for HSCT-TMA.
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.
A biologics license application (BLA) is under priority review
by the U.S. FDA for use of narsoplimab in the treatment of
HSCT-TMA, and the drug is in Phase 3 clinical programs for
immunoglobulin A (IgA) nephropathy and atypical hemolytic uremic
syndrome (aHUS). Narsoplimab is also being evaluated for the
treatment of COVID-19 as a part of the I-SPY-COVID-19 platform
trial sponsored by Quantum Leap Healthcare Collaborative. 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, 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.
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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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