-- Webcast Scheduled for Today at 8:30am
ET--
Omeros Corporation (Nasdaq: OMER) today announced final data
from its pivotal trial for narsoplimab in hematopoietic stem cell
transplant-associated thrombotic microangiopathy (HSCT-TMA), an
often-lethal complication of stem-cell transplantation for which
there is no approved therapy. Narsoplimab, an inhibitor of
mannan-binding lectin-associated serine protease-2 (MASP-2), the
effector enzyme of the lectin pathway and activator of the
coagulation cascade, is being studied for the treatment of HSCT-TMA
patients at high risk for poor outcomes. Narsoplimab has been
awarded Breakthrough Therapy designation by U.S. FDA and is the
subject of a rolling Biologics License Application (BLA) for
HSCT-TMA. The nonclinical and CMC modules of the rolling BLA have
already been submitted, and the final sections of the clinical
module are in the publishing phase during which finalized documents
are electronically processed and integrated for submission in the
format required by FDA.
Omeros previously presented preliminary data from its pivotal
HSCT-TMA trial. The final data reported today are those that are
included in the BLA. In the 28-patient single-arm, open-label
pivotal trial in adult HSCT-TMA patients, treatment consisted of
narsoplimab administered intravenously once weekly for up to 8
weeks with an extended follow-up period. The study’s patient
population was very ill, with the large majority of study patients
having multiple comorbidities at baseline (e.g., graft-versus-host
disease, significant infections, multi-organ dysfunction, etc.).
The FDA-agreed primary endpoint (complete response) required
clinical improvement in TMA markers (platelet count and lactate
dehydrogenase [LDH]) and in organ function (renal, pulmonary,
gastrointestinal or neurological) or freedom from transfusion.
Secondary endpoints included 100-day and overall survival as well
as change from baseline for individual laboratory markers
(platelets, LDH, haptoglobin, hemoglobin and creatinine).
The final results on primary and key secondary endpoints
include:
- 61% (95% CI: 40.6% to 78.5%) complete response rate (CRR) in
the full analysis set (FAS; patient receiving at least one dose of
narsoplimab; p<0.0001 compared to 15% efficacy threshold agreed
with FDA)
- 74% (95% CI: 51.6% to 89.8%) CRR in the per-protocol (PP)
population (patients receiving the protocol-specified narsoplimab
treatment for at least 4 weeks; p<0.0001 compared to the 15%
threshold)
- 100-day survival was 68% in the FAS, 83% in the PP population
and 94% in complete responders
- Median overall survival was 274 days in the FAS, 361 days in
the PP population and, for complete responders, was not estimable
(more than half of the responders were alive at last
follow-up)
Similar responses were observed across all patient subgroups
defined by baseline characteristics, transplant characteristics and
transplant complications. The majority of individual laboratory
markers showed statistically significant improvement with the
remainder numerically improving. Adverse events were typical of the
post-HSCT population (e.g., fever, diarrhea, vomiting, nausea and
neutropenia) and no safety signal of concern was identified. Six
deaths occurred in the study, all from causes common in HSCT.
The data will be presented today at 8:30 a.m. ET by Miguel
Perales, M.D, Chief of the Adult Bone Marrow Transplant Service at
Memorial Sloan Kettering Cancer Center, and 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.
Webcast Details
To access the live conference call via phone, please dial (844)
831-4029 from the United States and Canada or (920) 663-6278
internationally. The participant passcode is 7876969. Please dial
in approximately 10 minutes prior to the start of the call.
To access the live or subsequently archived webcast and
presentation materials on the internet, click here or go to the
company’s website at www.omeros.com and select “Events” under the
Investors section of the website.
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/20201022005632/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations 360.668.3701 jennifer@cwcomm.org
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