Omeros Corporation Reports Narsoplimab Treatment Results in Critically Ill COVID-19 Patients in I-SPY COVID Trial
September 15 2022 - 09:06AM
Business Wire
-- Reduction in Mortality Risk with Narsoplimab
--
Omeros Corporation (Nasdaq: OMER) today reported results from
the narsoplimab arm of the I-SPY COVID Trial, sponsored by Quantum
Leap Healthcare Collaborative (QLHC). Analysis in the randomized
patient population shows that the addition of narsoplimab to
treatment of critically ill patients with COVID-19 reduces the
mortality risk (hazard ratio [HR]=0.81, with probability [HR <1]
equal to 0.77). Narsoplimab showed the largest reduction in
mortality risk to date across all drugs reported from the I-SPY
COVID Trial.
There were 91 patients randomized to the narsoplimab arm of the
trial across 27 participating US sites. The 91 randomized patients
were compared to the 116 patients concurrently randomized to the
control arm. All patients received standard of care including
dexamethasone and remdesivir. Bayesian statistics were prespecified
and employed for analyses.
Narsoplimab was to be administered at a dose of 4 mg/kg given as
a 30-minute intravenous infusion (up to a maximum of 370 mg per
infusion) twice weekly for the earlier of a total of 4 weeks (i.e.,
9 doses) or until hospital discharge. However, in approximately
half of the patients who died in the narsoplimab group, narsoplimab
was not given or was prematurely stopped, with those patients dying
9 to 35 days later. Despite narsoplimab treatment exposure in a
limited number of patients in this trial, a substantial efficacy
signal was observed in reducing the risk of mortality for
critically ill COVID-19 patients.
Narsoplimab was not observed to shorten the time to recovery in
critically ill patients with COVID-19 in this study. The study did
not identify any new safety signals for narsoplimab in the setting
of critically ill COVID-19 patients.
The I-SPY COVID Trial was designed for rapid screening of agents
that show promise for two primary endpoints in critically ill
COVID-19 patients: the time to recovery (defined as reduction in
oxygen demand) and the risk of mortality. The study utilizes QLHC’s
adaptive platform trial design methodology, which focuses on the
simultaneous, efficient assessment of multiple investigational
agents. To streamline enrollment and allow rapid assessment of
multiple drugs as required during the pandemic, the platform
trial’s initial design included a requirement that patients be
randomized prior to consenting to trial participation. While the
motivation for this sequence and the analysis of the consented
population is outlined in The I-SPY COVID
Adaptive Platform Trial for COVID-19 Acute Respiratory Failure:
Rationale, Design and Operations, such analyses have risk of
bias. To protect against potential bias associated with analysis
only in the consented population, QLHC also prespecified analyses
based on all randomized patients (the industry-standard
intent-to-treat population).
Substantial imbalance in the consented population was detected
and created a marked and statistically significant bias against the
narsoplimab arm, rendering analysis of the consented population
meaningless. However, as pre-specified by the analysis plan, the
I-SPY trial’s data monitoring committee terminated the narsoplimab
arm based on the biased analyses in the consented population prior
to reaching the maximum of 125 patients. Neither the trial’s
futility nor graduation criteria had been met in the analysis of
the randomized population at the time the narsoplimab arm was
terminated.
Avoiding similarly biased outcomes in future trial arms, QLHC
subsequently revised the protocol for its I-SPY COVID Trial to
obtain patient consent prior to randomization.
“We appreciate QLHC’s efforts to accelerate the identification
of effective therapeutics against COVID-19 and are pleased that,
despite the trial’s challenges inherent in that objective, a
survival benefit was reported for narsoplimab,” said Gregory A.
Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer.
“Work continues in our laboratories both in Seattle and at the
University of Cambridge to build on our published findings on the
role of the lectin pathway and the MASP-2 inhibitor narsoplimab in
severe acute COVID-19, PASC or long COVID, and other related
life-threatening infections as well as on our set of assays to
identify at-risk patients early in these diseases.”
Narsoplimab has been used internationally under an expanded
access program to treat successfully patients with severe acute
COVID-19. In addition, recent publications demonstrate the role of
lectin pathway hyperactivation in hypocomplementemia and secondary
infection risk in patients with severe COVID-19 and narsoplimab’s
ability to restore complement function in those patients.
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
(BLA) pending before FDA for the treatment of hematopoietic stem
cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
Narsoplimab is also in multiple late-stage clinical development
programs focused on other complement-mediated disorders, including
IgA nephropathy, COVID-19, and atypical hemolytic uremic syndrome.
Omeros’ long-acting MASP-2 inhibitor OMS1029 is currently in a
Phase 1 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 (PNH), complement 3 (C3) glomerulopathy and one or
more related indications. 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, including expectations with
regard to future development of narsoplimab for treatment of
COVID-19, 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, 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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version on businesswire.com: https://www.businesswire.com/news/home/20220915005732/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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