Quantum Leap Healthcare Collaborative (QLHC), sponsor of the
I-SPY COVID Trial, and Omeros Corporation (NASDAQ: OMER), developer
of the investigational agent narsoplimab, announced that enrollment
has been closed and data have been analyzed in the narsoplimab arm
of the I-SPY COVID Trial. The analysis in the randomized patient
population, including those who declined treatment after
randomization, shows that the addition of narsoplimab to treatment
of critically ill patients with COVID-19 reduces mortality risk
(hazard ratio [HR]=0.81 with probability [HR <1] equal to
0.77).
Neither futility nor graduation criteria were met in the
analysis of the randomized population at the time the narsoplimab
arm was terminated.
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.
Per the treatment protocol, narsoplimab was to be administered
as an intravenous infusion regimen: 4 mg/kg, given as a 30-minute
intravenous infusion (up to a maximum of 370 mg per infusion) twice
weekly for up to 4 weeks (i.e., a maximum of 9 doses) or until
hospital discharge.
The study did not identify any new safety signals for
narsoplimab in the setting of critically ill COVID-19 patients.
Narsoplimab was selected for inclusion in the I-SPY COVID Trial
because of its demonstrated ability to inhibit complement
activation, inflammation, and coagulation, the three components
that characterize COVID-19. Specifically, it is a fully human IgG4
monoclonal antibody against MASP-2, the effector enzyme of the
lectin pathway of complement. It inhibits the lectin pathway of
complement activation, an early and potent driver of SARS
COV-2-triggered inflammation, which, in severe disease, culminates
in hypocomplementemia with increased secondary infection risk and
in a devastating cytokine storm. Narsoplimab also acts as an
anticoagulant by inhibiting the MASP-2-mediated coagulation without
increasing bleeding risk.
The I-SPY COVID Trial is a collaboration between members of QLHC
and pharmaceutical partners such as Genentech, a member of the
Roche Group, and the United States Government (USG). This work is
supported in part by the Biomedical Advanced Research and
Development Authority, part of the office of the Assistant
Secretary for Preparedness and Response within the U.S. Department
of Health and Human Services, and the Department of Defense (DoD)
Joint Program Executive Office for Chemical, Biological,
Radiological and Nuclear Defense, in collaboration with the Medical
CBRN Defense Consortium. The Defense Threat Reduction Agency
enables USG and international partners to counter and deter weapons
of mass destruction and emerging threats.
About Quantum Leap Healthcare Collaborative
Quantum Leap Healthcare Collaborative is a 501C(3) charitable
organization established in 2005 as a collaboration between medical
researchers at University of California, San Francisco and Silicon
Valley entrepreneurs. Our mission is to integrate high-impact
research with clinical processes and systems technology, resulting
in improved data management and information systems, greater access
to clinical trial matching and sponsorship, and greater benefit to
providers, patients and researchers. Our goal is to improve and
save lives. Quantum Leap provides operational, financial, and
regulatory oversight to the I-SPY Trials. For more information,
visit www.QuantumLeapHealth.org.
About the I-SPY COVID Trial
The I-SPY COVID Trial (Investigation of Serial Studies to
Predict Your COVID Therapeutic Response with Biomarker Integration
and Adaptive Learning) is an adaptive platform trial designed to
increase trial efficiency by minimizing the number of participants
and time required to evaluate experimental and/or repurposed drugs.
The focus of the trial is to improve outcomes for severely-ill
COVID-19 patients—those who require at least 6L of high-flow oxygen
either by mask or nasal cannula, known as level 5 on the World
Health Organization (WHO) COVID scale, an 8-point ordinal scale of
clinical severity status. The primary endpoints include the time to
achieve level 4 or less for at least 48 hours on the WHO COVID
scale, the duration of time on a ventilator, and mortality.
The I-SPY COVID Trial is sponsored and managed by Quantum Leap
Healthcare Collaborative. For more information, visit
www.quantumleaphealth.org or www.ispytrials.org.
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.
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. A biologics license application (BLA) is pending before
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.
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.
Omeros 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 statements regarding
Omeros’ research and development programs and the therapeutic
application of research findings, 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, unproven preclinical and clinical development
activities, regulatory processes and oversight, challenges
associated with manufacture or supply of our investigational or
commercial products, delays in completion of ongoing or planned
clinical trials, 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 (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.
Source: Quantum Leap Healthcare Collaborative and Omeros
Corporation
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220915005722/en/
QLHC Contact: Jacqueline Murray Marketing and
Communications Director, Quantum Leap Healthcare
J.murray@quantumleaphealth.org (415) 839-8082
Omeros Contact: Jennifer Cook Williams Cook Williams
Communications, Inc. Investor and Media Relations IR@omeros.com
Omeros (NASDAQ:OMER)
Historical Stock Chart
From May 2023 to Jun 2023
Omeros (NASDAQ:OMER)
Historical Stock Chart
From Jun 2022 to Jun 2023