Cerecor Announces Peer-Reviewed Publication Highlighting the Role of the Inflammatory Cytokine, LIGHT, in COVID-19 ARDS
August 13 2020 - 07:00AM
Cerecor Inc. (NASDAQ : CERC), a biopharmaceutical company focused
on becoming a leader in development and commercialization of
treatments for rare pediatric and orphan diseases, today announced
the publication of a peer-reviewed paper demonstrating
significantly elevated free LIGHT levels in the serum of
hospitalized patients with severe COVID-19 infection. The
publication, entitled Levels of the TNF related cytokine, LIGHT,
increased in hospitalized COVID-19 patients with Cytokine Release
Syndrome and ARDS in the Journal mSphere by David S. Perlin et al,
highlights the potential role of the inflammatory cytokine, LIGHT
in the development of COVID-19 ARDS. Cerecor believes that the
publication supports its clinical program evaluating CERC-002, the
only clinical stage anti-LIGHT monoclonal antibody, as a potential
treatment for patients with severe COVID-19 acute respiratory
distress syndrome (“ARDS”). A link to the publication can be
accessed here.
Dr. Perlin, chief scientific officer, senior vice president of
the Center for Discovery and Innovation, and Professor of Medical
Sciences at the Hackensack Meridian School of Medicine, said,
“Identifying the role of LIGHT in patients infected with SARS-CoV-2
(“COVID-19”) is a seminal finding pointing to understanding the
potential mechanism by which COVID-19 infection leads to ARDS and
suggests a promising new strategy to treat these
patients.”
“We believe these compelling results strongly support our
hypothesis that LIGHT plays an important role in COVID-19 ARDS and
indicated that a clinical trial of CERC-002 in COVID-19 ARDS was a
logical next step,” said Dr. Garry Neil, chief scientific officer
at Cerecor. “This study is now well underway, and we expect topline
results in the fourth quarter of 2020. We are further exploring the
potential role of LIGHT as a driver of and biomarker for ARDS in
additional studies of both COVID-19 infected patients as well as in
a broader patient population of non-COVID-19 associated ARDS
patients. From these studies we hope to learn more about the role
of LIGHT in ARDS in general, while potentially opening a path for
treatment of a broader population of ARDS patients who have high
mortality and, in many cases, lack effective treatment
options.”
Role of LIGHT in Acute Inflammatory
Response
LIGHT (homologous to Lymphotoxin, exhibits inducible expression
and competes with HSV glycoprotein D for binding to herpesvirus
entry mediator, a receptor expressed on T lymphocytes) is a
cytokine with inflammatory actions encoded by the Tumor Necrosis
Factor Super Family 14 gene. LIGHT has been shown to play a key
role in the immune response to viral pneumonia. LIGHT plays an
important role in regulating immune responses in the lung, gut and
skin. It stimulates T Cell and B Cell response as well as induces
the release of other cytokines such as IL1, IL6, IL-8, IL-10, TNF
and GM-CSF.
CERC-002 (anti-LIGHT monoclonal antibody)
CERC-002 is a first in class fully human anti-LIGHT (TNFSF14)
monoclonal antibody licensed from Kyowa Kirin Co., Ltd. It offers
the potential to treat cytokine release syndrome-induced COVID-19
ARDS in the near-term and broader ARDS indication beyond. It is
currently being developed as a treatment for pediatric Crohn’s
disease and now cytokine release syndrome induced COVID-19 ARDS.
Cerecor has also developed a validated serum/plasma free LIGHT
assay in collaboration with Myriad RBM. This assay has shown to
have high sensitivity and specificity for free LIGHT which has been
shown to be elevated in patients with active Crohn’s disease and
with COVID-19 related ARDS.
About the CERC-002 COVID-19 ARDS
Trial
Cerecor is sponsoring a randomized, multicenter U.S.,
double-blind, placebo-controlled clinical study that will enroll
approximately 82 subjects hospitalized with COVID-19 ARDS. The
primary objective of the study is to demonstrate that treatment
with CERC-002 results in fewer instances of respiratory failure and
death versus the standard of care. Patients in the CERC-002 arm
will receive a single dose of drug and be followed for 28 days. Key
secondary endpoints include intensive care unit length of stay,
hospital length of stay, and oxygen saturation at the end of the
study. The trial is currently underway and enrolling patients in
the U.S. with topline data expected in the fourth quarter of
2020.
About Cerecor
Cerecor is a biopharmaceutical company focused on becoming a
leader in development and commercialization of treatments for rare
pediatric and orphan diseases. The company is advancing its
clinical-stage pipeline of innovative therapies that address unmet
patient needs within rare pediatric and orphan diseases. The
company's pediatric rare disease pipeline includes CERC-801,
CERC-802 and CERC-803 ("CERC-800 compounds"), which are therapies
for inherited metabolic disorders known as congenital disorders of
glycosylation. The U.S. Food and Drug Administration ("FDA")
granted Rare Pediatric Disease Designation (“RPDD”) and Orphan Drug
Designation ("ODD") to all three CERC-800 compounds, thus
potentially qualifying the Company to receive a Priority Review
Voucher ("PRV") upon approval of each new drug application ("NDA").
The company is also developing CERC-002, CERC-006 and CERC-007.
CERC-002 is an anti-LIGHT monoclonal antibody being developed for
the treatment of COVID-19 acute respiratory distress syndrome and
pediatric-onset Crohn's disease. CERC-006 is a dual mTOR inhibitor
being developed for the treatment of complex lymphatic
malformations and has been granted ODD and RPDD by the FDA, thus
potentially qualifying the company to receive a fourth PRV upon
approval of an NDA. CERC-007 is an anti-IL-18 monoclonal antibody
being developed for the treatment of autoimmune inflammatory
diseases such as adult onset Stills disease and multiple
myeloma.
For more information about Cerecor, please visit
www.cerecor.com.
Forward-Looking Statements
This press release may include forward-looking statements made
pursuant to the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are statements that are not historical
facts. Such forward-looking statements are subject to significant
risks and uncertainties that are subject to change based on various
factors (many of which are beyond Cerecor’s control), which could
cause actual results to differ from the forward-looking statements.
Such statements may include, without limitation, statements with
respect to Cerecor’s plans, objectives, projections, expectations
and intentions and other statements identified by words such as
“projects,” “may,” “might,” “will,” “could,” “would,” “should,”
“continue,” “seeks,” “aims,” “predicts,” “believes,” “expects,”
“anticipates,” “estimates,” “intends,” “plans,” “potential,” or
similar expressions (including their use in the negative), or by
discussions of future matters such as: the development of product
candidates or products; timing and success of trial results and
regulatory review; potential attributes and benefits of product
candidates; and other statements that are not historical. These
statements are based upon the current beliefs and expectations of
Cerecor’s management but are subject to significant risks and
uncertainties, including: drug development costs, timing and other
risks, including reliance on investigators and enrollment of
patients in clinical trials, which might be slowed by the COVID-19
pandemic; regulatory risks; Cerecor's cash position and the
potential need for it to raise additional capital; general economic
and market risks and uncertainties, including those caused by the
COVID-19 pandemic; and those other risks detailed in Cerecor’s
filings with the Securities and Exchange Commission. Actual results
may differ from those set forth in the forward-looking statements.
Except as required by applicable law, Cerecor expressly disclaims
any obligations or undertaking to release publicly any updates or
revisions to any forward-looking statements contained herein to
reflect any change in Cerecor’s expectations with respect thereto
or any change in events, conditions or circumstances on which any
statement is based.
For media and investor inquiries
James Harrell Investor RelationsChief Commercial OfficerCerecor
Inc.jharrell@cerecor.com623.439.2220 office
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