Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company
focused on becoming a leader in the development and
commercialization of treatments for rare and orphan diseases, today
announced results from its exploratory Phase 2 US-based randomized,
double-blind, placebo-controlled proof of concept trial
(NCT04412057) of the human anti-LIGHT (TNFSF14) monoclonal antibody
CERC-002. All patients in this trial were hospitalized with
COVID-19 associated pneumonia and mild-to-moderate acute
respiratory distress syndrome (“ARDS”). A total of 83 patients (82
treated) were randomized 1:1 to receive standard of care at the
sites plus either a single dose of 1,200 mg of CERC-002 or placebo
subcutaneously. Due to the protocol allowing patients to receive
high flow oxygen prior to randomization, 62 patients were included
in the intention-to-treat (ITT) analysis of the primary endpoint.
The trial demonstrated robust improvement in the primary
endpoint (proportion of patients alive and free of respiratory
failure over the 28-day study period) compared to placebo in
COVID-19 patients with ARDS treated with a single dose of the
anti-LIGHT monoclonal antibody CERC-002 (n=62, OR = 2.62, p=0.059;
these data trended towards statistical significance, p≤0.05). A
prespecified subpopulation of patients 60 years of age showed
similar improvement in the primary endpoint (n=33, OR = 3.38,
p=0.054). CERC-002-treated patients in the
subpopulation of patients 60 years of age also had a shorter
average hospital stay compared with placebo-treated patients.
These data further showed a numerical mortality benefit favoring
CERC-002 with 4 patients dying on active drug and 9 on placebo as
of December 31, 2020. These data will be updated and analyzed at
the 60-day timepoint.
Importantly, >90% of patients received concomitant systemic
corticosteroids and >60% received remdesivir. Thus CERC-002
showed activity on top of corticosteroids in COVID-19 ARDS.
No drug-related serious adverse effects (SAEs) were reported in
the trial, and there was no increase in infections in CERC-002
treated patients. The large majority of hospitalized COVID-19
patients had elevated LIGHT (TNFSF14) levels in their serum upon
admission. Consistent with its targeted mechanism of action,
CERC-002 dramatically and rapidly reduced LIGHT levels in nearly
all treated patients, while patients on placebo saw a rise in LIGHT
levels through Day 5. LIGHT levels were higher in the older
patients who have a higher risk of death and respiratory failure.
Moreover, these data demonstrate that corticosteroid therapy does
not seem to affect serum LIGHT levels and that CERC-002 provides
additional benefit on top of corticosteroid therapy.
“I would first like to thank the patients, their families, and
the investigators for their participation in this important study,”
said Jeff Wilkins, Chief Medical Officer of Cerecor. “We are very
excited about these results as they demonstrate the therapeutic
potential of CERC-002. In spite of recent advances in the treatment
of COVID-19 ARDS patients, COVID-19 remains a global health threat,
and this study demonstrates the potential for significant
improvement for patients most at risk.”
Garry Neil, Chief Scientific Officer added, “Cytokine release
syndrome remains a major cause of death and morbidity in COVID-19
ARDS. We and others have shown that the important
immunoregulatory cytokine, LIGHT, plays a critical role in this
syndrome – and that such patients have elevated LIGHT levels in
their serum, roughly correlating with disease activity.1 The
data from this proof-of-concept study clearly demonstrate that
neutralizing LIGHT with CERC-002 can improve clinical outcomes for
COVID-19 ARDS patients, even when given to patients on concomitant
steroids and remdesivir. In this study, CERC-002 was safe and well
tolerated in sick, older, steroid-treated patients in the ICU.
These data greatly increase our confidence in the mechanism of
action and clinical utility of CERC-002, in COVID-19 ARDS and in
other immune diseases. We believe we now have sufficient
information to work with the FDA to design a registration trial for
COVID-19 ARDS patients. We believe that these data also
provide valuable insights that we can apply to other programs
including our Crohn’s disease program.”
A presentation of these data updates can be found on the
“Company Information” page of the “Investors” section on the
Cerecor website linked here.
CERC-002 (anti-LIGHT monoclonal antibody)
CERC-002 is a fully human anti-LIGHT or tumor necrosis factor
superfamily member 14 (TNFSF14) monoclonal antibody licensed from
Kyowa Kirin Co., Ltd. It is the only clinical stage anti-LIGHT
therapy and has the potential to treat a number of LIGHT-associated
immune diseases including cytokine storm-induced COVID-19 ARDS. It
is currently in development for pediatric onset Crohn’s disease and
cytokine storm induced COVID-19 ARDS. Cerecor has also developed a
validated, high sensitivity serum/plasma free LIGHT assay in
collaboration with Myriad RBM.
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 TNFSF14 gene. 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. It thus plays a key role in immune responses to viral
pneumonia and other diseases.
About Cerecor
Cerecor is a biopharmaceutical company focused on becoming a
leader in the development and commercialization of treatments for
rare and orphan diseases. The company is advancing its
clinical-stage pipeline of innovative therapies that address unmet
patient needs within rare and orphan diseases. The company's
rare disease pipeline includes CERC-801, CERC-802 and CERC-803,
which are in development for congenital disorders of glycosylation
and CERC-006, an oral mTORc1/c2 inhibitor in development for the
treatment of complex lymphatic malformations. The company is also
developing two monoclonal antibodies, CERC-002, and CERC-007.
CERC-002 targets the cytokine LIGHT (TNFSF14) and is in clinical
development for treatment of severe pediatric-onset Crohn's
disease, and COVID-19 acute respiratory distress syndrome.
CERC-007 targets the cytokine IL-18 and is in clinical development
for the treatment of Still’s disease (adult onset Still’s disease
(AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and
multiple myeloma (MM). CERC-006, 801, 802 and 803 have all received
Orphan Drug Designation and Rare Pediatric Disease Designation,
which makes all four eligible for a priority review voucher upon
FDA approval.
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 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
1 Perlin DS, Zafir-Lavie I, Roadcap L, et al Levels of the
TNF-Related Cytokine LIGHT Increase in Hospitalized COVID-19
Patients with Cytokine Release Syndrome and ARDS. mSphere. 2020 Aug
12;5(4):e00699-20.
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