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 final
efficacy data including 60-day mortality from their recently
completed US-based, multi-center (10 sites), Phase 2 trial
(NCT04412057) of the human anti-LIGHT (TNFSF14) monoclonal antibody
CERC-002. This analysis updates the preliminary topline data
reported on January 5, 2021. 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 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 final analysis inclusive of the 60-day safety update
demonstrated the trial met its primary efficacy 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, p=0.044). Efficacy was highest in a
prespecified subpopulation of patients over the age of 60 (n=34,
p=0.042), the population most vulnerable to severe complications
and death with COVID-19 infection.
At both the 28-day and the 60-day final timepoints, an
approximately 50% trend in mortality reduction (22.5% vs 10.8%) was
observed.
CERC-002 showed statistically significant efficacy on top of
corticosteroids and standard of care treatments in COVID-19 ARDS:
over 90% of patients received concomitant systemic corticosteroids
and over 65% received remdesivir. CERC-002 was well-tolerated. No
drug-related serious adverse effects (SAEs) were reported in the
trial, and there was no increase in infections in CERC-002 treated
patients.
Cerecor has submitted applications to the U.S. Food and Drug
Administration (FDA) for Breakthrough Therapy and Fast Track
Designations. The Company plans to meet with FDA to discuss the
potential path to Emergency Use Authorization (EUA) and
approval.
“We would like to thank the patients who participated in this
landmark study. These results not only validate our hypothesis that
elevated LIGHT is a key driver of morbidity and mortality in
COVID-19 ARDS1, but also provide strong initial evidence that LIGHT
neutralization with CERC-002 in this setting may be able to save
lives and can spare patients from the need for ventilatory
support,” said H. Jeffrey Wilkins, MD, Chief Medical Officer of
Cerecor. “These results are all the more encouraging given
that this novel targeted therapy demonstrated efficacy and
excellent tolerability despite being administered over and above
standard of care including high dose systemic corticosteroids.”
“Despite progress with vaccinations, thousands of people in the
US and around the world continue to die of COVID-19 related
cytokine release syndrome and ARDS every day. There is an urgent
need for new safe and effective therapies to treat these patients,”
said Dr. David Perlin, Ph.D., Chief Scientific Officer and Senior
Vice President of the Center for Discovery and Innovation at the
Hackensack Meridian School of Medicine. “The need is all the
greater given the increasing levels of COVID-19 mutation and
resistance emerging in variants. Even with widespread vaccination
such therapies will be required for many years to come.”
A presentation of these data updates can be found on the
Investors section of 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 IL-1, IL-6, IL-8, IL-10, TNF and
GM-CSF. Therefore, LIGHT potentially 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
Chris BrinzeyWestwicke, an ICR
Companychris.brinzey@westwicke.com339-970-2843
or
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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