Cerecor Resumes Phase 1b Clinical Trial of CERC-002 for the Treatment of Severe Pediatric Onset Crohn’s Disease
August 26 2020 - 7:00AM
Cerecor Inc. (NASDAQ : CERC), a biopharmaceutical company focused
on becoming a leader in development and commercialization of
treatments for rare and orphan diseases, today announced it has
resumed the Phase 1b clinical study of CERC-002 in anti-TNF
refractory adult Crohn’s patients with the lifting of the
moratorium on elective endoscopy resulting from the COVID-19
pandemic. CERC-002 is a first-in-class fully human anti-LIGHT
(TNFSF14) monoclonal antibody currently being developed as a
treatment for severe pediatric onset Crohn’s disease as well as in
a placebo-controlled proof-of-concept trial evaluating the safety
and efficacy in patients with COVID-19 cytokine storm-induced Acute
Respiratory Distress Syndrome (ARDS).
The open-label, dose-escalating, signal-finding Phase 1b
clinical study is designed to assess the safety, tolerability, and
short-term efficacy of CERC-002 in adult subjects with
moderate-to-severe Crohn’s disease who have previously failed
treatment with anti-TNF agents. The Company expects to announce
topline data in the first quarter of 2021.
“We are excited to now have two active clinical studies
evaluating the safety and efficacy of the anti-LIGHT monoclonal
antibody, CERC-002,” stated Dr. H. Jeffery Wilkins, chief medical
officer at Cerecor. “There has been an increasing level of
scientific evidence supporting the rationale behind LIGHT being a
key target for immune conditions of the mucosa of the lung and
gut. We believe CERC-002 may have the potential to treat both
patients with Crohn’s disease refractory to biologics and patients
with COVID-19 ARDS, both of which 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 and gut. 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, TNFs 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 Cerecor
Cerecor is a biopharmaceutical company focused on becoming a
leader in 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
("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
severe pediatric-onset Crohn's disease, and is also in clinical
trial for COVID-19 acute respiratory distress syndrome.
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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