Cerecor Announces FDA Acceptance of Investigational New Drug Application for CERC-803 to Treat Leukocyte Adhesion Deficiency ...
December 01 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 that the
U.S. Food and Drug Administration (FDA) has accepted its
Investigational New Drug Application (IND) to study the use of
CERC-803 to treat Leukocyte Adhesion Deficiency Type II (LAD II).
The company plans to initiate a pivotal trial of CERC-803 in LAD-II
(SLC35C1-CDG) by the first half of 2021 and anticipates topline
data in the second half of 2021.
“There are currently no FDA-approved therapies for patients
suffering from LAD-II” said H. Jeffrey Wilkins, MD, Chief Medical
Officer of Cerecor. “LAD-II is caused by genetic mutations that
result in deficiency in expression of surface adhesion molecule
selectin, leading to defective leukocyte functions. This is a
pediatric disease with the first symptoms appearing in infancy with
recurrent bacterial infections, growth retardation, facial
dysmorphism, and severe intellectual deficit as they continue to
grow. We are excited to advance this program into the clinic.”
The FDA granted Orphan Drug Designation (ODD) and Rare Pediatric
Disease Designation (RPDD) to CERC-803, thus potentially qualifying
the Company to receive a Priority Review Voucher (PRV) upon
approval of a new drug application (NDA).
About CERC-800sCERC-801, CERC-802 and CERC-803
are monosaccharide therapies with known therapeutic utility for the
treatment of select congenital disorders of glycosylation (CDGs).
Oral administration at therapeutic doses of CERC-801, CERC-802, and
CERC-803 replenishes critical metabolic intermediates that are
reduced or absent due to genetic mutation, overcoming single enzyme
defects in respective CDGs to support glycoprotein synthesis,
maintenance and function.
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 (CERC-800 compounds), which are therapies for
inherited metabolic disorders known as congenital disorders of
glycosylation. The FDA granted RPDD and ODD to all three CERC-800
compounds, thus potentially qualifying the Company to receive a PRV
upon approval of each 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 being studied 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 Still’s disease and multiple
myeloma.
For more information about Cerecor, please visit
www.cerecor.com.
Forward-Looking StatementsThis 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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