Cerecor Announces FDA Acceptance of Investigational New Drug Application for CERC-007 for the Treatment of Still’s Disease
December 22 2020 - 1:00PM
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 its
Investigational New Drug Application (IND) to study the use of
CERC-007 to treat Still’s disease has been accepted by the United
States Food and Drug Administration (FDA) and is now open. CERC-007
is a high affinity, fully human anti-IL-18 monoclonal antibody
(mAb). The first study will be a global multicenter Phase 1b
clinical trial in adult onset Still’s disease and is planned to
start in the first quarter of 2021. Initial data is expected in the
second quarter of 2021.
“Adult onset Still’s disease (AOSD) is a rare inflammatory
disease resulting in joint damage, high fever and rashes," said H.
Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor. "The
hallmark of AOSD is elevated IL-18 levels. Targeting IL-18 using
CERC-007 is a novel therapeutic approach for the treatment of
AOSD."
The planned Phase 1b clinical trial will be a global
multi-center, open-label trial of CERC-007 that will enroll
approximately 12 subjects with active AOSD. The primary objectives
of the study will be to determine the safety and tolerability of
CERC-007, and assess preliminary efficacy as measured by reductions
in systemic clinical manifestations and markers of inflammation in
subjects with AOSD.
About Still’s diseaseStill's disease is a
serious and rare auto-inflammatory disorder that affects the entire
body. There are two major forms of the disease: adult onset Still’s
disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA).
AOSD and sJIA share common clinical manifestations, including
episodes of high, spiking fevers, rash, joint pain, muscle pain,
sore throat, multiorgan involvement and elevated levels of
IL-18.
About CERC-007CERC-007 is a high affinity,
fully human monoclonal antibody targeting the proinflammatory
cytokine IL-18. It is in development for multiple auto-immune
diseases, including Still’s disease (adult onset Still’s disease
(AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and
multiple myeloma (MM).
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 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
Cerecor (NASDAQ:CERC)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cerecor (NASDAQ:CERC)
Historical Stock Chart
From Apr 2023 to Apr 2024