Cerecor Announces Last Patient Enrolled in Phase 2 Clinical Trial with CERC-501 for Smoking Cessation
September 06 2016 - 9:10AM
Business Wire
Top-Line Phase 2 Data Expected in December
2016
Cerecor Inc. (NASDAQ:CERC), a clinical-stage biopharmaceutical
company developing treatments to make a difference in the lives of
patients with neurological and psychiatric disorders, today
announced that it has completed patient enrollment in its Phase 2
clinical trial for CERC-501, “A Randomized, Double-Blind,
Placebo-Controlled, Cross-over Design Study of CERC-501 in a Human
Laboratory Model of Smoking Behavior.” The Company expects to
report top-line data from this trial in the beginning of December
2016.
Cerecor launched its Phase 2 clinical trial with CERC-501 for
smoking cessation in February 2016. The double-blind,
placebo-controlled, crossover study randomized 71 subjects who are
heavy cigarette smokers and currently not seeking treatment for
tobacco use disorder. In period one, half the subjects in each
group received CERC-501 and the other half received placebo. Next,
“crossover” occurred and subjects received the opposite treatment
during period two, after a “wash-out period.” The crossover design
allows for subjects to be their own control. The primary objective
of the study is to evaluate the effect of CERC-501 compared to
placebo on symptoms of tobacco withdrawal and smoking
behaviors.
About CERC-501CERC-501 is a potent and selective oral
kappa opioid receptor (“KOR”) antagonist being developed to treat
substance use disorders and as an adjunctive treatment of major
depressive disorder (“MDD”). KORs have been shown to play an
important role in stress, mood and addiction. CERC-501 has been
observed to have positive activity in animal models of depression,
nicotine withdrawal and alcohol dependence, and it has been
generally well tolerated in three human clinical trials.
In addition to Cerecor’s Phase 2 trial in smokers, three
externally-funded clinical trials are being conducted to evaluate
the use of CERC-501 in treating depressive symptoms, stress-related
smoking relapse and cocaine addiction. One study is being conducted
under the auspices of the National Institute of Mental Health, the
second is a collaboration between Cerecor and Yale investigators
with funding from the National Institutes of Health and the third
is being conducted at Rockefeller University Hospital with funding
from a private foundation. Cerecor is planning to initiate a Phase
2 study with CERC-501 as an adjunctive treatment of MDD in
2017.
About CerecorCerecor is a clinical-stage
biopharmaceutical company developing innovative drug candidates to
make a difference in the lives of patients with neurological and
psychiatric disorders. We are committed to the development of drugs
that improve lives by applying our extensive knowledge and
experience in central nervous system disorders. In addition to
CERC-501, Cerecor is currently pursuing the development of
CERC-301, which is also a clinical Phase 2-stage product
candidate.
CERC-301 is an oral, NR2B specific N-methyl-D-aspartate receptor
antagonist that is currently in a Phase 2 clinical trial as an
oral, rapidly acting adjunctive treatment for patients with severe
major MDD who are failing to achieve an adequate response to their
current antidepressant treatment, with a rapid onset of effect. We
expect top-line data from this trial in the first half of 2017.
Cerecor received fast track designation by the United States Food
and Drug Administration in November 2013 for CERC-301 for the
treatment of MDD. We believe CERC-301 has the potential to be a
first-in-class medication that may significantly reduce depressive
symptoms in a matter of days.
Cerecor has one preclinical stage asset, CERC-406, a brain
penetrant catechol-O-methyltransferase inhibitor with potential
procognitive activity.
For more information about the Company and its products, please
visit www.cerecor.com or contact Mariam E. Morris,
Chief Financial Officer, at (443) 304-8002.
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,”
“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,
technology enhancements, possible changes in legislation, 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 those
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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20160906005368/en/
MacDougall Biomedical CommunicationsDoug MacDougall or Joe
Rayne, 781-235-3060ir@cerecor.com
Cerecor (NASDAQ:CERC)
Historical Stock Chart
From Jun 2024 to Jul 2024
Cerecor (NASDAQ:CERC)
Historical Stock Chart
From Jul 2023 to Jul 2024