Cerecor Inc. Announces Initiation of Second CERC-501 Phase 2 Clinical Trial in Smokers
August 29 2016 - 9:10AM
Business Wire
Study to evaluate the effect of CERC-501 on
stress-related smoking lapse
Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company
developing innovative drugs that have the potential to make a
difference in the lives of patients with neurological and
psychiatric disorders, today announced that Dr. Sherry McKee from
Yale University has enrolled the first subject in the Phase 2
clinical trial for CERC-501, “Does CERC-501 Attenuate
Stress-Related Smoking Lapse?” The study is a collaborative effort
between Cerecor and Dr. McKee and is supported by funding from the
National Institutes of Health (NIH). “Stress is a primary
contributor to the maintenance of, and relapse to, smoking, and
targeting stress-related relapse as a medication development
strategy is a critical, yet relatively unexplored area of
research,” says Dr. McKee. "Preclinical findings suggest that the
kappa opioid receptor system is involved in stress-induced relapse
to tobacco and we anticipate that a receptor antagonist, such as
CERC-501, has the potential to be of therapeutic benefit.”
The primary objective of the double-blind, placebo-controlled,
crossover study is to evaluate whether CERC-501, compared to
placebo, will increase the ability to resist smoking, and reduce
subsequent smoking following overnight nicotine deprivation and
personalized stress imagery in subjects who are heavy smokers. “We
are enthusiastic about the potential use of CERC-501 for addictive
disorders, including smoking cessation,” said Dr. Ronald N. Marcus,
Chief Medical Officer and Head of Regulatory Affairs at
Cerecor.
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 in animal models.
CERC-501 has been observed to have positive preclinical activity in
models of depression, nicotine withdrawal and alcohol dependence,
and it has been generally well tolerated in three human clinical
trials. Cerecor is currently studying the effect of CERC-501 on
nicotine withdrawal in a Phase 2 study that is anticipated to
provide top-line data in the fourth quarter of 2016 (the study is
being supported by a grant from the National Institute on Drug
Abuse at the NIH). In addition, the National Institute on Alcohol
Abuse and Alcoholism at the NIH is funding an ongoing clinical
trial for CERC-501 on depressive symptoms across mood and anxiety
spectrum disorders. A private foundation is providing support for
the ongoing clinical study of CERC-501 in cocaine addiction
conducted at the Rockefeller University Hospital. Cerecor is
planning to initiate a Phase 2 study with CERC-501 as an adjunctive
treatment of MDD in the first half of 2017.
About CerecorCerecor is a biopharmaceutical company that
is developing innovative drugs that make a difference in the lives
of patients with neurological and psychiatric diseases. Cerecor is
currently pursuing the development of two clinical Phase 2-stage
product candidates: CERC-501 and CERC-301, an oral, NR2B-specific,
NMDA receptor antagonist. Cerecor is currently conducting a Phase 2
study of CERC-301 as an adjunctive treatment of MDD and expects to
announce results from that study in the first half of 2017. In
addition, Cerecor is conducting preclinical testing of CERC-406, a
brain penetrant COMT 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 include
statements regarding potential benefits and uses of Cerecor’s
product candidates, statements about the timing of expected trial
results and other statements with respect to Cerecor’s plans,
objectives, projections, expectations and intentions, including
statements identified by words such as “projects,” “may,” “will,”
“could,” “would,” “should,” “believes,” “expects,” “anticipates,”
“estimates,” “intends,” “plans,” “potential” or similar
expressions. 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/20160829005070/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