BALTIMORE--(BUSINESS WIRE)--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-501
CERC-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 Cerecor
Cerecor 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 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 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.
