Cerecor Announces $1.0 Million Research & Development Grant from the National Institute on Alcohol Abuse
and Alcoholism at the National Institutes of Health
Grant to Fund CERC-501 Development for Alcohol Use Disorder
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 been awarded a grant (award number
U44AA025253) from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) at the National Institutes of Health (NIH). The
grant of $1.0 million provides Cerecor with additional resources to progress the development of CERC-501 for the treatment of
alcohol use disorder (AUD). Upon successful completion of the development activities covered under this grant, Cerecor will have
the opportunity to apply for continued funding.
CERC-501 is a potent and selective kappa opioid receptor (KOR) antagonist. KORs are believed to play key roles in modulating
stress, mood and addictive behaviors. Both KORs and dynorphin, which together comprise the kappa opioid system, are upregulated by
stress and chronic exposure to drugs of abuse, and are thought to mediate the negative emotional states seen in substance
withdrawal and contribute to stress-induced reinstatement of substance seeking behavior.
According to the NIAAA more than 16 million Americans have an AUD, almost 90,000 people die annually due to alcohol related
causes, and the economic burden of AUD is approaching $250 million per year. “Current medical and psychosocial treatments are
clearly inadequate to address this significant health issue,” said Dr. Ronald N. Marcus, Chief Medical Officer and Head of
Regulatory Affairs at Cerecor. “We believe CERC-501 offers a unique approach to address the unmet needs in patients suffering from
AUD.”
“We are most appreciative to yet another NIH organization for augmenting our own efforts in the development of CERC-501 for
substance use disorders,” said Dr. Uli Hacksell, Cerecor’s Chief Executive Officer, President and Chairman. “This grant from the
NIAAA will enable us to pursue development in AUD, whilst the previously-communicated National Institute on Drug Abuse grant is
co-funding Clin501-201, an on-going Phase 2 study of CERC-501 in smoking cessation. We believe both NIH grants validate the
potential importance and scientific strength of the CERC-501 program.”
About CERC-501
CERC-501 is a potent and selective oral KOR antagonist being developed to treat substance use disorders and for 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. An ongoing Phase 2 smoking cessation
trial with CERC-501 is expected to provide top-line data in the fourth quarter of 2016.
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 other 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.
MacDougall Biomedical Communications
Doug MacDougall or Joe Rayne, 781-235-3060
ir@cerecor.com
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