Cerecor (CERC) Enrolls Final Patient in CERC-501 Phase 2 for Smoking Cessation

September 6, 2016 9:18 AM EDT
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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.



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