Cerecor Reports Encouraging Topline Data from a NIH Sponsored Proof-of-Concept Trial of CERC-501 in Treatment-Resistant Depression
2017-05-01 08:30 ET - News Release
Cerecor Reports Encouraging Topline Data from a NIH Sponsored Proof-of-Concept Trial of CERC-501 in Treatment-Resistant Depression
Clinically Meaningful Improvements Observed at Day 3
BALTIMORE, MD--(Marketwired - May 01, 2017) - 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 topline clinical results from a small, proof-of-concept clinical trial sponsored by the National Institute of Mental Health ("NIMH") of the National Institutes of Health. This was a Phase 2 trial of CERC-501, a potent and selective oral kappa opioid receptor ("KOR") antagonist, in treatment resistant depression ("TRD") conducted under the leadership of Dr. Maurizio Fava of Massachusetts General Hospital ("MGH").
In this sequential parallel comparison design ("SPCD") trial entitled, Proof of Concept Trial of CERC-501 Augmentation of Antidepressants Therapy in Treatment Resistant Depression, CERC-501 showed a clinically meaningful 2.0-point difference from placebo on the Hamilton Rating Scale for Depression - 6 - items ("HAM-D-6"), change from baseline to 72 hours, which served as the primary efficacy measure. A 2.0-point difference between CERC-501 and placebo on the HAM-D-6 is comparable to a 4.0-point difference on the Hamilton Depression Rating Scale-17 (HDRS-17). Clinically meaningful differences were also observed across multiple, pre-specified, secondary outcome measures:
Number of Responders (50% or greater reduction) on the HAM-D-6 at 72 hours
Change in Montgomery-Asberg Depression Rating Scale ("MADRS")
Change in the Perceived Stress Scale ("PSS")
Change in Clinical Global Impression Severity ("CGI-S")
Clinical Global Impression Improvement ("CGI-I") Score
Change in Symptoms of Depression Questionnaire ("SDQ")
Change in Positive Affect Scale ("PAS")
"These results provide additional support for the development of CERC-501 as an adjunctive treatment of major depressive disorder ('MDD')," said Uli Hacksell, Ph.D., Chief Executive Officer and Chairman of Cerecor. "We want to thank the NIMH for supporting the trial."
The trial was a randomized, double-blind, placebo-controlled, SPCD designed study in subjects with treatment resistant depression on stable antidepressant therapy. Subjects participated in two sequential 72 hour periods and received CERC-501 (10 mg or 20 mg) or placebo. Placebo non-responders in Period 1 were re-randomized to either study drug or placebo in Period 2. Subjects received treatment at the beginning of each period. The results of Period 1 and 2 were averaged. The five-site trial was terminated early due to recruitment issues and eight subjects in total were randomized. Statistical testing was not performed due to the early termination and small sample size.
CERC-501 was generally well-tolerated with no serious adverse events reported and no discontinuations due to adverse events with CERC-501.
"The performance of CERC-501 in this Phase 2 proof-of-concept study is consistent with our original expectations when we designed the study," said Maurizio Fava, MD, Director of the Division of Clinical Research and Executive Vice Chair, Department of Psychiatry at MGH, and the principle investigator of the trial. "The results on the Perceived Stress Scale showed changes that have not historically been seen in only 3 days of treatment with standard antidepressants. In this experiment, at Day 3, subjects treated with adjunctive CERC-501 had a 3.5 point decrease from baseline while placebo treated patients had a 0.5-point increase in the Perceived Stress Scale."
Analysis of the data set is ongoing and will be presented by the study investigators at a future scientific conference in 2017.
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