Cerecor says CERC-301 misses primary endpoint
Cerecor announced top-line clinical results from its major depressive disorder, MDD, Phase 2 clinical trial of adjunctive treatment of CERC-301, an oral, NR2B specific, NMDA receptor antagonist. Overall, the trial failed to demonstrate efficacy on the primary endpoint for mean improvement in Bech-6, a subset of the Hamilton Depression Scale, averaged over days 2 and 4 post dose. However, the study showed signals for the CERC-301 20 mg dose group at Day 2, at pre-specified secondary endpoints, indicating a potentially clinically-meaningful effect, though not statistically significant, on the Bech-6 and HDRS-17. The trial was a 3-week randomized, double-blind, placebo-controlled, sequential parallel comparison design study of intermittent doses of adjunctive CERC-301 or placebo in the treatment of subjects with MDD who have not adequately responded to antidepressant therapy, either a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine uptake inhibitor. The study randomized 115 subjects. The study was conducted in two sequential one week periods. 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 Periods 1 and 2 were averaged. The study included a one-week follow-up.