Cerecor’s Phase II clinical trial of CERC-301 to treat MDD fails to meet primary endpoint


US-based clinical-stage biopharmaceutical company Cerecor has reported that its Phase II clinical trial of CERC-301 to treat major depressive disorder (MDD) has failed to meet its primary endpoint.

CERC-301 is an orally administered, NR2B selective, NMDA receptor antagonist currently being developed as an adjunctive treatment of MDD.

It is expected to act as a first-in-class medication to significantly reduce depressive symptoms.

The randomised, double-blind, placebo-controlled, sequential parallel comparison design (SPCD) Phase II study, conducted for three weeks, assessed intermittent doses of adjunctive CERC-301 and placebo in treating 115 MDD patients who are not substantially responsive to anti-depressant therapy.

"While the trial failed to achieve the primary efficacy endpoint, we note that these results suggest a potentially clinically meaningful treatment effect in the 20mg dose at Day 2."

Subjects who were non-responsive to placebo in Period 1 were re-randomised to receive either study drug or placebo in Period 2, after which the results of Periods 1 and 2 were averaged.

Cerecor regulatory affairs head and chief medical officer Ronald Marcus said: "While the trial failed to achieve the primary efficacy endpoint, we note that these results suggest a potentially clinically meaningful treatment effect in the 20mg dose at Day 2.”

Results did not suggest any significant improvement in the condition of the patients when compared with placebo signifying the failure of the study to meet its primary endpoints.

However, CERC-301 has demonstrated tolerability consistent with the previously held clinical trials.

Cerecor president and CEO Dr Uli Hacksell said: "We intend to more fully assess the results from this trial as we continue to receive the remaining data sets over the coming weeks and will announce planned next steps for CERC-301 at a later time."