US-based biopharmaceutical firm Cerecor has started dosing in Clin301-203, a Phase II trial of an antidepressant product candidate CERC-301 to treat major depressive disorder (MDD).
CERC-301 is an NR2B specific, N-methyl-D-aspartate (NMDA) antagonist, which is believed to have the potential to provide a rapid onset of antidepressant effect.
The company is mainly focused on developing new drugs for patients with neurological and psychiatric disorders.
The randomised, double-blinded, placebo-controlled Phase II trial will evaluate the antidepressant effect of 12mg and 20mg doses of CERC-301.
Approximately 104 subjects with MDD, who are currently experiencing a severe depressive episode despite stable ongoing treatment with either a serotonin reuptake inhibitor (SSRI), or serotonin norepinephrine reuptake inhibitor (SNRI), will be enrolled in the trial.
Cerecor co-founder and CEO Blake Paterson said: "Ketamine has recently attracted interest for its rapid antidepressant effect in multiple clinical studies, however, its adverse side effect profile and requirement for physician administration have stymied its development for treatment-resistant MDD.
"Although CERC-301’s mechanism of action is based on ketamine, it is orally administered, has the potential to minimize side effects through its selectivity for NR2B, and provides a therapeutic option for patients with depression who are not responding to standard treatments."
The Phase II Clin301-203 trial includes two intermittent dose administrations seven days apart, followed by 14 days of observation.
The trial’s primary objective is to evaluate the antidepressant effect of CERC-301, in 12mg and 20mg dosages, compared to placebo as evaluated by the six-item unidimensional sub-set of the Hamilton Depression Rating Scale.