BALTIMORE--(BUSINESS WIRE)--Cerecor Inc., a clinical-stage biopharmaceutical company developing treatments to make a difference in the lives of patients with neurological and psychiatric disorders, today announced the results of an exploratory inpatient pharmacokinetic / pharmacodynamic (PK/PD) study and the results of a Phase 2 outpatient efficacy study of CERC-301 for the adjunctive treatment of patients with major depressive disorder (MDD), who had recently experienced suicidal ideation. The PK/PD study provided evidence of safety and tolerability at daily doses up to 20mg, providing the basis for future efficacy studies at doses greater than 8mg. In the Phase 2 study, CERC-301 was administered daily at a dose of 8mg for 28 days and did not meet its primary endpoint of a change in the Hamilton Depression Rating Scale at day 7. CERC-301 is an oral, selective NMDA receptor subunit (NR2B) antagonist, which is thought to provide a rapid onset of antidepressant effect without the undesirable intoxication and hallucinations of non-selective NMDA receptor antagonists. In both studies, CERC-301 was well-tolerated and did not induce these untoward effects.
“The goal of our Phase 2 efficacy study was to recapitulate the results seen in an NIMH pilot study, and while we did not meet that objective, we are encouraged by the safety and tolerability profile at higher doses as seen in our PK/PD trial and believe that the potential of CERC-301 may be optimized with a higher dosing regimen,” said Blake M. Paterson, M.D., Co-founder & CEO of Cerecor. “We look forward to initiating a revised dose Phase 2 study in the second half of this year and bringing a much-needed option to patients, who are not adequately served with their current antidepressants.”
The 135 patient, placebo-controlled Phase 2 study was designed to assess CERC-301 as adjunctive treatment for patients with MDD, who had failed to adequately respond to current selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) treatment, had recent active suicidal ideation, and were deemed appropriate for an out-patient study. The safety and efficacy of 8mg of CERC-301 per day were evaluated over 28 days of treatment, with the primary endpoint of the change in the Hamilton Depression Rating Scale at day 7. In the PK/PD study, 48 patients were enrolled, and CERC-301 was well-tolerated at doses up to 20mg per day. Full results from the studies will be presented at an upcoming medical conference.
Cerecor plans to initiate the next Phase 2 efficacy study, evaluating a higher dose and revised dosing regimen of CERC-301 in the second half of 2015.
Cerecor Inc. (“Cerecor”) is a Baltimore-based biopharmaceutical company developing proprietary treatments to make a difference in the lives of patients with neurological and psychiatric diseases by addressing the unmet medical needs of underserved patient segments. We are committed to the development of drugs that improve lives by applying our extensive knowledge and experience in central nervous system disorders. www.cerecor.com