BALTIMORE, MD, USA I November 8, 2013 I Cerecor Inc., a biopharmaceutical company developing prescription pharmaceuticals that work in the human central nervous systems and which address needs of underserved patient segments of major diseases, today announced it has received IND clearance from the United Stated Food and Drug Agency to conduct a clinical trial for its investigational product candidate CERC-301. The Company has initiated a Phase 2 study of CERC-301, an oral, selective NMDA receptor subunit 2B (NR2B) antagonist for the adjunctive treatment of subjects with major depressive disorder (MDD) who have not adequately responded to their current therapy and report recent suicidal ideation. In a pilot study in five patients with treatment-resistant depression (TRD) conducted by the National Institute of Mental Health (NIMH), CERC-301 was well-tolerated and despite the small sample size, results suggested that an oral formulation of CERC-301 may have rapid antidepressant properties in TRD patients.
The 135 patient, placebo-controlled Phase 2 study is designed with input from a panel of clinical experts in the treatment of depression to assess CERC-301 as adjunctive treatment. The study population consists of MDD subjects who would likely benefit most from rapid onset antidepressant activity – those who are failing current selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) treatment, have had recent active suicidal ideation, and are deemed appropriate for an out-patient study with careful safety surveillance. The safety and efficacy of CERC-301 will be evaluated over 28 days of treatment, and the primary endpoint is the change in the Hamilton Depression Rating Scale at day 7.
“Patients who experience severe depression, often with thoughts of suicide, have few options for treatment, most of which are the classic antidepressants that take four to eight weeks to become effective,” said Richard C. Shelton, M.D., the Charles B. Ireland Professor & Vice Chair for Research, University of Alabama at Birmingham, School of Medicine, and investigator in the study. “There is a clear need for a rapid-acting antidepressant for these patients who are not fully responding to their current therapy. The pilot study performed by the NIMH suggests that CERC-301 has the potential to provide rapid relief, in a fashion similar to clinical effects seen with other NMDA-receptor blockers.”
“The aim of the sequential parallel comparison design in the CERC-301 Phase 2 study is to overcome the challenges of placebo response frequently observed in depression trials,” added Maurizio Fava, M.D., Executive Vice Chair, Department of Psychiatry, Executive Director, MGH Clinical Trials Network & Institute, and Director, Depression Clinical & Research Program, Massachusetts General Hospital and advisor for the study design. “By allowing for the placebo non-responder population to be enriched and by using remote calibrated central raters, it is expected that placebo response can be mitigated and signal detection enhanced.”
“CERC-301 has the potential to make an impact for patients and families who struggle with these severe depressive episodes,” commented Blake M. Paterson, M.D., Co-founder & CEO of Cerecor. “We are excited to begin this trial, and we expect to receive results in the second half of 2014.”
About CERC-301
CERC-301 is a novel, potent and selective antagonist of the NMDA receptor subunit 2B (NR2B). It has the potential to be a first-in-class oral medication that is complimentary to existing treatments in patients with depression who have not adequately responded to their current therapy. These therapies are often limited by modest response rates, poor remission rates, slow onset of action and problematic side effects. In an exploratory proof-of-concept study published in 2012, CERC-301 demonstrated rapid antidepressant efficacy in patients with treatment resistant depression. Cerecor is conducting a 135 patient, placebo-controlled Phase 2 study of CERC-301 in this indication with results expected during the second half of 2014.
About Cerecor
Cerecor Inc. is a privately held biopharmaceutical company focused on the development and commercialization of prescription pharmaceuticals whose primary site of activity is in the human nervous system. The Company is developing first-in-class drugs where human proof-of-concept has been established for the target, the molecule, or both in conditions for which established biomarkers are available to facilitate development. Cerecor’s programs address the needs of underserved sub-segments of major diseases. Cerecor increases the probability of clinical success by employing specific trial methodologies that reduce placebo response rates and enhance efficacy signals. www.cerecor.com
SOURCE: Cerecor
Post Views: 86
BALTIMORE, MD, USA I November 8, 2013 I Cerecor Inc., a biopharmaceutical company developing prescription pharmaceuticals that work in the human central nervous systems and which address needs of underserved patient segments of major diseases, today announced it has received IND clearance from the United Stated Food and Drug Agency to conduct a clinical trial for its investigational product candidate CERC-301. The Company has initiated a Phase 2 study of CERC-301, an oral, selective NMDA receptor subunit 2B (NR2B) antagonist for the adjunctive treatment of subjects with major depressive disorder (MDD) who have not adequately responded to their current therapy and report recent suicidal ideation. In a pilot study in five patients with treatment-resistant depression (TRD) conducted by the National Institute of Mental Health (NIMH), CERC-301 was well-tolerated and despite the small sample size, results suggested that an oral formulation of CERC-301 may have rapid antidepressant properties in TRD patients.
The 135 patient, placebo-controlled Phase 2 study is designed with input from a panel of clinical experts in the treatment of depression to assess CERC-301 as adjunctive treatment. The study population consists of MDD subjects who would likely benefit most from rapid onset antidepressant activity – those who are failing current selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) treatment, have had recent active suicidal ideation, and are deemed appropriate for an out-patient study with careful safety surveillance. The safety and efficacy of CERC-301 will be evaluated over 28 days of treatment, and the primary endpoint is the change in the Hamilton Depression Rating Scale at day 7.
“Patients who experience severe depression, often with thoughts of suicide, have few options for treatment, most of which are the classic antidepressants that take four to eight weeks to become effective,” said Richard C. Shelton, M.D., the Charles B. Ireland Professor & Vice Chair for Research, University of Alabama at Birmingham, School of Medicine, and investigator in the study. “There is a clear need for a rapid-acting antidepressant for these patients who are not fully responding to their current therapy. The pilot study performed by the NIMH suggests that CERC-301 has the potential to provide rapid relief, in a fashion similar to clinical effects seen with other NMDA-receptor blockers.”
“The aim of the sequential parallel comparison design in the CERC-301 Phase 2 study is to overcome the challenges of placebo response frequently observed in depression trials,” added Maurizio Fava, M.D., Executive Vice Chair, Department of Psychiatry, Executive Director, MGH Clinical Trials Network & Institute, and Director, Depression Clinical & Research Program, Massachusetts General Hospital and advisor for the study design. “By allowing for the placebo non-responder population to be enriched and by using remote calibrated central raters, it is expected that placebo response can be mitigated and signal detection enhanced.”
“CERC-301 has the potential to make an impact for patients and families who struggle with these severe depressive episodes,” commented Blake M. Paterson, M.D., Co-founder & CEO of Cerecor. “We are excited to begin this trial, and we expect to receive results in the second half of 2014.”
About CERC-301
CERC-301 is a novel, potent and selective antagonist of the NMDA receptor subunit 2B (NR2B). It has the potential to be a first-in-class oral medication that is complimentary to existing treatments in patients with depression who have not adequately responded to their current therapy. These therapies are often limited by modest response rates, poor remission rates, slow onset of action and problematic side effects. In an exploratory proof-of-concept study published in 2012, CERC-301 demonstrated rapid antidepressant efficacy in patients with treatment resistant depression. Cerecor is conducting a 135 patient, placebo-controlled Phase 2 study of CERC-301 in this indication with results expected during the second half of 2014.
About Cerecor
Cerecor Inc. is a privately held biopharmaceutical company focused on the development and commercialization of prescription pharmaceuticals whose primary site of activity is in the human nervous system. The Company is developing first-in-class drugs where human proof-of-concept has been established for the target, the molecule, or both in conditions for which established biomarkers are available to facilitate development. Cerecor’s programs address the needs of underserved sub-segments of major diseases. Cerecor increases the probability of clinical success by employing specific trial methodologies that reduce placebo response rates and enhance efficacy signals. www.cerecor.com
SOURCE: Cerecor
Post Views: 86
