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Cerecor Inc. Receives Fast Track Designation For CERC-301 For The Treatment Of Major Depressive Disorder


11/25/2013 12:35:12 PM

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Baltimore, MD, November 25, 2013 – Cerecor Inc., a clinical stage biopharmaceutical company developing prescription pharmaceuticals that work in the human nervous system and which address the needs of underserved patient segments of major diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s lead clinical product candidate, CERC-301, for major depressive disorder (MDD). CERC-301 is a once daily, oral, adjunctive, selective NMDA receptor subunit 2B (NR2B) antagonist with the potential to be the first in a new class of rapidly acting antidepressants. The FDA’s Fast Track Drug Development Program is designed to facilitate the clinical development and expedite the review of drugs intended to treat a serious or life-threatening condition which demonstrate the potential to address an unmet medical need.

Cerecor recently announced the initiation of a Phase 2 clinical study of CERC-301 as an adjunctive treatment for subjects with MDD who have not adequately responded to their current therapy and report recent suicidal ideation.

“Fast Track designation for CERC-301 underscores the unmet need for rapid-acting antidepressants for patients who are not adequately responding to their current therapies,” said Blake M. Paterson, Co-founder & CEO of Cerecor. “Through its potential effect on the NR2B subunit, our Phase 2 study is designed to establish that CERC-301 provides rapid antidepressant effects without many of the current treatment limitations, including the psychotropic effects seen with broad NMDA channel blockers such as ketamine. A pilot study recently published by the National Institute of Mental Health suggested that oral CERC-301 provides rapid antidepressant effects, and we hope to confirm these results in the larger, fully powered Phase 2 study that is now underway.”

About CERC-301

CERC-301 is a novel and selective antagonist of the NMDA receptor subunit 2B. 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. Cerecor is conducting a 135 patient, placebo-controlled Phase 2 study of CERC-301 in this indication with results expected by year-end 2014.

About Cerecor

Cerecor Inc. is a privately held clinical stage biopharmaceutical company developing prescription pharmaceuticals that work in the human nervous system and which address the needs of underserved patient segments of major diseases. 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

Cautionary Note Regarding Forward-Looking Statements

This press release contains "forward-looking statements." All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to the potential benefits and safety of CERC-301. Forward-looking statements are based upon management's current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results and events to differ materially from those indicated herein including, among others, risks and uncertainties relating to the completion and outcome of clinical trials. While Cerecor may update certain forward-looking statements from time to time, it specifically disclaims any obligation to do so, whether as a result of new information, future developments or otherwise. You are cautioned not to place undue reliance on any forward-looking statements.

Contact

MacDougall Biomedical Communications

Michelle Avery, 781.235.3060, mavery@macbiocom.com, or

Christine Labaree, 650.339.7533, clabaree@macbiocom.com

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