Cerecor Initiates Phase 2 Study for CERC-301, an Antidepressant Product Candidate With Potential for Rapid Onset of Effect

BALTIMORE, Md.--()--Cerecor Inc., a clinical-stage biopharmaceutical company with the goal of becoming a leader in the development of innovative drugs that make a difference in the lives of patients with neurological and psychiatric disorders, today announced that it has dosed the first subject in Clin301-203, a Phase 2 study of CERC-301 as an oral, adjunctive treatment of major depressive disorder (MDD). CERC-301 is an NR2B specific, NMDA antagonist, which the Company believes has the potential to provide a rapid onset of antidepressant effect.

“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,” said Blake M. Paterson, MD, Co-founder and CEO of Cerecor. “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.”

Clin301-203 is a randomized, double blinded placebo-controlled trial designed to evaluate the antidepressant effect of 12 mg and 20 mg doses of CERC-301. The trial is expected to enroll approximately 104 subjects with MDD who are currently experiencing a severe depressive episode despite stable ongoing treatment with either a serotonin reuptake inhibitor, or SSRI, or serotonin norepinephrine reuptake inhibitor, or SNRI. Clin301-203 includes two intermittent dose administrations seven days apart, followed by 14 days of observation. The primary objective of Clin301-203 is to evaluate the antidepressant effect of CERC-301, in 12 mg and 20 mg dosages, compared to placebo as assessed by the 6-item unidimensional sub-set of the Hamilton Depression Rating Scale.

About Cerecor

Cerecor Inc (“Cerecor”) is a Baltimore-based biopharmaceutical company with the goal of becoming a leader in the development of innovative drugs that 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

Forward-looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding our prospects, plans and objectives of management, are forward-looking statements. The words “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

The forward-looking statements in this press release include, among other things, statements about:

  • Our plans to complete research and clinical development of current and future product candidates; and
  • Our ongoing and planned preclinical studies and clinical trials;

We may not actually achieve the plans, intentions or expectations described in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations described in the forward-looking statements we make. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified timeframe, or at all.

Contacts

MacDougall Biomedical Communications
Michelle Avery, 781-235-3060
mavery@macbiocom.com

Release Summary

Cerecor initiates Phase 2 study of CERC-301 as oral, adjunctive treatment of major depressive disorder. CERC-301 has the potential to provide a rapid onset of antidepressant effect.

Contacts

MacDougall Biomedical Communications
Michelle Avery, 781-235-3060
mavery@macbiocom.com