Azevan Pharmaceuticals Completes Enrollment In Phase 2 Clinical Study Of SRX246 In Intermittent Explosive Disorder

BETHLEHEM, Pa., May 9, 2016 /PRNewswire/ -- Azevan Pharmaceuticals, Inc. (www.azevan.com), which is developing novel small molecule medicines for disorders of stress, mood, and behavior, announced that enrollment has been completed in a Phase 2 clinical study of the company's lead compound SRX246 in adults with DSM-5 Intermittent Explosive Disorder.

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"SRX246 is an oral, first-in-class vasopressin 1a receptor antagonist. Targeting this receptor, which is widely distributed throughout the brain, represents a new mechanism of action for the treatment of Intermittent Explosive Disorder, as well as other psychiatric indications," said Dr. Michael Brownstein, Vice President for Drug Development. "The trial was designed to evaluate the safety, tolerability, and activity of SRX246 in patients using several established clinical measures," added Dr. Brownstein. "We expect to report results of this trial in the second quarter."

The study is a randomized, double-blind, placebo-controlled, dose escalation design, being conducted at 7 centers in the US. After randomization, patients received either placebo or 120 mg SRX246 twice a day (bid) for four weeks and, following a safety assessment, escalated to 160 mg bid for an additional four weeks.  The effect of SRX246 on key measures of Intermittent Explosive Disorder including irritability, anger and aggression, is being examined using a variety of measures, including the Overt Aggression Scale-Modified (OAS-M) and State-Trait Anger Expression Inventory (STAXI), among others.  The findings with SRX246 across these measures as well as those reflecting safety and tolerability will guide selection of Food and Drug Administration (FDA)-accepted efficacy endpoints for future clinical trials.

There are no approved medications for the treatment of Intermittent Explosive Disorder, which affects approximately 16 million people in the US.  To learn more about Azevan's Phase 2 study with SRX246 in Intermittent Explosive Disorder, please see clinicaltrials.gov (NCT02055638).

About Azevan Pharmaceuticals, Inc.

Azevan Pharmaceuticals is a privately held, clinical stage, small molecule drug development company developing novel therapeutics to treat disorders of stress, mood, and behavior headquartered in Bethlehem, Pennsylvania. The Company is developing new molecules that address significant unmet needs in psychiatry through a novel mechanism of action. Azevan's first clinical compounds selectively block the effects of arginine vasopressin, a peptide neurohormone, involved in the pathophysiology of Intermittent Explosive Disorder, neuropsychiatric symptoms in Huntington's Disease, and PTSD.

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SOURCE Azevan Pharmaceuticals, Inc.

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