BETHLEHEM, Pa., Sept. 14, 2016 /PRNewswire/ -- Azevan Pharmaceuticals, Inc. (www.azevan.com) announced results from the phase 2 exploratory clinical study of the Company's lead compound, SRX246, in adults with Intermittent Explosive Disorder. The study was a multi-center, randomized, double blind, placebo controlled trial in 97 adult male and female subjects. It included a two-week placebo lead-in phase and then randomization to SRX246 or placebo for 8 weeks.
The primary endpoint and exploratory goals of the trial were achieved. SRX246 was generally well tolerated and no serious adverse events were reported. Adverse events were mild, transient, and not dose-dependent. The exploratory analysis revealed statistically significant differences favoring SRX246 in key outcome measures that indicate clinical benefit.
"This was a first-in-patient, dose escalation phase 2 exploratory study with a novel compound in an indication where there is no approved treatment," said Dr. Neal Simon, CEO. "The results provide a path forward for the development of SRX246 for the treatment of Intermittent Explosive Disorder."
"The Company's development program for SRX246 is focused on psychiatric indications where there is high unmet need," added Dr. Simon. "In addition to this trial, Azevan has an ongoing phase 2 trial with SRX246 for the treatment of irritability in Huntington's Disease patients and a soon to be launched phase 2 trial for the treatment of Post Traumatic Stress Disorder."
About Intermittent Explosive Disorder
Intermittent Explosive Disorder is characterized by recurrent, problematic, impulsive aggression. Episodes involve physical assault, verbal assault, property assault, and commonly occur in response to a minor provocation. Substantial distress, impairment in social functioning, occupational difficulty, and legal or financial problems are associated with these episodes. Intermittent Explosive Disorder affects about 5-7% of the US population.
SRX246 is a first-in-class, orally bioavailable, CNS-penetrating Vasopressin1a (V1a) receptor antagonist that exhibits exceptional affinity and selectivity for the target receptor. In preclinical studies, SRX246 showed efficacy in models of fear, aggression, depression, and anxiety, including neuroimaging investigations. SRX246 has demonstrated excellent safety and is well tolerated in human subjects. In an experimental medicine fMRI study, it had robust effects on CNS circuits that are dysregulated in stress-related affective disorders. The compound exhibits promise as a breakthrough treatment for disorders of stress, mood, and behavior that impact millions of people worldwide.
About Azevan Pharmaceuticals, Inc.
Azevan Pharmaceuticals is a privately held, clinical stage, small molecule drug development company headquartered in Bethlehem, Pennsylvania. The Company develops new therapeutics to treat disorders of stress, mood, and behavior where there is high unmet need. Azevan's first clinical compounds selectively block the effects of arginine vasopressin, a peptide neurohormone involved in the pathophysiology of multiple psychiatric indications.
SOURCE Azevan Pharmaceuticals, Inc.