The Company’s lead clinical candidates, SRX246 and SRX251, are first-in-class, CNS-penetrating, high affinity, high selectivity V1a receptor antagonists that are orally bioavailable. These compounds represent a potential breakthrough approach for the treatment of stress-related affective disorders and neuropsychiatric symptoms in neurodegenerative diseases.
SRX246 and SRX251 are being developed as novel therapeutics for unmet needs in major markets. Target indications are the treatment of irritability, anger, and aggression in Huntington’s Disease, PTSD, and Intermittent Explosive Disorder. Additional indications of interest are Major Depression, including Treatment Resistant Depression, and Anger/Aggression/Impulse Control Disorders that are commonly seen in TBI and ADHD. Pre-clinical and human Experimental Medicine fMRI studies with these compounds were supported by the National Institutes of Health through multiple SBIR grants, the National Toxicology Evaluation Program, and the RAID Program.. In the U.S. alone, these disorders affect more than 40 million people and pharmaceutical treatments represent an estimated $25 billion annual market.
Successful Phase I Clinical Trials with SRX246 and SRX251 have established safety and tolerability though single- and multiple ascending repeat dose studies. SRX246 has completed 13-week toxicology studies in two species and is ready for Phase II Clinical Trials.
Both SRX246 and SRX251 reduce measures of stress, fear, aggression, depression, and anxiety in preclinical models, including neuroimaging investigations. A translational human Experimental Medicine study confirmed robust CNS effects after oral dosing in circuits that are dysregulated in stress-related disorders Azevan believes that this unique combination of properties demonstrates exceptional promise for vasopressin antagonists as a novel approach to treating disorders of stress, mood, and behavior.