CLINICAL CANDIDATES

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 CNS disorders. Psychiatric indications of interest include neuropsychiatric symptoms in neurodegenerative diseases such as Huntington’s Disease and Alzheimer’s Disease, Intermittent Explosive Disorder, and PTSD. In the U.S. alone, these disorders affect more than 40 million people. Recent preclinical findings demonstrated the potential utility of V1a receptor antagonism as a new approach for the treatment of Traumatic Brain Injury (TBI) and other indications where cerebral edema is a major contributor to mortality and morbidity.

Both SRX246 and SRX251 reduce measures of stress, fear, aggression, depression, and anxiety in preclinical models, including neuroimaging investigations. A translational human Experimental Medicine fMRI study confirmed robust CNS effects after oral dosing in circuits that are dysregulated in stress-related disorders. In a moderate TBI model, the Company’s V1a antagonists significantly reduced edema and eliminated cognitive deficits seen in concussed-untreated animals. This unique combination of properties demonstrates exceptional promise for vasopressin antagonists as a novel approach to treating CNS disorders. The development of these compounds has been supported by the National Institutes of Health through multiple SBIR grants, the National Toxicology Evaluation Program, the RAID Program, the NINDS NeuroNext program; a grant from the Dept. of Defense; and private venture capital.

SRX246 completed a Phase II clinical trial for the treatment of Intermittent Explosive Disorder that achieved its primary endpoint and exploratory goals. SRX246 was generally well tolerated, no serious adverse events were reported, and clinical benefit was observed on multiple scales. Additional Phase II clinical trials for the treatment of Huntington’s Disease patients with irritability and for the treatment of PTSD are in progress. Results for treating irritability in Huntington’s Disease patients are expected in Q1 2019.

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