For the treatment of Central Nervous System Disorders
Azevan Pharmaceuticals is a clinical stage, small molecule drug development company developing novel therapeutics to treat stress-related CNS disorders and neurodegenerative conditions. The Company’s first clinical compounds selectively block the effects of arginine vasopressin, a peptide neurohormone involved in the pathophysiology of multiple disorders, including neuropsychiatric symptoms in neurodegenerative diseases, Intermittent Explosive Disorder, and PTSD. Vasopressin also is a key early signal in the neurological damage seen in traumatic brain injury and stroke. Vasopressin 1a receptor antagonists represent a novel mechanism of action for addressing these indications.
The Company completed two Phase II clinical trials in adults with its lead compound, SRX246, for the treatment of Intermittent Explosive Disorder and for the treatment of irritability of Huntington’s Disease Patients (the STAIR trial). The primary endpoints and exploratory goals of both trials were achieved. An additional Phase II clinical trial is in progress for the treatment of PTSD.
MarketsCNS, Stress, Mood, and Behavioral Disorders
Intermittent Explosive Disorder
severely impacts quality of life and poses substantial risk to patients. Current estimates indicate 5% lifetime prevalence in the US alone. There are no approved treatments.
Neuropsychiatric Symptoms in Huntington’s Disease.
Irritability, anger, and aggression are commonly observed in a high percentage of HD patients. These neuropsychiatric manifestations of HD are the leading cause of institutionalization of patients and significantly impact families and caregivers. Existing pharmacologic approaches are off label, have been ineffective, and carry side effect risks. There are no approved treatments.
Post-Traumatic Stress Disorder (PTSD)
The most rapidly growing psychiatric diagnosis in the United States, it is also a major issue for military medicine. Current treatments are repurposed antidepressant drugs that are minimally effective.
Traumatic Brain Injury (TBI)
The leading cause of death and disability in adults under 35 and the elderly, TBI is a growing global problem and there are no approved drug treatments. Vasopressin antagonists are a novel mechanism for preventing or reducing the cerebral edema that underlies the poor prognosis and outcomes in TBI.
The National Institute of Neurological Diseases and Stroke awarded the Company a major grant to conduct a Phase II trial with SRX246 in Huntington's Disease patients exhibiting irritability, a major neuropsychiatric symptom. The trial was conducted and completed in collaboration with the NINDS NeuroNext network across 22 sites nationwide. The primary and secondary endpoints were met and the exploratory efficacy endpoints demonstrated clinical benefit as well. As a result SRX246 was granted an Orphan Designation.
Intermittent Explosive Disorder Phase II Clinical Trial
A Phase II clinical trial with SRX246 for the treatment of Intermittent Explosive Disorder has been completed. The results showed excellent tolerability and safety with clinical benefit observed on multiple scales.
The Department of Defense awarded the Company a grant to conduct a Phase II trial with SRX246 for the treatment of PTSD. The trial is in progress in collaboration with Weill Cornell Medical College.