PH94B for Adjustment Disorder with Anxiety

Almost everyone experiences significant life events, changes, or stressors from time to time, and while some individuals adjust to such changes within a few months, others cannot and may experience adjustment disorder. Adjustment disorder with anxiety (AjDA) is the development of emotional or behavioral symptoms considered excessive or disproportionate in response to a sudden change, stressful event or circumstance, or other identifiable anxiety-provoking stressor, such as loss of work, a divorce or a health setback, significantly impairing a person’s social, occupational and/or other important area(s) of functioning. The stress-related disturbance does not represent normal bereavement or meet the criteria for another mental disorder and is not merely an exacerbation of a preexisting mental disorder.

The mental health stressors associated with the COVID-19 pandemic have directly or indirectly affected hundreds of millions of individuals around the world and have considerably increased the prevalence of AjDA. We believe the mental health impact of the COVID-19 pandemic will be long-term and varied across a wide range of anxiety disorders. PH94B has potential as a novel, treatment of anxiety for adults with AjDA, including stress and impaired functioning as a result of recent-onset of stressors brought on by the health, safety, economic and social circumstances, including, but not limited to, circumstances related to and consequences of the COVID-19 pandemic and civil unrest.

With successful Phase 2 development of PH94B for acute treatment of anxiety in adults with Social Anxiety Disorder (SAD) completed and Phase 3 development for that indication now underway, we initiated our exploratory Phase 2A clinical program of PH94B for additional anxiety disorders, with the first Phase 2A trial in AjDA. The exploratory Phase 2A clinical trial of PH94B in AjDA is a randomized, double-blind, placebo-controlled study with an enrollment target of approximately 40 adults at clinical sites in the Boston and New York City metro areas. Dr. Michael Liebowitz, a Columbia University psychiatrist, former director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute, and director of the Medical Research Network in New York City is serving as Principal Investigator of the trial. The study’s primary outcome measure is the change from baseline in anxiety level as measured by the Hamilton Anxiety Rating Scale (HAM-A). Additional details about the clinical trial can be found at www.clinicaltrials.gov, identifier NCT04404192.