PH94B for Post-traumatic Stress Disorder (PTSD)

Post-traumatic stress disorder (PTSD) is a clinically diagnosed psychiatric disorder that develops in some people who have experienced or witnessed a shocking, scary, dangerous or life-threatening event, such as military combat, natural disasters, terrorist incidents, serious accidents, or physical or sexual assault in adulthood or childhood. Symptoms of PTSD include flashbacks, nightmares, severe anxiety, uncontrollable intrusive thoughts, and emotional numbing after the event. More than 8 million people in the U.S. suffer from PTSD. Anyone can develop PTSD at any age. According to the National Center for PTSD, about seven or eight out of every 100 people will experience PTSD at some point in their lives. The prevalence of PTSD is even higher in populations at risk for exposure to trauma, such as military service members and first responders. PTSD is often accompanied by depression or one or more of the other anxiety disorders, and PTSD sufferers also have a higher rate of suicide and often struggle with simultaneous addiction, leading to an even greater social and economic burden of the disorder.

It is natural to feel afraid during and after a traumatic situation. Fear triggers many split-second changes in the body to help defend against danger or to avoid it. This “fight-or-flight” response is a typical reaction meant to protect a person from harm. Because PTSD is associated with a heightened “fight or flight” response mediated by increased sympathetic nervous response to conditioned stimuli, an agent which decreases sympathetic tone may be able to treat some symptoms of PTSD. In Phase 2 studies, at microgram doses, PH94B has been shown to have rapid-onset anti-anxiety effects in patients with both generalized anxiety disorder (GAD) and SAD. PH94B may therefore have utility as an as-needed, rapid-onset treatment of symptoms of PTSD. Available therapeutic options for PTSD are limited, including only two FDA-approved antidepressants, which have limited efficacy and undesirable side effects.

In collaboration with clinical investigators at leading university medical centers in the U.S., we are exploring opportunities for exploratory Phase 2A clinical development of PH94B as a potential as-needed, on-demand, fast-acting anxiolytic in the PTSD treatment paradigm.

  1. U.S. Department of Veterans Affairs, https://www.ptsd.va.gov/understand/common/common_adults.asp