VistaGen Therapeutics Inc (VTGN)

[JohnLocke101]

VistaGen Therapeutics Initiates PALISADE Phase 3 Trial of PH94B in Social Anxiety Disorder

PALISADE Phase 3 Program focused on acute treatment of anxiety in adults with Social Anxiety Disorder

FDA Fast Track designation granted

Topline results anticipated in mid-2022

VistaGen Therapeutics Inc. (NASDAQ: VTGN), a biopharmaceutical company committed to developing a new generation of medicines with the potential to go beyond the current standard of care for anxiety, depression and other central nervous system (CNS) disorders, today announced the initiation of its PALISADE Phase 3 clinical program with the PALISADE-1 Phase 3 trial, a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of PH94B for the acute treatment of anxiety in adults with Social Anxiety Disorder (SAD). PH94B is an odorless, rapid-onset, investigational pherine nasal spray with a unique mechanism of action, working differently than all existing therapies for SAD. There is currently no U.S. Food and Drug Administration (FDA) approved acute treatment of anxiety for adults with SAD.

PALISADE-1 is being conducted across approximately 18 sites in the U.S., with a target of approximately 200 randomized subjects. Dr. Michael Liebowitz, a Columbia University psychiatrist, former director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute, director of the Medical Research Network in New York City, and creator of the Liebowitz Social Anxiety Scale (LSAS), is serving as Principal Investigator of the trial. Topline results from PALISADE-1 are anticipated in mid-2022.

"Initiation of PALISADE-1 is a major milestone for our PALISADE Phase 3 clinical program for PH94B, a program aimed at supporting a potential New Drug Application to the FDA. The trial is an essential next step in our efforts to confirm the positive efficacy and safety results we have seen in all PH94B Phase 2 trials to date," stated Shawn Singh, Chief Executive Officer of VistaGen. "PH94B has the potential to be a life-changing acute, as-needed treatment of anxiety for adults with SAD, similar to how a rescue inhaler is used to prevent an asthma attack. At a time of continuing increase in the number of Americans suffering from SAD and other anxiety disorders, and a current treatment paradigm that falls short of delivering necessary relief, a new fast-acting treatment alternative is imperative. Initiation of our PALISADE-1 trial further reflects our commitment to go beyond the current standard of care for SAD. If successfully developed, PH94B has the potential to be the first fast-acting, non-systemic, non-sedating acute treatment of anxiety for more than 23 million Americans who suffer from SAD."

"Social Anxiety Disorder is the third most common mental health disorder among Americans, and it can turn everyday social interactions into debilitating, fearful experiences for people who continue to suffer from this growing mental health condition," said Dr. Liebowitz. "Existing treatments, such as approved antidepressants, have not been effective acute treatment solutions for this large patient population. In addition, the negative side effects and safety concerns associated with benzodiazepines prescribed off-label are a significant cause for concern, as demonstrated by the FDA's Drug Safety Communication detailing the risks of benzodiazepines issued last Fall. The start of this Phase 3 trial is a major step forward in the clinical development of PH94B, an investigational drug with the potential to displace antidepressants and benzodiazepines in the treatment paradigm for SAD, as well as several other anxiety disorders."