22 June 2022 - - The last patient has completed the study protocol in US-based clinical-stage central nervous system -focused biopharmaceutical company VistaGen Therapeutics, Inc's (NASDAQ: VTGN), PALISADE-1 Phase 3 clinical trial of PH94B for the acute treatment of anxiety in adults with social anxiety disorder, the company said.

VistaGen's PALISADE-1 Phase 3 clinical trial is a US multi-center, randomized, double-blind, placebo-controlled, parallel design, clinical study in adults diagnosed with SAD.

The study is designed to evaluate the efficacy, safety, and tolerability of the acute administration of PH94B to relieve symptoms of anxiety in adult patients living with SAD during a simulated public speaking challenge conducted in a clinical setting, measured using the Subjective Units of Distress Scale.

Topline results from VistaGen's PALISADE-1 Phase 3 clinical study are anticipated in mid-2022, consistent with the company's prior guidance.

VistaGen is also evaluating PH94B for SAD in a second Phase 3 clinical trial, PALISADE-2, a US multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial designed as a replicate of PALISADE-1 to evaluate the efficacy, safety, and tolerability of PH94B for the acute treatment of anxiety in adults with SAD. Topline results from PALISADE-2 are anticipated in late-2022.

VistaGen's PALISADE Phase 3 Program in social anxiety disorder is designed to further demonstrate the potential of PH94B as a fast-acting, acute treatment of anxiety in adults with SAD.

The company's PALISADE-1 and PALISADE-2 Phase 3 clinical trials are replicate US multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trials designed to evaluate the efficacy, safety, and tolerability of PH94B for the acute treatment of anxiety in adults with SAD.

If the company's PALISADE Phase 3 Program is successful, then VistaGen plans to submit a New Drug Application to the US Food and Drug Administration to approve the use of PH94B for the acute treatment of anxiety in adults with SAD.

The FDA has granted Fast Track designation for the development of PH94B for SAD.

Social anxiety disorder affects an estimated 25 m Americans. A person with SAD feels intense, persistent symptoms of anxiety or fear in certain social situations, such as meeting new people, making comments in a business meeting, dating, being on a job interview, answering a question in class, or talking to a cashier in a store.

Doing common, everyday things in front of people causes profound anxiety or fear of being embarrassed, evaluated, humiliated, judged, or rejected.

SAD can get in the way of going to work, attending school, or doing a wide variety of things in a situation that is likely to involve interpersonal interaction. It can lead to avoidance and opportunity costs that can significantly impact a person's employment and social activities and be very disruptive to their overall quality of life.

SAD is commonly treated long-term with certain FDA-approved antidepressants, which have a slow onset of effect (several weeks) and provide limited therapeutic benefits, and benzodiazepines, which are not FDA-approved for the treatment of SAD.

Both antidepressants and benzodiazepines have known side effects and significant safety concerns that may make them unattractive to individuals affected by SAD.

VistaGen's PH94B is a first-in-class, odorless, tasteless, rapid-onset (approximately 15 minutes) investigational pherine nasal spray with a novel mechanism of action that regulates the olfactory-amygdala neural circuits of fear and anxiety and attenuates the tone of the sympathetic autonomic nervous system.

Based on positive Phase 2 data in social anxiety disorder patients, VistaGen is currently evaluating PH94B in two Phase 3 clinical studies in the US, PALISADE-1 and PALISADE-2, for the acute treatment of anxiety in adults with SAD.

Designed for intranasal administration in low microgram doses, the proposed novel MOA of PH94B is fundamentally differentiated from all currently approved anti-anxiety medications, including benzodiazepines.

VistaGen's proposed MOA for PH94B does not involve either direct activation of GABA-A receptors or binding to neuronal receptors in the central nervous system.

Rather, PH94B's proposed MOA involves binding to receptors in peripheral chemosensory neurons in the nasal passages to regulate the olfactory-amygdala fear and anxiety neural circuits.

Both clinical and preclinical data suggest that PH94B has the potential to achieve rapid-onset anti-anxiety effects without systemic uptake or transport into the brain, reducing the risk of benzodiazepine-like side effects and other safety concerns.

VistaGen is conducting a Phase 2A clinical trial to evaluate the potential use of PH94B to treat adjustment disorder with anxiety and is considering the evaluation of PH94B for potential use in the treatment of other anxiety-related disorders, including procedural anxiety, post-traumatic stress disorder, postpartum anxiety, and panic disorder.

VistaGen (NASDAQ: VTGN) is a late clinical-stage, central nervous system -focused biopharmaceutical company striving to transform the treatment landscape for individuals living with anxiety, depression and other CNS disorders.