Vistagen Therapeutics, Inc. announced that it will present posters highlighting fasedienol, its investigational pherine candidate in Phase 3 development for the acute treatment of social anxiety disorder (SAD), and itruvone, its investigational Pherine candidate in Phase 2 development for the treatment of major depressive disorder (MDD), at the American Society of Clinical Psychopharmacology Conference in Miami Beach, Florida from May 28 to 31, 2024. Fasedienol (PH94B) is a first-in-class, synthetic rapid-onset investigational pherine nasal spray in Phase 3 development for the Acute Treatment of Social anxiety disorder (SAD). Fasedienol's novel neurocircuitry-focused proposed mechanism of action (MOA) is differentiated from the SSRIs and SNRI currently approved for the treatment of SAD, as well as all benzodiazepines and other medications prescribed off label for SAD.

There is no FDA-approved acute treatment of SAD. When administered intranasally in microgram-level doses, fasedienol activates receptors in peripheral nasal chemosensory neurons that, in turn, activate olfactory system neurocircuitry and limbic amygdala neurocircuits involved in the pathophysiology of SAD, and potentially other acute anxiety and mood disorders. Fasedienol is pharmacologically active without requiring systemic absorption and distribution, or binding to neurons in the brain.

Given fasedienol's rapid-onset MOA and patient-tailored as-needed administration, it has the potential to become the first FDA-approved acute treatment for SAD, which is the focus of Vistagen's ongoing registration-directed PALISADE Phase 3 program. The U.S. FDA has granted Fast Track designation for the investigation of fasedienol nasal spray for the acute treatment of SAD. Itruvone (PH10) is a synthetic rapid-onset investig investigational pherine nasal Spray in Phase 2 development for thetreatment of moderate to severe major depressive disorder (MDD).

Itruvone's proposed mechanism of action (MO A) is fundamentally differentiated from the MOA of all currently approved treatments for MDD. Administrationered intranasally at microgram-level doses, itruvone's MOA involves the regulation of olfactory-to-amyAmy neural circuits believed to increase the activity of the limbic-hypothalamic sympathetic nervous system and increase the release of catecholamines. Unlike all currently approved depression therapies, itruvone does not require systemic absorption and distribution or binding to neurons in thebrain to produce antidepressant effects without the side effects and safety concerns that may be associated with current antidepressant therapies.

The U.S.F. FDA has granted Fast Track certification for the development of itruvone as a potential treatment for MDD.