Vistagen Reports Positive Safety and Efficacy Results for Fasedienol in Social Anxiety Disorder Study

Vistagen announced positive topline results from an exploratory Phase 2 study of its intranasal drug fasedienol in 61 adults with social anxiety disorder. The trial met its safety objectives, showing that a repeat dose administered ten minutes after the first was as safe and well-tolerated as a single dose. While overall efficacy differences did not reach statistical significance, a prespecified analysis of patients with very severe social anxiety showed nominally statistically significant improvements.

Repeat dose Phase 2 results

• ▪Vistagen announced topline results from an exploratory Phase 2 clinical study evaluating fasedienol nasal spray in 61 adult subjects with social anxiety disorder.
• ▪The Phase 2 study evaluated two 3.2 µg doses of fasedienol administered ten minutes apart compared with a single 3.2 µg dose and placebo for acute anxiety during a public speaking challenge.
• ▪Both active treatment arms in the Phase 2 study showed numerical separation from placebo in subjective units of distress score changes, though the differences were not statistically significant.

Very severe subgroup efficacy

• ▪In a prespecified analysis of patients with very severe social anxiety disorder, fasedienol showed nominally statistically significant responses for the single-dose arm and pooled fasedienol compared to placebo.
• ▪The nominally statistically significant improvement in the very severe social anxiety disorder subpopulation is consistent with post-hoc analysis results from Vistagen's PALISADE-4 Phase 3 trial.

Safety tolerability profile

• ▪The exploratory Phase 2 study met its safety objective, demonstrating that a second dose of fasedienol administered ten minutes after the first produced safety and tolerability data comparable to a single dose.
• ▪The Phase 2 study of fasedienol revealed no new safety findings, with overall safety findings remaining consistent with previous clinical studies.

FDA registrational pathway discussions

• ▪Vistagen plans to use the Phase 2 efficacy signals and responder analyses to inform upcoming discussions with the FDA regarding a potential registrational pathway for fasedienol.
• ▪Because the Phase 2 study was not powered to demonstrate statistical significance, there is no assurance the FDA will view the findings as supportive of a registrational pathway.

Social anxiety disorder prevalence

• ▪Social anxiety disorder can disrupt social life, hinder occupational functioning, and increase the risk of depression, substance use disorders, and suicidal ideation.
• ▪Social anxiety disorder is a highly prevalent psychiatric mental health disorder that affects over 30 million adults in the United States.

Fasedienol mechanism of action

• ▪Unlike benzodiazepines, fasedienol has no observed potentiation of GABA-A receptors and has no observed binding on dopamine or opiate receptors isolated from the brain.
• ▪Fasedienol is an intranasal pherine designed to modulate the nasal-limbic amygdala fear and anxiety neurocircuits without requiring systemic absorption or uptake into the brain.

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