Vistagen Therapeutics Inc（VTGN）のニュースとイベントVTGNVistagen Therapeutics Inc

Vistagen Reports Positive Preliminary Data from PALISADE-4 Study

Vistagen announced preliminary positive data from the open-label extension, OLE, portion of its PALISADE-4 Phase 3 study of fasedienol for the acute treatment of social anxiety disorder. In a recent analysis of subjects who elected to participate in the OLE portion of PALISADE-4, administration of 3.2 microgram of fasedienol, taken as needed up to six times per day in anxiety-provoking social and performance situations in everyday life for up to 12 months, was well-tolerated with no new drug-related safety findings. Exploratory efficacy data over the first four months of as-needed treatment demonstrated improvement over time on both the Liebowitz Social Anxiety Scale and the Social Phobia Inventory.

Vistagen Announces Phase 2 Results for Fasedienol Nasal Spray

Vistagen announced the topline results of its exploratory Phase 2 repeat dose study evaluating fasedienol nasal spray in adult subjects with social anxiety disorder. The three-arm, multicenter, randomized, double-blind, placebo controlled clinical study, which included an open label extension, was designed to assess the efficacy, safety, and tolerability of two 3.2 microgram doses of fasedienol administered ten minutes apart compared with a single 3.2 microgram dose and placebo, for the acute treatment of anxiety induced by a public speaking challenge. The study was not designed to demonstrate statistically significant differences between treatment groups. The exploratory study met its safety objective, demonstrating that a second dose administered within ten minutes of the first dose produced safety and tolerability data comparable to single-dose administration, with no new safety findings and overall safety findings consistent with previous clinical studies. In addition, both active treatment arms in the primary endpoint analysis, LS mean change in subjective units of distress score from Visit 2 to Visit 3, showed numerical separation from placebo, although the differences between treatment groups and placebo were not statistically significant. The primary efficacy results showed numerical separation from placebo in mean SUDS change from V2 to V3. In the prespecified analysis of patients with very severe social anxiety disorder as defined by a baseline Liebowitz Social Anxiety Scale score of greater than or equal to 95, fasedienol showed nominally statistically significant responses for the single dose arm compared with placebo and as pooled. The treatment effect for repeat dose fasedienol was numerically larger, although the smaller sample size and variability resulted in a higher p-value. The findings in the very severe group of patients defined by LSAS greater than or equal to 95 are consistent with results previously observed in the randomized portion of the company's PALISADE-4 Phase 3 trial for the acute treatment of social anxiety disorder, where in a post-hoc analysis of patients with very severe social anxiety defined by LSAS greater than or equal to 95, fasedienol also demonstrated a nominally statistically significant improvement compared with placebo. Responder rates for the Clinician Global Impression of Improvement and the Patient Global Impression of Change secondary endpoints were directionally higher for fasedienol than placebo, providing consistency across primary and secondary endpoints for the total population in the study. In addition, the fasedienol responder rates in the repeat dose arm were more than twice those observed with placebo. A prespecified exploratory analysis in V2 to V3 change of anticipatory anxiety prior to the beginning of the public speaking challenge showed a larger decrease in mean SUDS score for fasedienol compared with placebo, with the repeat dose and pooled fasedienol showing nominal statistical significance.