Positive PALISADE-2 Phase 3 study of fasedienol yields statistically significant top-line results for the acute treatment of anxiety in adults with SAD
Vistagen’s PALISADE-2 Phase 3 trial (n=141) was a U.S. multi-center, randomized, double-blind, placebo-controlled study of fasedienol in adults diagnosed with SAD. The study was designed to evaluate the efficacy, safety, and tolerability of the acute (single-dose) administration of fasedienol to relieve anxiety symptoms in adult patients with SAD during a simulated anxiety-provoking public speaking challenge in a clinical setting, as measured using the patient-reported Subjective Units of Distress Scale (SUDS).
PALISADE-2 met its primary efficacy endpoint, the difference in mean SUDS score during the public speaking challenge at baseline (Visit 2) and treatment (Visit 3) for patients who received fasedienol (n=70) versus placebo (n=71) at Visit 3. Fasedienol-treated patients demonstrated a statistically significant greater change in mean SUDS score (least-squares (LS) mean = -13.8) compared to placebo (LS mean = -8.0), for a difference between groups of -5.8 (p=0.015).
The trial also met its secondary endpoint, demonstrating a statistically significant difference in the proportion of clinician-assessed responders between fasedienol and placebo as measured by the Clinical Global Impressions Improvement (CGI-I) scale. Responders were identified as those patients who were rated ‘very much less anxious’ or ‘much less anxious’ with 37.7% (n=69) of fasedienol-treated patients rated as responders, as compared to 21.4% (n=70) of those treated with placebo (p=0.033).
Additionally, the trial met the important exploratory endpoint of the difference in the proportion of patient-assessed responders between fasedienol and placebo as measured by the Patient’s Global Impression of Change (PGI-C) scale. Responders were identified as those patients who self-rated ‘very much less anxious’ or ‘much less anxious’ with 40.6% (n=69) of fasedienol-treated patients rated as responders, as compared to 18.6% (n=70) of those treated with placebo (p=0.003).
Finally, the trial also met the exploratory endpoint of the difference in the proportion of patients in each treatment group with a 20-point improvement in patient-assessed SUDS score from baseline (Visit 2) to treatment (Visit 3). Of the fasedienol-treated patients, 35.7% (n=70) demonstrated this statistically significant and clinically meaningful improvement in SUDS score, as compared to 18.6% (n=70) in the placebo-treated group (p=0.020).
Fasedienol was observed to be well-tolerated with no severe or serious adverse events (AEs) reported. All treatment-emergent AEs reported for the overall study were mild or moderate. There were no AEs reported in the fasedienol treatment arm above 2% occurrence.
Fasedienol is an investigational neuroactive pherine nasal spray with a proposed rapid-onset, non-systemic MOA that sets it apart from all currently approved anti-anxiety medications.
PALISADE-3 and PALISADE-4 Phase 3 clinical trials to be initiated in 2024
To complement the positive results from PALISADE-2, Vistagen is preparing to launch two similar Phase 3 clinical trials in 2024, PALISADE-3 in the first half of 2024 and PALISADE-4 in the second half of 2024. Like PALISADE-2, both PALISADE-3 and PALISADE-4 will be multi-center, randomized, double-blind, placebo-controlled, Phase 3 clinical trials designed to evaluate the efficacy, safety, and tolerability of the acute administration of fasedienol to relieve anxiety symptoms in adult patients with SAD after a single dose of fasedienol during a simulated, anxiety-provoking public speaking challenge in a clinical setting, as measured using the patient-reported SUDS as the primary efficacy endpoint. If successful, Vistagen believes either PALISADE-3 or PALISADE-4, together with PALISADE-2, may establish substantial evidence of the effectiveness of fasedienol in support of a potential fasedienol NDA submission for the acute treatment of anxiety in adults with SAD with the FDA.
