공시 • May 13
Vistagen Announces Preliminary Positive Data in Ongoing Open-Label Extension Portion of PALISADE-3 Phase 3 Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder
Vistagen, a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, announced preliminary positive data from the ongoing open-label extension (OLE) portion of its PALISADE-3 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-3 (safety population: n=341), administration of 3.2 µg of fasedienol – taken as needed, up to six times per day in real-world, anxiety-provoking situations in daily life for up to 12 months – has been well-tolerated, with no new drug-related safety findings or trends identified. Exploratory efficacy data over the first four months of treatment demonstrated a clinically relevant improvement over time on both the clinician-administered Liebowitz Social Anxiety Scale (LSAS) and the Social Phobia Inventory (SPIN). In the OLE portion of PALISADE-3, as of May 8, 2026, fasedienol nasal spray, taken as-needed, up to six times a day, was observed to be well-tolerated in adults with social anxiety disorder. The rate of discontinuation due to adverse events was 2.6% (9/341), with no discontinuations attributed to fasedienol. Substantially all (>95%) of TEAEs were mild or moderate in severity. The only TEAEs occurring in > 5% of subjects were headache (10.9%, 37/341) and upper respiratory infection (11.4%, 39/341). There were no Serious Adverse Events related to fasedienol. No safety signals of concern were identified related to laboratory values, ECGs, physical examinations, and vital sign assessments following exposure to fasedienol. The OLE portion of PALISADE-3 explored the change from baseline (study entry) on the LSAS, a 24-item clinician-administered scale (range 0-144), which measures fear and avoidance experienced over time due to social anxiety disorder during anxiety-provoking social and performance situations. The recent analysis of a data cut from the initial four-month period in the OLE portion of PALISADE-3 demonstrated a clinically relevant improvement over time on the LSAS for subjects participating in the OLE: At study entry, the mean baseline LSAS score (99.2, n=341) indicated very severe social anxiety (=80). At Month 1, mean improvement on the LSAS was 16.3 points (n=305, 38% had a = 20 point-improvement). At Month 2, mean improvement on the LSAS was 22.4 points (n=269, 49% had a = 20 point-improvement). At Month 3, mean improvement on the LSAS was 24.1 points (n=248, 54% had a = 20 point-improvement). At Month 4, mean improvement on the LSAS was 25.4 points (n=228, 56% had = 20 point-improvement). Improvements were observed on both the fear and avoidance subscales, suggesting that patients engaging in daily life have experienced less fear and avoidance of anxiety-provoking situations. Moreover, subjects who did not respond to fasedienol administered in the simulated single-dose, clinic-based public speaking challenge during the randomized portion of PALISADE-3 showed comparable change at Month 1 and Month 4 compared to the total population in both LSAS mean improvement (Month 1 = 13.4 and Month 4 = 20.8) and LSAS response of =20 point improvement (Month 1 = 40% and Month 4 = 50% of subjects). The OLE portion of PALISADE-3 also explores the change from baseline on the SPIN, a 17-item patient-reported scale (range 0-64) which measures fear, avoidance, and physiological components of social phobia over time. The recent analysis of the initial four-month data cut from the OLE portion of PALISADE-3 demonstrated a clinically relevant improvement over time on the SPIN for subjects participating in the OLE: At study entry, the mean baseline SPIN score (48.7, n=341) indicated severe social anxiety (=41). At Month 1, mean improvement on the SPIN was 7.9 points (n=305, 35% had a = 10-point improvement). At Month 4, mean improvement on the SPIN was 12.4 points (n=228, 55% had a = 10-point improvement). The Company believes that the interim safety and exploratory efficacy results of the OLE are consistent with the safety and efficacy previously reported in the fasedienol Long Term Safety Study (LTSS) data and results of a randomized, double-blind, placebo-controlled Phase 2 crossover study of fasedienol in a real-world setting conducted by Dr. Liebowitz. Results from both prior studies suggest that as-needed self-administration of fasedienol prior to anxiety-provoking real-world situations in daily life was accompanied by a persistent change in the overall severity of social anxiety disorder. Specifically, both studies showed a reduction in fear and anxiety, and less frequent avoidance, as measured by the LSAS over the course of fasedienol usage. The OLE is a voluntary extension of the randomized double-blind, placebo-controlled portion of the PALISADE-3 Phase 3 study of fasedienol for the acute treatment of social anxiety disorder, available to participants who choose to continue in the study per the study protocol. It is designed to evaluate the safety and tolerability of multiple, as-needed intranasal administrations of fasedienol (up to six times daily, maximum daily dose of 19.2 µg fasedienol) in adults with social anxiety disorder over time in daily life. Monthly safety and tolerability assessments include monthly change in adverse events (AEs), laboratory values, 12-lead electrocardiograms (ECGs), physical examinations, and vital sign assessments. The study is also evaluating the change from baseline over time in standard clinical measurements (the LSAS and the SPIN) as participants use fasedienol in real-world social situations in their daily lives. Endpoints of the OLE portion of PALISADE-3 include a monthly evaluation of the change from baseline at study entry on the LSAS and a Month 1 and Month 4 evaluation of change from baseline at study entry on the SPIN patient self-report questionnaire. Both scales provide a validated psychological assessment of the severity of social anxiety disorder, with a focus on fear, avoidance, and physiological discomfort in social and performance situations.
