Vistagen is preparing for a real-world Phase III trial investigating fasedienol to treat social anxiety disorder.
After positive feedback from the US Food and Drug Administration (FDA), the company plans to initiate the trial in the second half of 2024.
The Phase III FEARLESS trial will be designed similarly to other registrational trials that led to drug approvals in social anxiety disorder and will be using the Liebowitz Social Anxiety Scale (LSAS) as a primary efficacy endpoint.
The study will be conducted in a real-world setting over a multiple-week period with patients receiving tailored administrations of fasedienol up to six times daily.
Vistagen claimed that such a trial design would align with the real-world treatment of social anxiety disorder with fasedienol if the drug gets approved. The planned treatment model includes acute anxiety reduction and overall long-term reduction of social anxiety disorder severity.
Also known as PH94B, fasedienol is a fast-acting nasal spray that regulates the olfactory-amygdala neural circuits of fear and anxiety.
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Vistagen is also adding another Phase III trial into its PALISADE programme, with an anticipated start date in H1 2024.
The objective of the US-based trial is to evaluate if acute administration of fasedienol is able to relieve anxiety symptoms in social phobia patients during a simulated anxiety-provoking public speaking challenge.
The trial will measure the efficacy, safety, and tolerability of fasedienol using the patient-reported Subjective Units of Distress Scale (SUDS) score as the primary efficacy endpoint.
The additional PALISADE and the FEARLESS trials are hoped to complement the PALISADE-2 trial, potentially leading to new drug application (NDA) for fasedienol.
Positive PALISADE-2 topline data
At the beginning of this month, Vistagen reported positive topline data from the PALISADE-2 trial. Patients treated with fasedienol demonstrated a statistically significant greater change in mean SUDS score compared to the placebo cohort, which was the primary endpoint.
The trial also met its secondary endpoint with treated patients achieving a statistically significant difference in the proportion of clinician-assessed responders, which was measured by the Clinical Global Impressions Improvement (CGI-I) scale.
Additionally, the trial met two exploratory endpoints and fasedienol was well-tolerated with no severe or serious adverse events (AEs) reported.
Flop in PALISADE-1 trial
Vistagen’s social anxiety disorder programme underwent reshuffling after a failure in a PALISADE-1 trial. Last year, the company announced that its Phase III PALISADE-1 trial failed to meet its primary endpoint of SUDS in the public speaking challenge.
Even though the trial did not meet the primary endpoint, the tolerability profile of fasedienol was favourable and consistent with previous studies.