VistaGen Therapeutics will shift course in its Phase III program for social anxiety disorder, announcing plans to use a different primary endpoint for two new Phase III trials of the nasal spray fasedienol.

After the Phase III PALISADE-1 trial (NCT04754802) missed its primary endpoint last July, VistaGen has now elected to stop the ongoing PALISADE-2 trial (NCT05011396) and refocus efforts on a new Phase III program. The planned FEARLESS-1 trial will use the primary endpoint of the Liebowitz Social Anxiety Scale (LSAS), which assesses the role that social anxiety and avoidance play in 24 day-to-day scenarios.

Both PALISADE-1 and PALISADE-2 used the primary endpoint of Subjective Units of Distress Scale (SUDS), a 100-point measure of social performance and anxiety. In each study, patients administered fasedienol or placebo 20 minutes before an induced public speaking challenge, measuring SUDS during the public speaking exercise.

The FDA gave VistaGen the green light to use LSAS for all future Phase III trials of fasedienol in LSAS.

VistaGen plans to conduct a subsequent Phase III trial and open-label extension according to FDA guidance as part of a potentially NDA-enabling Phase III FEARLESS program. The biotech also intends to discuss dosing strategies for fasedienol with the FDA in subsequent meetings, including the possibility of additional dosing studies in parallel with FEARLESS-1.

VistaGen has halted the PALLISADE-2 trial and plans to report topline data from the 140 patients that completed the study in the second half of 2023. The biotech said an interim analysis did not indicate futility, but VistaGen felt the FEARLESS program was a better use of company resources. The PALISADE-2 trial had a planned enrollment of 208 patients, according to its listing.

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New approach to social anxiety disorder

Fasedienol, also known as PH94B, is a fast-acting nasal spray that regulates the olfactory-amygdala neural circuits of fear and anxiety.

Social anxiety disorder affects an estimated 25 million people in the US, impeding daily activities such as speaking in public, meeting new people, and dating. The current standard of care is antidepressants or benzodiazepines, both of which have demonstrated efficacy but notable tolerability concerns.

In a previous Phase IIa trial (NCT04404192) of fasedienol in adjustment disorder with anxiety, there were no reported severe or serious adverse events, and the most commonly reported event was a headache in 15.8% of patients.