VistaGen’s social anxiety disorder treatment fails to meet primary endpoint in Phase III

VistaGen Therapeutics has announced topline data from its Phase III PALISADE-1 trial which shows that PH94B, its nasal spray candidate for anxiety, depression, and other CNS disorders, fell short of its primary endpoint.

PALISADE-1 was a randomised, double-blinded, parallel study which enrolled over 200 participants with a social anxiety disorder (SAD) across the US. The trial compared PH94B with a nasal spray placebo, to assess if it could induce self-reported feelings of anxiety during a public speaking challenge.

As measured by the Subjective Units of Distress Scale, PH94B’s overall impact was not significantly better than that of the placebo.

"While the results of PALISADE-1 are not consistent with prior positive results from Phase II trials of PH94B in social anxiety disorder, we remain committed to transforming the treatment landscape for those living with anxiety, depression, and other central nervous system disorders," Shawn Singh, CEO of VistaGen, said in a statement. 

"As part of this commitment, our team will continue to pursue PH94B's potential as a new treatment option for multiple anxiety disorders — including for both acute treatment for social anxiety disorder in our ongoing PALISADE-2 Phase III trial and for continued use in our ongoing Phase II trial in adjustment disorder with anxiety.”

PH94B delivers proprietary pherines, a family of neurosteroid compounds designed to rapidly elicit their effects. It acts through chemosensory receptors in the nose, activating a group of neurons in the amygdala, the brain region associated with stress and anxiety.

Lina Adams