VistaGen decimated as PH94B for social anxiety disorder misses endpoint

US clinical-stage biotech VistaGen Therapeutics (Nasdaq: VTGN) suffered a major setback on Friday on disappointing clinical results for a leading drug candidate, with its shares nose-diving almost 86% to $0.15.

VistaGen announced top-line results from its PALISADE-1 Phase III clinical trial of PH94B for the acute treatment of anxiety in adults with social anxiety disorder (SAD). PH94B did not achieve its primary endpoint, as measured by change from baseline using the Subjective Units of Distress Scale (SUDS) compared to placebo. Although the trial did not meet its primary endpoint, the tolerability profile of PH94B in PALISADE-1 was favorable and consistent with previously reported results from all other clinical trials. No severe or serious adverse events were reported for PH94B in prior clinical trials or in PALISADE-1.

“The demand for new treatment options for anxiety disorders is large and growing. 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,” said Shawn Singh, chief executive of VistaGen.