Despite failing a previous late-stage study, VistaGen’s fasedienol finally scored a win by meeting its primary endpoint and strongly easing distress among patients with social anxiety disorder.
Pictured: Man feeling anxious while in a group/iStock, Prostock-Studio
VistaGen Therapeutics on Monday posted positive topline data from the Phase III PALISADE-2 trial, showing that its investigational nasal spray fasedienol met its primary endpoint, strongly easing distress among patients with social anxiety disorder.
The market reacted enthusiastically to the news, sending VistaGen’s stock soaring around 900% in Monday afternoon trading. At one point during the day, the company was trading more than 1,000% higher than its closing price Friday.
Data from PALISADE-2 “highlight the potential for fasedienol, with its novel and unique proposed mechanism of action, to transform what is possible for more than 25 million people living with social anxiety in the U.S.,” VistaGen CEO Shawn Singh said in a statement.
Compared with placebo, fasedienol led to a significantly greater reduction in the participants’ score in the Subjective Units of Distress Scale (SUDS), a validated tool used to measure the intensity of distress, anxiety, anger and other similar negative emotions. Treatment with VistaGen’s nasal spray also led to a higher proportion of clinical-assessed responders versus placebo.
In terms of safety, PALISADE-2 found fasedienol to be well-tolerated inducing no severe or serious side effects. All treatment-emergent adverse events were mild or moderate in severity, and none of which exceeded a 2% occurrence rate in the fasedienol group.
According to VistaGen’s announcement, PALISADE-2 is the first “positive U.S. Phase 3 study of an investigational therapy for social anxiety disorder in over 15 years.”
Designed to be available intranasally, fasedienol is a rapid-onset pherine nasal spray with first-in-class potential. The drug works by regulating the olfactory-amygdala circuits for fear and anxiety and blunting the sympathetic autonomic nervous system. Unlike most anti-anxiety medications, fasedienol can be given in low-microgram doses and avoids systemic distribution, potentiation of GABA-A receptors or exerting any direct activity on brain neurons.
Despite fasedienol’s victory on Monday, the candidate had previously failed the Phase III PALISADE-1 study, unable to elicit a significant improvement in SUDS score versus placebo. Following this failure, VistaGen paused enrollment into PALISADE-2 and contracted independent biostatisticians to conduct an interim review of unblinded data.
In September 2022, the external analysis said that the company could proceed with the study. However, in February 2023, VistaGen opted to hold off on resuming PALISADE-2.
VistaGen’s decision to keep PALISADE-2 on hold was spurred by “two recently completed public speaking challenge [social anxiety disorder] studies conducted by peers, each of which did not achieve its primary efficacy endpoint,” the company noted in its fiscal third-quarter 2023 financial report. VistaGen was referring to Vanda Pharmaceuticals and Bionomics, both of which failed Phase II studies in December 2022.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
