Vistagen has enrolled the first patient in the PALISADE-3 Phase III clinical trial of fasedienol (PH94B) being developed for social anxiety disorder (SAD) treatment.
Fasedienol is a first-in-class, rapid-onset investigational pherine nasal spray and is intended for the acute treatment of SAD, which affects more than 25 million Americans.
Mirroring the design of PALISADE-2, PALISADE-3 is a double-blind, randomised, placebo-controlled study. It aims to assess the efficacy, safety, and tolerability of fasedienol for relieving anxiety symptoms in patients with SAD.
The primary measure of outcome is the Subjective Units of Distress Scale (SUDS), self-rated by patients.
The trial will involve approximately 236 adults aged 18 to 65 years across multiple US centres, with a 1:1 randomisation to either fasedienol or placebo.
Vistagen CEO Shawn Singh said: “Initiating PALISADE-3 is another major milestone in our plan to develop and commercialise fasedienol as the first treatment of its kind for social anxiety disorder.
“We look forward to initiating PALISADE-4 in the second half of this year and advancing our innovative pherine pipeline to deliver pioneering neuroscience to patients affected by mental health disorders and unsatisfied with current treatments.”
Participants completing PALISADE-3 will be eligible for an open-label extension. Vistagen anticipates the commencement of PALISADE-4, a replicate study, in the latter half of 2024.
The US Food and Drug Administration (FDA) previously granted fast track designation for fasedienol for the acute treatment of SAD.
In December 2023, Vistagen received a Notice of Intention to Grant patent from the European Patent Office (EPO) related to the use of AV-101 investigational oral prodrug for the treatment of neuropathic pain.
