A nasal spray to treat anxiety did not meet its primary endpoint and was not significantly better than the placebo given during a phase 3 clinical trial.

Vistagen Therapeutics Inc’s drug, PH94B, was designed to treat people living with anxiety, depression and other central nervous system (CNS) disorders announced the topline results on Friday (July 22).

Tolerability profile

Previous results had shown a favorable safety and tolerability profile among study participants, but it fell short at the next hurdle.

VistaGen, a late clinical-stage biopharma company, said the results from its PALISADE-1 Phase 3 clinical trial of PH94B for the acute treatment of anxiety in adults with social anxiety disorder 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.

Nervous system disorders

Shawn Singh, chief executive officer of VistaGen said: “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 2 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.

“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 3 trial and for continued use in our ongoing Phase 2 trial in adjustment disorder with anxiety. We would like to thank the patients and investigators for their participation in the trial, and we will continue to evaluate the detailed data from PALISADE-1 as we move forward with our ongoing trials.”

PALISADE-1 was a multi-center, randomized, double-blind, placebo-controlled, parallel design, phase 3 clinical study in adults diagnosed with social anxiety disorder (SAD). The study was designed to evaluate the efficacy, safety, and tolerability of the acute administration of PH94B to relieve symptoms of anxiety in adult patients with SAD during a simulated public speaking challenge, measured using the patient-reported SUDS. Prior to the public speaking challenge, the subjects were randomized to receive a single dose of PH94B or placebo.

VistaGen has two other drug candidates in its CNS pipeline, PH10 and AV-101, with the potential to go beyond the current standard of care for anxiety, depression and other CNS disorders. Each of the company’s drug candidates has a differentiated potential mechanism of action, has been well-tolerated in all clinical studies to date, and has therapeutic potential in multiple CNS markets.

Anxiety disorder

PH94B was a first-in-class investigational pherine nasal spray in phase 3 development for the acute treatment of anxiety in adults with social anxiety disorder and in phase 2 development for adjustment disorder with anxiety.

VistaGen was also considering PH94B for clinical development in additional acute (on-demand) and continued use anxiety disorders, including procedural anxiety, panic disorder, postpartum anxiety and post-traumatic stress disorder.

PH10 is an investigational pherine nasal spray in clinical development as a stand-alone treatment for major depressive disorder and potentially multiple other depression-related disorders. AV-101 is an investigational oral prodrug of 7-chloro-kynurenic acid (7-Cl-KYNA), a potent and selective full antagonist of the glycine co-agonist site of the N-methyl-D-aspartate receptor is a glutamate receptor and ion channel found in neurons (NMDAR), in clinical development with potential to become a new oral treatment alternative for certain CNS indications involving the NMDAR.

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