SOUTH SAN FRANCISCO - Vistagen Therapeutics (NASDAQ: VTGN) has begun enrolling participants in a Phase 3 clinical trial for its investigational drug, fasedienol, aimed at treating social anxiety disorder (SAD), a condition affecting over 25 million Americans.
The trial, named PALISADE-3, will assess the efficacy, safety, and tolerability of the drug in adults aged 18 to 65, with plans to enroll approximately 236 patients.
The PALISADE-3 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the short-term effects of fasedienol. Participants will be subjected to a public speaking challenge in a clinical setting to induce anxiety symptoms, which will then be measured using the Subjective Units of Distress Scale (SUDS).
Those who complete the trial will have the opportunity to join an open-label extension study. Vistagen anticipates initiating a similar Phase 3 trial, PALISADE-4, in the latter half of 2024.
Fasedienol (PH94B) is a nasal spray with a novel mechanism of action, distinct from current SAD treatments such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and off-label prescribed benzodiazepines.
It is designed to target the olfactory-amygdala neural circuits related to fear and anxiety, potentially offering rapid onset without systemic distribution or GABA-A receptor potentiation. To date, fasedienol has not shown abuse potential or physical dependence in clinical trials.
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for fasedienol's investigation for the acute treatment of SAD. Currently, there are no FDA-approved acute treatments for SAD, with existing medications taking several weeks to take effect and often coming with side effects that may deter patients.
Vistagen is a biopharmaceutical company focused on developing therapies for psychiatric and neurological disorders. Their pipeline includes six clinical-stage candidates, five of which are pherines, a new class of neuroactive nasal sprays, and one oral prodrug aimed at modulating NMDA receptor activity.
This article is based on a press release statement.
InvestingPro Insights
As Vistagen Therapeutics (NASDAQ: VTGN) forges ahead with its Phase 3 clinical trial for fasedienol, investors and industry observers are closely monitoring the company's financial health and market potential. Recent data from InvestingPro reveals a mixed picture of the company's financial standing.
With a market capitalization of $142.69 million, Vistagen is navigating the biopharmaceutical space with significant revenue growth in the last twelve months as of Q3 2024, reporting a 386.35% increase. Despite this impressive growth, the company is facing challenges with an adjusted operating income of -$33.9 million, reflecting the high costs associated with drug development and clinical trials.
Two InvestingPro Tips that stand out for Vistagen are the analysts' anticipation of sales growth in the current year and their revision of earnings upwards for the upcoming period. These insights suggest that, although Vistagen is not expected to be profitable this year and is quickly burning through cash, there is optimism about the company's revenue prospects and earnings potential.
Furthermore, Vistagen's significant return over the last week, with a 23.36% price total return, indicates a positive market reaction, possibly linked to the latest developments in their clinical trials.
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