LATEST NEWS
Vistagen enrolls first subject in Phase III trial of social anxiety disorder drug
IDENTIFYING THE OPPORTUNITY
INSTITUTIONAL SUPPORT IS IN PLACE AND READY TO RUN
We are in a significant blast zone and are seeing sparks
TARGETS
Key Level #1: $7.19 (+134.20%)
Key Level #2: $17.06 (+455.70%)
Key Level #3: $23.12 (+653.09%)
Key Level #4: $31.76 (+934.53%)
Key Level #5: $53.85 (+1654.07%)
Key Level #6: $63.21 (+1958.96%)
Potential Support: $1.48
vISTAGEN
(NSDQ: vtgn)
Bold opportunities to change the course of mental health care
Vistagen (Nasdaq: VTGN) is a biopharmaceutical company dedicated to pioneering neuroscience to develop and commercialize groundbreaking therapies for individuals affected by psychiatric and neurological disorders. To that end, Vistagen is innovating a pipeline of candidates with the potential to establish new standards of care, safety, and effectiveness for disorders that are disrupting the lives of tens of millions of people around the world.
What Sets vistagen apart: Pherines
A novel class of neuroactive therapies
Pherines, with their innovative Mechanism of Action (MOA), represent a groundbreaking approach to pharmaceutical intervention. Administered intranasally, they offer rapid efficacy while being odorless and tasteless, enhancing patient acceptability. By activating neural circuitry linked to various brain regions crucial for addressing a spectrum of Central Nervous System (CNS) disorders, pherines demonstrate a unique therapeutic potential.
Notably, their mode of action avoids systemic uptake and direct central nervous system absorption, mitigating concerns about neuronal effects. Furthermore, their non-binding nature to receptors associated with abuse liability, coupled with favorable safety profiles observed across completed clinical trials, underscores their promise as a safe and effective treatment option.
Fasedienol Nasal Spray for the Acute Treatment of Social Anxiety Disorder (SAD)
SAD is not medicalized shyness. It is a chronic disorder characterized by a number of symptoms:
Emotional Symptoms
• Overwhelming fear
• Surges of anxiety
• Extreme self-consciousness
• Isolation leading to depression
Physical Symptoms
• Blushing / Sweating
• Trembling
• Nausea
• Fast heartbeat / Chest discomfort
• Shortness of breath / Dizziness
In everyday social or performance situations...
SAD affects ~10% of the U.S. population, and unfortunately, it has been two decades since the standard therapies were approved by the FDA. Additionally, there are currently no FDA-approved acute treatment methods available for SAD, and the options that exist often fall short of physician expectations.
This is Where The Genius Of Vistagen (Nasdaq: VTGN) Comes In
- Registration-directed PALISADE Phase 3 program underway; positive PALISADE-2
- Reported in August 2023; PALISADE-3 initiated in March 2024
- Mechanism of action is differentiated from all FDA-approved products
- Designed for patient-tailored administration, as-needed
- No observed systemic absorption or direct activity on neurons in the brain
- Does not potentiate GABA or bind to abuse liability receptors
- Favorable tolerability profile, no evidence of abuse liability potential
- Potential to build confidence and reduce fear, anxiety, and avoidance of stressors
- FDA Fast Track Designation granted
Psychiatrists and Primary Care Physicians Indicate High Intent to Prescribe a Product with Fasedienol’s Profile and Note it Would Be Appropriate for the Majority of their SAD Patients
Fasedienol’s Novel Proposed Mechanism of Action
Differentiated from all current therapies for anxiety disorders
PALISADE-2 Phase 3 Trial for Acute Treatment of SAD - Public speaking challenge
Study Design
Randomized, double-blind, placebo-controlled, single-dose administration Phase 3 trial to evaluate
the efficacy, safety, and tolerability of fasedienol for the acute treatment of anxiety in adult subjects
with SAD induced by a public speaking challenge in a clinical setting
Screening Criteria
Participants meeting inclusion criteria for the study must have a diagnosis of Social Anxiety Disorder (SAD) with a Liebowitz Social Anxiety Scale (LSAS) score exceeding 70 and a Hamilton Depression Rating Scale (HAMD) score below 18 at screening. Normal olfactory function is required, with the option for a Quick Olfactory Test if suspicion arises. Additionally, individuals with no recent history of COVID-19 are eligible. Exclusion criteria encompass significant psychiatric illness or use of psychotropic medication, history of suicidal behavior, alcohol or substance use disorder, and notable nasal pathology.
Outcome Measures
The primary endpoint measured for the study was a change in mean Subjective Units of Distress (SUDS) scores from baseline compared to placebo, with a secondary endpoint focused on responder rates for Clinical Global Impression - Improvement (CGI-I)
PALISADE-2 Phase 3 Trial Efficacy Summary
The PALISADE-2 Phase 3 trial demonstrated strong efficacy of the treatment across all measured aspects. Patients experienced significant reductions in anxiety levels, as indicated by improvements in the Subjective Units of Distress Scale (SUDS) compared to placebo (p=0.015). Additionally, a notable proportion of patients reported feeling much or very much less anxious, as assessed by the Clinical Global Impression-Improvement (CGI-I) scale (p=0.033). These results highlight the treatment's effectiveness in reducing anxiety symptoms among individuals with Social Anxiety Disorder.
VISTAGEN
(NSDQ: VTGN)
Itruvone Nasal Spray for Major Depressive Disorder
Another of the company's groundbreaking medications, IItruvone is a rapid-onset investigational pherine nasal spray designed for potential stand-alone treatment for major depressive disorder and other neuropsychiatric indications involving depression. With 19.4 million American adults experiencing at least one major depressive episode, this medication could fill a massive hole in the pharmaceutical market.
Itruvone’s Novel Proposed Mechanism of Action
- Microgram-level intranasal dose of itruvone is administered intranasally
- Itruvone engages peripheral receptors in nasal chemosensory neurons (NCNs)
- NCNs trigger subgroups of interneurons in the olfactory bulbs (OBs)
- Neurons in the OBs then stimulate GABAergic and CRH neurons in the limbic amygdala
- The stimulation of the limbic amygdala INCREASES the activity of the sympathetic autonomic nervous system and the release of catecholamines from the midbrain
Vistagen
(NSDQ: VTGN)
why Vistagen Is set to leave their mark on the Dynamic Neuroscience market
Neuroscience Pipeline Overview
Vistagen (NSDQ: VTGN) stands at the forefront of the global neuroscience market, with a strong portfolio of innovative, clinical-stage medications. The team's experience and deep understanding of these novel drug candidates propel clinical endeavors aimed at pioneering therapies for individuals grappling with psychiatric and neurological disorders.
The Numbers: Large Unmet Mental Health Care Needs in Anxiety and Depression
Vistagen
(NSDQ: VTGN)
Vistagen's Leadership: Experienced and Committed
Maurizio Fava, M.D.
Harvard University - Chairman
Professor of Psychiatry, Harvard Medical School; Director, Division of Clinical Research, Massachusetts General Hospital (MGH) Research Institute; and Executive Vice Chair of the Department of Psychiatry
Thomas Laughren, M.D.
Division Director for the Division of Psychiatry Products, U.S. FDA (retired)
Director (retired), U.S. Food and Drug Administration (FDA) Division of Psychiatry Products, Office of New Drugs, Center for Drug Evaluation and Research (CDER)
Michael Liebowitz, M.D.
Columbia University; The Medical Research Network
Former Columbia University psychiatrist, director and founder of the Anxiety Disorders Clinic at the New York State Psychiatric Institute; current Managing Director of The Medical Research Network LLC
Sanjay Mathew, M.D.
Baylor College of Medicine
Vice Chair for Research and Professor of Psychiatry and Behavioral Sciences at Baylor College of Medicine; Staff Psychiatrist at the Michael E. DeBakey VA Medical Center
Gerard Sanacora, Ph.D., M.D.
Yale University
Professor of Psychiatry, YaleSchool of Medicine; Director, Yale Depression Research Program; Co-Director, Yale-New Haven Hospital Interventional Psychiatry Service
Mark Wallace, M.D.
University of California San Diego
Professor of Clinical Anesthesiology, Chair of the Division ofPain Medicine, Medical Director and Director at the University of California, San Diego
Sources
- Source 1: https://www.vistagen.com/
- Source 2: https://www.vistagen.com/pipeline/overview
- Source 3: https://www.vistagen.com/investors/overview
- Source 4: https://www.vistagen.com/static-files/b1bcf087-576a-4e58-bd6c-4f5cdd9ad907
- Source 5: https://www.vistagen.com/news-releases/news-release-details/vistagen-initiates-palisade-3-phase-3-study-fasedienol-acute
- Source 6: https://www.vistagen.com/news/press-releases
- Source 7: https://www.vistagen.com/investors/overview
- Source 8: https://www.vistagen.com/about/advisory-board
- Source 9: https://www.vistagen.com/about/advisory-board
- Source 10: https://www.vistagen.com/presentations
- Source 11: https://finance.yahoo.com/news/vistagen-enrols-first-subject-phase-085224393.html
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