Positive top-line results from fasedienol
(PH94B) Phase 3 PALISADE-2 trial in social anxiety disorder (SAD)
to be presented by SAD expert, Dr. Michael Liebowitz, at CNS Summit
2023
Positive results from PH80 Phase 2A study in
women diagnosed with vasomotor symptoms (hot flashes) due to
menopause to be presented at the 2023 Neuroscience Education
Institute (NEI) Congress
Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical
company aiming to transform the treatment landscape for individuals
living with anxiety, depression, and other central nervous system
(CNS) disorders, today announced the Company will present at two
upcoming scientific conferences in November.
“Vistagen’s presentations highlight the significant progress we
have made to advance new therapies to address urgent unmet patient
needs,” said Shawn Singh, Chief Executive Officer of Vistagen. “We
look forward to initiating our PALISADE-3 Phase 3 clinical trial in
social anxiety disorder early next year.”
Key highlights of the oral and poster presentations include:
- Fasedienol data demonstrating statistically significant
rapid-onset reduction in patient-reported Subjective Units of
Distress Scale (SUDS) score compared to placebo in a public
speaking challenge (primary endpoint, p=0.015) in adults diagnosed
with social anxiety disorder (SAD).
- Fasedienol data demonstrating long-term, open-label treatment
from nearly 500 patients was safe and well-tolerated and provided
improved overall symptom control in adults with SAD.
- PH80 data demonstrating statistically significant reduction in
the number of hot flashes compared to placebo (p<.001) after
four weeks of treatment in women diagnosed with vasomotor symptoms
(hot flashes) due to menopause.
CNS Summit 2023
Podium Presentation Date: Friday, November 10,
2023 Time: 12:00 p.m. to 3:00 p.m. Eastern Time
Session: Neuroscience Spotlight Topic: Top-Line
Results from Phase 3 PALISADE-2 Trial of Fasedienol (PH94B) Nasal
Spray for the Acute Treatment of Social Anxiety Disorder
Presenter: Michael Liebowitz, MD
2023 Neuroscience Education Institute
(NEI) Congress
Poster Presentation Date: Friday, November 10,
2023 Title: Top-Line Results from Phase 3 PALISADE-2 Trial
of Fasedienol (PH94B) Nasal Spray in Social Anxiety Disorder
Authors: Michael R. Liebowitz, MD; Ester Salmán, MPH; Rita
Hanover, PhD; Brittany Reed, PA; Ross A. Baker, PhD; Louis Monti,
MD, PhD Presenter: Louis Monti, MD, PhD Poster
Number: 109
Poster Presentation Date: Friday, November 10,
2023 Title: A Phase 2A Clinical Study to Investigate the
Efficacy, Safety, and Tolerability of PH80 for the Acute Management
of Menopausal Vasomotor Symptoms (Hot Flashes) in Women
Authors: Louis Monti, MD, PhD; Ross A. Baker, PhD; Ester
Salman, MS; Rita Hanover, PhD Presenter: Ross A. Baker PhD
Poster Number: 47
Poster Presentation
Date: Friday, November 10, 2023 Title: A Phase 3
Open-label Safety Trial of Fasedienol (PH94B) Nasal Spray in the
Treatment of Anxiety in Adults with Social Anxiety Disorder (SAD)
Authors: Jaakko Lappalainen, MD, PhD; Ester Salmán, MPH;
Rita Hanover, PhD; Brittany Reed, PA; Ross A. Baker, PhD; Mark A.
Smith, MD, PhD; Michael R. Liebowitz, MD Presenter: Brittany
Reed, PA Poster Number: 89
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage
biopharmaceutical company aiming to transform the treatment
landscape for individuals living with anxiety, depression, and
other CNS disorders. Vistagen is advancing therapeutics with the
potential to be faster-acting, and with fewer side effects and
safety concerns, than those currently available for the treatment
of anxiety, depression, and multiple CNS disorders. Vistagen's
pipeline contains six clinical-stage product candidates, including
fasedienol (PH94B), itruvone (PH10), PH80, PH15, and PH284, each an
investigational agent belonging to a new class of drugs known as
pherines, as well as AV-101, which is an oral prodrug of an
antagonist of the N-methyl-D-aspartate receptor (NMDAR). Pherines
are neuroactive nasal sprays designed with an innovative and
differentiated proposed mechanism of action (MOA) that activates
chemosensory neurons in the nasal cavity and can beneficially
impact key neural circuits in the brain without systemic absorption
or direct activity on neurons in the brain. Vistagen is passionate
about transforming mental health care and redefining what is
possible in the treatment of anxiety, depression, and several other
CNS disorders. Connect at www.Vistagen.com.
Forward-looking Statements
This press release contains certain forward-looking statements
within the meaning of the federal securities laws. These
forward-looking statements involve known and unknown risks that are
difficult to predict and include all matters that are not
historical facts. In some cases, you can identify forward-looking
statements by the use of words such as “may,” “could,” “expect,”
“project,” “outlook,” “strategy,” “intend,” “plan,” “seek,”
“anticipate,” “believe,” “estimate,” “predict,” “potential,”
“strive,” “goal,” “continue,” “likely,” “will,” “would” and
variations of these terms and similar expressions, or the negative
of these terms or similar expressions. Such forward-looking
statements are necessarily based upon estimates and assumptions
that, while considered reasonable by the Company and its
management, are inherently uncertain. These risks and uncertainties
are fully discussed in the section entitled "Risk Factors" in our
most recent Annual Report on Form 10-K for the year ended March 31,
2023, and in our most recent Quarterly Report on Form 10-Q for the
quarter ended June 30, 2023, as well as discussions of potential
risks, uncertainties, and other important factors in our other
filings with the U.S. Securities and Exchange Commission (SEC). Our
SEC filings are available on the SEC’s website at www.sec.gov. In
addition, any forward-looking statements represent our views only
as of the issuance of this release and should not be relied upon as
representing our views as of any subsequent date. We explicitly
disclaim any obligation to update any forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20231107516146/en/
Investors: Mark McPartland Senior Vice President, Investor
Relations (650) 577-3606 markmcp@vistagen.com
Media: Nate Hitchings SKDK nhitchings@skdknick.com
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