Vistagen to Present at the 2024 American Society of Clinical Psychopharmacology (ASCP) Conference
23 Maggio 2024 - 2:30PM
Business Wire
Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical
company pioneering neuroscience to deliver groundbreaking therapies
for individuals affected by psychiatric and neurological disorders,
today announced that it will present posters highlighting
fasedienol, its investigational pherine candidate in Phase 3
development for the acute treatment of social anxiety disorder
(SAD), and itruvone, its investigational pherine candidate in Phase
2 development for the treatment of major depressive disorder (MDD),
at the American Society of Clinical Psychopharmacology Conference
in Miami Beach, Florida from May 28 to 31, 2024.
Poster Presentation
Date: Wednesday, May 29, 2024, 11:15 a.m. Eastern Time Title:
Fasedienol (PH94B) Nasal Spray for Acute Treatment of Social
Anxiety Disorder (SAD): Results from the PALISADE-2 Phase 3 Trial
Authors: Michael R. Liebowitz, MD; Ester Salmán, MPH; Rita Hanover,
PhD; Brittany Reed, PA; Ross A. Baker, PhD; and Louis Monti, MD,
PhD Poster Number: W96
Poster Presentation
Date: Wednesday, May 29, 2024, 11:15 a.m. Eastern Time Title:
Brain and Peripheral Tissue Distribution of Intranasal Radiolabeled
Itruvone (PH10) in Laboratory Rats Authors: Jo Cato PhD; Ross A.
Baker, PhD; and Louis Monti, MD, PhD Poster Number: W78
The posters will be available on the Publications page of
Vistagen’s website on Monday, June 3, 2024.
About Fasedienol Nasal Spray
Vistagen’s fasedienol (PH94B) is a first-in-class, synthetic
rapid-onset investigational pherine nasal spray in Phase 3
development for the acute treatment of social anxiety disorder
(SAD). Fasedienol’s novel neurocircuitry-focused proposed mechanism
of action (MOA) is differentiated from the SSRIs and SNRI currently
approved for the treatment of SAD, as well as all benzodiazepines
and other medications prescribed off label for SAD. There is no
FDA-approved acute treatment of SAD. When administered intranasally
in microgram-level doses, fasedienol activates receptors in
peripheral nasal chemosensory neurons that, in turn, activate
olfactory system neurocircuitry and limbic amygdala neurocircuits
involved in the pathophysiology of SAD, and potentially other acute
anxiety and mood disorders. Fasedienol is pharmacologically active
without requiring systemic absorption and distribution, or binding
to neurons in the brain. Given fasedienol’s rapid-onset MOA and
patient-tailored as-needed administration, it has the potential to
become the first FDA-approved acute treatment for SAD, which is the
focus of Vistagen’s ongoing registration-directed PALISADE Phase 3
program. The U.S. FDA has granted Fast Track designation for the
investigation of fasedienol nasal spray for the acute treatment of
SAD.
About Itruvone Nasal Spray
Itruvone (PH10) is a synthetic rapid-onset investigational
pherine nasal spray in Phase 2 development for the treatment of
moderate to severe major depressive disorder (MDD). Itruvone’s
proposed mechanism of action (MOA) is fundamentally differentiated
from the MOA of all currently approved treatments for MDD.
Administered intranasally at microgram-level doses, itruvone’s MOA
involves the regulation of olfactory-to-amygdala neural circuits
believed to increase the activity of the limbic-hypothalamic
sympathetic nervous system and increase the release of
catecholamines. Unlike all currently approved depression therapies,
itruvone does not require systemic absorption and distribution or
binding to neurons in the brain to produce antidepressant effects
without the side effects and safety concerns that may be associated
with current antidepressant therapies. The U.S. FDA has granted
Fast Track designation for the development of itruvone as a
potential treatment for MDD.
About Vistagen
Vistagen (Nasdaq: VTGN) is a biopharmaceutical company
pioneering neuroscience to deliver groundbreaking therapies for
individuals affected by psychiatric and neurological disorders.
Five of Vistagen’s clinical-stage neuroscience pipeline candidates
belong to a new class of drugs known as pherines, which are
investigational neuroactive nasal sprays with innovative proposed
mechanisms of action that activate chemosensory neurons in the
nasal passages to impact fundamental neural circuitry in the brain
without the need for systemic absorption or binding to receptors in
the brain. Vistagen’s sixth investigational candidate is an oral
prodrug with potential to modulate NMDA receptor activity. At
Vistagen, we are passionate about delivering differentiated
treatments that set new standards of care for people living with
anxiety, depression, and other neurological 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 Vistagen (the Company) and its
management, are inherently uncertain. As with all pharmaceutical
products, there are substantial risks and uncertainties in the
process of development and commercialization and actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. Among other things, there can
be no guarantee that any of the Company’s drug candidates will
successfully complete ongoing or future clinical trials, receive
regulatory approval or be commercially successful. These risks and
others are more fully discussed in the section entitled “Risk
Factors” in the Company’s most recent Annual Report on Form 10-K
for the fiscal year ended March 31, 2023, and in the Company’s
Quarterly Report on Form 10-Q for the period ended December 31,
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). The Company’s SEC filings
are available on the SEC’s website at www.sec.gov. You should not
place undue reliance on these forward-looking statements, which
apply only as of the date of this press release and should not be
relied upon as representing the Company’s views as of any
subsequent date. The Company explicitly disclaims any obligation to
update any forward-looking statements other than as may be required
by law. If the Company does update one or more forward-looking
statements, no inference should be made that the Company will make
additional updates with respect to those or other forward-looking
statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20240523119550/en/
Investors: Mark McPartland Vistagen Therapeutics
markmcp@vistagen.com
Media: Caren Scannell Vistagen Therapeutics
cscannell@vistagen.com
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