Vistagen (Nasdaq: VTGN), a late clinical-stage company dedicated
to pioneering neuroscience based on nose-to-brain neurocircuitry,
today announced that it will present posters highlighting new
prevalence data for social anxiety disorder (SAD), an indication
for which fasedienol, its lead intranasal pherine product
candidate, is in U.S. registration-directed Phase 3 development for
the acute treatment of the disorder, and two additional
non-systemic intranasal pherine product candidates in its
neuroscience pipeline, itruvone in Phase 2 development for major
depressive disorder and hormone-free PH80 in Phase 2 development
for the management of vasomotor symptoms (hot flashes) due to
menopause, at the 2024 Neuroscience Education Institute (NEI)
Congress in Colorado Springs, Colorado from November 7 to 10,
2024.
Poster Presentation Date: Friday, November 8, 2024, 3:35
p.m. Mountain Time Title: Prevalence Trends and Demographic
Profiles of Social Anxiety Disorder: A Cross-sectional Study Using
U.S. National Health and Wellness Survey Authors: Ross A. Baker,
PhD; Josh Prince; Soohyun Hwang, PhD, MPH; Nikoletta Sternbach
Poster Number: 95
Poster Presentation Date: Friday, November 8, 2024, 3:35
p.m. Mountain Time Title: Itruvone Nasal Spray Depolarizes
Electrogram of Nasal Receptors and Increases Gamma Bandwidth of the
Olfactory Bulb Electrogram in Healthy Subjects Authors: Louis
Monti, MD, PhD; Danajane Katz, BS; Ester Salmán, MPH; Weiping
Zhang, PhD; Ross A. Baker, PhD; Rita Hanover, PhD Poster Number:
66
Poster Presentation Date: Friday, November 8, 2024, 3:35
p.m. Mountain Time Title: Pain Symptom Cluster Analysis from the
Daily Symptom Report in a Phase 2a Study of PH80 for the Treatment
of Premenstrual Dysphoric Disorder (PMDD) Authors: Louis Monti, MD,
PhD; Ross A. Baker, PhD; Rita Hanover, PhD Poster Number: 94
The posters will be available on the Publications page of
Vistagen’s website on Monday, November 11, 2024.
About Fasedienol Nasal Spray for Acute Treatment of Social
Anxiety Disorder Fasedienol is a potential first-in-class,
investigational neuroactive pherine nasal spray designed to have
rapid onset with a novel mechanism of action (MOA) that is
differentiated from all currently approved anxiety medications.
Fasedienol is designed to regulate the olfactory-amygdala neural
circuits of fear and anxiety and attenuate the tone of the
sympathetic autonomic nervous system, without systemic absorption,
potentiation of GABA-A receptors, or direct activity on neurons in
the brain. Vistagen’s U.S. registration-directed PALISADE Phase 3
program for fasedienol is focused on the acute treatment of SAD.
Fasedienol has not demonstrated any signals of abuse potential or
suggested any potential for psychological and physical dependence
in any clinical trial conducted to date. There is no U.S.
FDA-approved acute treatment for SAD. The U.S. FDA has granted Fast
Track designation for the investigation of fasedienol for the acute
treatment of SAD.
About Itruvone Nasal Spray for Major Depressive Disorder
Itruvone is an investigational pherine nasal spray designed to have
rapid onset, with a novel proposed neurocircuitry-focused mechanism
of action (MOA) that is fundamentally differentiated from the MOA
of all currently approved treatments for depression disorders.
Itruvone is administered intranasally at microgram-level doses and
is designed to regulate olfactory-to-amygdala neural circuitry
believed to increase the activity of the limbic-hypothalamic
sympathetic nervous system and increase the release of
catecholamines to produce antidepressant effects, without systemic
absorption or brain penetration and without many of the side
effects and safety concerns potentially associated with currently
approved antidepressants. The FDA has granted Fast Track
designation for the development of itruvone as a potential
treatment for major depressive disorder.
About PH80 Nasal Spray for Vasomotor Symptoms (Hot Flashes)
Due to Menopause PH80 is a hormone-free investigational
neuroactive pherine nasal spray with a novel neurocircuitry-focused
mechanism of action (MOA) that is fundamentally differentiated from
all currently approved treatment options for women’s health
indications. PH80’s proposed MOA does not require systemic
absorption or direct activity on neurons in the brain. Vistagen is
developing PH80 as a potential new non-systemic, hormone-free
treatment for the management of vasomotor symptoms (hot flashes)
due to menopause.
About Vistagen Headquartered in South San Francisco, CA,
Vistagen (Nasdaq: VTGN) is a late clinical-stage company leveraging
a deep understanding of nose-to-brain neurocircuitry to develop and
commercialize a broad and diverse pipeline of intranasal product
candidates called pherines. Each pherine product candidate in
Vistagen’s neuroscience pipeline is designed to rapidly activate
olfactory system and brain neurocircuitry to achieve desired
therapeutic benefits and differentiated safety without requiring
systemic absorption or direct activity on neurons in the brain.
Vistagen’s neuroscience pipeline also includes an oral prodrug,
AV-101, with potential to impact certain neurological conditions
involving the NMDA receptor. Vistagen is passionate about
developing transformative treatment options to improve the lives of
individuals underserved by the current standard of care for
multiple highly prevalent disorders, including social anxiety
disorder, major depressive disorder, and vasomotor symptoms (hot
flashes) associated with menopause. 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
fasedienol, itruvone, PH80, or any of the Company’s other product
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 Annual Report on Form 10-K
for the fiscal year ended March 31, 2024, and in the Company’s
Quarterly Report on Form 10-Q for the period ended June 30, 2024,
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/20241105059763/en/
Investors: Mark McPartland Vistagen Therapeutics
markmcp@vistagen.com
Media: Caren Scannell Vistagen Therapeutics
cscannell@vistagen.com
Vistagen Therapeutics (NASDAQ:VTGN)
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