Vistagen Presents Poster at Psych Congress 2022 Highlighting Effect of PH94B on Nasal Electrogram Responses and Biomarkers of Autonomic Nervous System Activity in Healthy Human Subjects
September 19 2022 - 8:30AM
Business Wire
In healthy subjects, intranasal administration
of PH94B activated nasal chemosensory cells, rapidly reduced
sympathetic tone, and provided rapid self-reported calmness
Vistagen (Nasdaq: VTGN), a 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 that data highlighting intranasal
administration of PH94B, the Company’s first-in-class synthetic
investigational pherine nasal spray in Phase 3 development for
acute treatment of social anxiety disorder, were presented at Psych
Congress in New Orleans on September 18, 2022.
PH94B is an investigational pherine nasal spray thought to
regulate the olfactory-amygdala circuits of fear and anxiety
without direct GABA-A receptor activation or binding to other CNS
receptors. In the presented study, Vistagen compared the effect of
intranasal administration of PH94B and steroidal hormones on the
electrical activity (the electrogram) of the nasal chemosensory
mucosa and on biomarkers of autonomic nervous system activity.
Data presented suggest that intranasal administration of PH94B
to healthy volunteers significantly increased the electrogram
response recorded from the nasal mucosa, while rapidly lowering
heart rate, respiratory rate, and electrodermal activity consistent
with decreased sympathetic nervous system activity (which is
activated in situations involving fear and stress, among others).
After receiving intranasal PH94B, subjects felt calmer and less
tense per self-report, suggesting an anxiolytic effect, while
steroid hormones or placebo had no such effect on the measured
biological or behavioral parameters. As with all clinical trials of
PH94B completed to date, no severe or serious adverse events were
reported for PH94B. These results support the Company’s
experimental program to demonstrate therapeutic biological and
behavioral changes after intranasal administration of PH94B.
"Pherines are a new class of pharmaceuticals acting on receptors
of nasal chemosensory cells that activate nasal-amygdala neural
circuits controlling fear, anxiety, and mood, with rapid-onset of
effect and without the need of systemic distribution or transport
into the brain,” stated Louis Monti, M.D., Ph.D., Vistagen’s Vice
President, Translational Medicine. “These positive data support the
activation of target nasal receptors and sympatholytic effects
following intranasal administration of PH94B, concurrent with
self-reported calmness and relaxation, further contributing to our
understanding PH94B’s proposed mechanism of action and its
potential to produce fast-acting anxiolytic effects.”
About PH94B
Vistagen’s PH94B is a first-in-class, rapid-onset (approximately
15 minutes) investigational pherine nasal spray with a novel
proposed mechanism of action (MOA) that regulates the
olfactory-amygdala neural circuits of fear and anxiety and
attenuates the tone of the sympathetic autonomic nervous system,
without systemic distribution, potentiation of GABA-A or direct
activity on CNS neurons in the brain. Vistagen is evaluating PH94B
in Phase 3 development for the acute treatment of anxiety in adults
with social anxiety disorder and in exploratory Phase 2 development
for the treatment of adjustment disorder with anxiety. Designed for
intranasal administration in low microgram doses, the proposed
novel MOA of PH94B is fundamentally differentiated from all
currently approved anti-anxiety medications, including
benzodiazepines.
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage, CNS-focused
biopharmaceutical company aiming to transform the treatment
landscape for individuals living with anxiety, depression and other
CNS disorders. The Company is advancing therapeutics with the
potential to be faster-acting, and with fewer side effects and
safety concerns, than those that are currently available. PH94B and
PH10 belong to a new class of drugs known as pherines, which are
investigational neuroactive steroid nasal sprays designed with a
novel rapid-onset mechanism of action that activates chemosensory
neurons in the nasal passages and can impact the olfactory-amygdala
neural circuits without systemic distribution or direct activity on
CNS neurons in the brain. Vistagen is passionate about transforming
mental health care and redefining what is possible in the treatment
of anxiety and depression. 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 and its management,
are inherently uncertain. As with any pharmaceutical product, 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 the Company’s PALISADE-2 Phase 3 clinical
trial will be successful or that PH94B or any of the Company’s
other drug candidates will receive regulatory approval or be
commercially successful. Other factors that may cause such a
difference include, without limitation, risks and uncertainties
relating to resuming and completing the Company’s PALISADE-2 Phase
3 clinical trial; the effect, if any, of the previously announced
topline results of the Company’s PALISADE-1 Phase 3 clinical trial;
the completion and results of the Company’s ongoing clinical
studies of PH94B, including the Company’s Phase 2A clinical trial
of PH94B in adults experiencing adjustment disorder with anxiety;
delays in launching, conducting and/or completing other ongoing and
planned clinical trials, including delays due to the impact of the
ongoing COVID-19 pandemic; fluctuating costs of materials and other
resources required to conduct the Company’s ongoing and/or planned
clinical and non-clinical trials; market conditions; the impact of
general economic, industry or political conditions in the United
States or internationally; and other technical and unexpected
hurdles in the development, manufacture and commercialization of
the Company’s CNS drug candidates. These risks are 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, 2022
and in the Company’s most recent Quarterly Report on Form 10-Q for
the quarter ended June 30, 2022, as well as discussions of
potential risks, uncertainties, and other important factors in the
Company’s 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220919005329/en/
Investors: Mark Flather Vice President, Investor
Relations (650) 577-3617 mflather@vistagen.com
Media: Nate Hitchings SKDK nhitchings@skdknick.com
VistaGen Therapeutics (NASDAQ:VTGN)
Historical Stock Chart
From Mar 2024 to Apr 2024
VistaGen Therapeutics (NASDAQ:VTGN)
Historical Stock Chart
From Apr 2023 to Apr 2024