VistaGen Therapeutics, Inc. (Nasdaq: VTGN) (VistaGen), a late
clinical-stage, central nervous system (CNS)-focused
biopharmaceutical company aiming to transform the treatment
landscape for individuals living with anxiety, depression and other
CNS disorders, today announced that the clinical trial abstract for
its exploratory Phase 2A clinical study in adjustment disorder with
anxiety (AjDA) for PH94B, its investigational rapid-onset pherine
nasal spray with potential to treat multiple anxiety disorders, was
accepted by the American Society for Clinical Psychopharmacology
(ASCP) for the 2022 ASCP Annual Meeting taking place May 31 through
June 3, 2022.
The clinical trial abstract for the Company’s ongoing
exploratory Phase 2A clinical trial, entitled “Efficacy, safety,
and tolerability of PH94B in adjustment disorder with anxiety:
design of an exploratory phase 2A clinical trial,” describes
the clinical trial protocol intended to evaluate PH94B’s potential
to treat adults living with AjDA, a disorder with potential for
increased prevalence during these uncertain times. PH94B is a
first-in-class, odorless, tasteless rapid-onset (approximately 15
minutes) investigational pherine nasal spray with a novel 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. VistaGen is also currently
evaluating PH94B in the Company’s two PALISADE Phase 3 clinical
trials for the acute treatment of anxiety in adults with social
anxiety disorder (SAD).
“Mental health challenges are accelerating in communities across
America. Patients and healthcare providers are seeking better
solutions to the growing prevalence of anxiety and depression, and
VistaGen is working hard to develop innovative solutions,” said
Shawn Singh, Chief Executive Officer of VistaGen. “There is
significant demand and need for treatments for anxiety disorders,
including adjustment disorder. At this important moment and amid
this significant unmet need, we look forward to sharing our
clinical trial abstract with top psychopharmacology leaders in
attendance at the ASCP Annual Meeting."
The ASCP Annual Meeting is the premiere meeting each year in the
field of psychopharmacology and brings together over 800 academic
and industry investigators, research pharmacists, and clinicians,
the National Institutes of Health (NIH), Food and Drug
Administration (FDA), and European regulatory agencies to discuss
key aspects of neuropsychiatric drug development. In recent years,
the ASCP Annual Meeting focus has been expanded to address a number
of timely issues relevant to clinical research in psychiatry,
including the translation of research into practice, the importance
of regulatory issues, and pharmacogenetics and other means to
personalizing interventions.
About PH94B VistaGen’s PH94B is a first-in-class,
odorless, tasteless rapid-onset (approximately 15 minutes)
investigational pherine nasal spray with a novel 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. Based on positive Phase 2 data in social
anxiety disorder (SAD) patients, VistaGen is currently evaluating
PH94B in two Phase 3 clinical studies in the U.S., PALISADE-1 and
PALISADE-2, and a long-term safety study, for the acute treatment
of anxiety in adults with SAD. Designed for intranasal
administration in low microgram doses, the novel MOA of PH94B is
fundamentally differentiated from all current anti-anxiety
medications, including benzodiazepines. VistaGen’s proposed MOA for
PH94B does not involve either direct activation of GABA-A receptors
or binding to neuronal receptors in the CNS. Rather, PH94B’s
proposed MOA involves binding to peripheral chemosensory neurons in
the nasal passages to regulate the olfactory-amygdala fear and
anxiety neural circuits. Both clinical and preclinical data suggest
that PH94B has the potential to achieve rapid-onset anti-anxiety
effects without systemic uptake or transport into the brain,
reducing the risk of benzodiazepine-like side effects and other
safety concerns. In addition to SAD, for which the FDA has granted
Fast Track designation, PH94B may have potential in adjustment
disorder with anxiety, procedural anxiety, PTSD, postpartum anxiety
and panic disorder.
About Adjustment Disorder with Anxiety Almost everyone
experiences significant life events, changes, or stressors from
time to time, and while some individuals adjust to such changes
within a few months, others cannot and may experience adjustment
disorder. Adjustment disorder with anxiety (AjDA) is the
development of emotional or behavioral symptoms considered
excessive or disproportionate in response to a sudden change,
stressful event or circumstance, or other identifiable
anxiety-provoking stressor, such as loss of work, divorce or a
health setback, that significantly impairs a person’s social,
occupational and/or other important area(s) of functioning.
About VistaGen VistaGen (Nasdaq: VTGN) is a late
clinical-stage, CNS-focused biopharmaceutical company striving 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. VistaGen’s clinical-stage candidates are
targeting multiple forms of anxiety and depression. They belong to
a new class of drugs known as pherines, which are odorless,
neuroactive steroids that bind to distinct receptors on
chemosensory neurons in the nasal passages and can impact the
limbic amygdala without systemic uptake or direct activity on CNS
neurons in the brain. VistaGen’s lead candidate, PH94B, is a
nasally administered spray currently in multiple Phase 3 trials in
the U.S., with results anticipated in 2022. Should ongoing Phase 3
studies be successful, PH94B has the potential to be the first
FDA-approved, fast-acting, acute treatment of anxiety for adults
with social anxiety disorder. 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. The
Company’s actual results or developments may differ materially from
those projected or implied in these forward-looking statements.
Factors that may cause such a difference include, without
limitation, risks and uncertainties relating to delays in
launching, conducting and/or completing 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; adverse healthcare reforms and changes
of laws and regulations; manufacturing and marketing risks, which
may include, but are not limited to, unavailability of or delays in
delivery of raw materials for manufacture of the Company’s CNS drug
candidates due to the ongoing COVID-19 pandemic or otherwise;
inadequate and/or untimely supply of one or more of the Company’s
CNS drug candidates to meet demand; entry of competitive products;
and other technical and unexpected hurdles in the development,
manufacture and commercialization of the Company’s CNS drug
candidates; and the risks 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, 2021 and in the
Company’s most recent Quarterly Report on Form 10-Q for the quarter
ended December 31, 2021, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220602005364/en/
Investors Mark Flather Vice President, Investor
Relations, VistaGen Therapeutics Phone: (650) 577-3617 Email:
mflather@vistagen.com
Media Nate Hitchings SKDK Email:
nhitchings@skdknick.com
VistaGen Therapeutics (NASDAQ:VTGN)
Gráfico Histórico do Ativo
De Mar 2024 até Abr 2024
VistaGen Therapeutics (NASDAQ:VTGN)
Gráfico Histórico do Ativo
De Abr 2023 até Abr 2024
