VistaGen Therapeutics Expands Clinical Development of PH94B with Initiation of Phase 2A Trial in Adjustment Disorder
October 14 2021 - 8:00AM
VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a biopharmaceutical
company committed to developing a new generation of medicines with
the potential to go beyond the current standard of care for
anxiety, depression, and other central nervous system (CNS)
disorders, today announced the initiation of a Phase 2A clinical
trial to evaluate the efficacy, safety and tolerability of PH94B as
a potential treatment of anxiety in adults with Adjustment Disorder
with Anxiety (AjDA). In parallel with advancing its ongoing
PALISADE Phase 3 clinical program for PH94B in the acute treatment
of anxiety in adults with Social Anxiety Disorder (SAD), the
Company plans to explore PH94B’s potential in additional anxiety
disorders through a series of small Phase 2A trials, the first of
which is in AjDA. PH94B is an investigational pherine nasal spray
with a unique potential mechanism of action designed to achieve
rapid-onset anti-anxiety effects without requiring systemic uptake
or causing benzodiazepine-like side effects and safety concerns.
The exploratory Phase 2A clinical trial of PH94B
in AjDA is a randomized, double-blind, placebo-controlled study
with an enrollment target of approximately 40 adults at clinical
sites in the Boston and New York City metro areas. Dr. Michael
Liebowitz, a Columbia University psychiatrist, former director and
founder of the Anxiety Disorders Clinic at the New York State
Psychiatric Institute, and director of the Medical Research Network
in New York City is serving as Principal Investigator of the trial.
The study’s primary outcome measure is the change from baseline in
anxiety level as measured by the Hamilton Anxiety Rating Scale
(HAM-A). Additional details about the clinical trial can be found
at www.clinicaltrials.gov, identifier NCT04404192.
“As we continue to advance ongoing Phase 3
clinical development of PH94B in our PALISADE Phase 3 Program in
Social Anxiety Disorder, we are excited to launch our Phase 2A
clinical program to explore PH94B’s potential in multiple
additional anxiety disorders with unmet need,” said Shawn Singh,
Chief Executive Officer of VistaGen. “There has been a significant
shift in mental health since early last year. Emotional stress and
impaired functioning as a result of anxiety-provoking stressors
brought on by sudden changes in health, safety, economic and social
circumstances, including the diverse impacts of the COVID-19
pandemic, have directly or indirectly affected hundreds of millions
of individuals around the world and may have led to a considerable
increase in the prevalence of Adjustment Disorder with Anxiety. We
believe the impact of the pandemic on mental health will be
long-term and varied across a wide range of anxiety disorders, and
we are committed to becoming part of the solution for people who
need to find help. Expanding on our ongoing efforts to address the
alarming prevalence of Social Anxiety Disorder, the initiation of
this exploratory Phase 2A study in Adjustment Disorder with Anxiety
is an exciting next step toward our goal.”
About
Adjustment Disorder with AnxietyAlmost 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 mayexperience 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, significantly impairing a person’s social,
occupational and/or other important area(s) of
functioning.About PH94B PH94B is a
first-in-class, odorless, rapid-onset (approximately 15 minutes)
pherine nasal spray with the potential to be the first
FDA-approved, fast-acting, on-demand acute treatment for millions
of Americans who suffer from Social Anxiety Disorder (SAD), with
additional therapeutic potential in Adjustment Disorder with
Anxiety (AjDA), Postpartum Anxiety, Procedural Anxiety,
Post-traumatic Stress Disorder, Panic Disorder and Generalized
Anxiety Disorder. Designed to be administered intranasally at
microgram doses, the proposed mechanism of action (MOA) of PH94B is
fundamentally differentiated from that of all current anti-anxiety
medications, including benzodiazepines. PH94B’s proposed MOA 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 neurons in the nasal passages,
thereby limiting transport of molecules to the circulatory system
and minimizing potential systemic exposure, suggesting that PH94B
has the potential to achieve rapid-onset anti-anxiety effects
without requiring systemic uptake or causing benzodiazepine-like
side effects and safety concerns.
Following successful Phase 2 development,
VistaGen has recently initiated two ongoing Phase 3 clinical trials
of PH94B, PALISADE-1 and PALISADE-2, to assess the efficacy, safety
and tolerability of PH94B for the acute treatment of anxiety in
adults with SAD. In addition, VistaGen’s exploratory Phase 2A
clinical program for PH94B in additional anxiety disorders is now
underway with the recent initiation of its Phase 2A clinical trial
in AjDA. The FDA has granted Fast Track designation for the
development of PH94B as a treatment for SAD. View more
background on PH94B's unique mechanism of action.
About VistaGen
Therapeutics VistaGen Therapeutics is a biopharmaceutical
company committed to developing and commercializing innovative
medicines with the potential to go beyond the current standard of
care for anxiety, depression and other CNS disorders. Each of
VistaGen's drug candidates has a differentiated potential mechanism
of action, has been well-tolerated in all clinical studies to date
and has therapeutic potential in multiple CNS markets. For more
information, please visit our website at www.VistaGen.com and
connect with VistaGen on social media - Twitter, LinkedIn,
Instagram and Facebook.
Forward
Looking StatementsVarious statements in this release are
"forward-looking statements" concerning VistaGen's future
expectations, plans and prospects, including the potential for
successful exploratory Phase 2A development of PH94B in AjDA and
Phase 3 development of PH94B for the acute treatment of anxiety in
adults with SAD. These forward-looking statements are neither
promises nor guarantees of future performance, and are subject to a
variety of risks and uncertainties which could cause actual results
to differ materially from those contemplated in these
forward-looking statements, including the risks that: completion of
the Phase 2A study in AjDA, PALISADE-1 and/or PALISADE-2 may be
delayed due to a variety of factors, including factors related to
the ongoing COVID-19 pandemic; development and approval of PH94B
may not be achieved in any market; the FDA or the Company may
decide that the results of the Phase 2A study of PH94B in AjDA, or
in PALISADE-1 and/or PALISADE-2 and other studies in the Company's
PALISADE Phase 3 Program for PH94B in SAD are not sufficient to
support further development in AjDA in the case of the Phase 2A
study, or, with respect to the PALISADE Phase 3 Program in SAD, a
U.S. New Drug Application, or for regulatory approval for the acute
treatment of anxiety in adults with SAD or any other
anxiety-related disorder, including AjDA; development of PH94B may
not be successful in any indication; success in nonclinical studies
or in earlier-stage clinical trials may not be repeated or observed
at any time during Phase 2A development in AjDA or in the PALISADE
Phase 3 Program, including during PALISADE-1 and/or PALISADE-2, or
future trials, which trials may not support further development or
be sufficient to gain regulatory approval to market PH94B; adverse
events may be encountered at any stage of development that
negatively impact further development. Other risks and
uncertainties include, but are not limited to, issues related to:
adverse healthcare reforms and changes of laws and regulations;
general industry and market conditions; manufacturing and marketing
risks, which may include, but are not limited to, unavailability of
or delays in the manufacture of PH94B; inadequate and/or untimely
supply of PH94B to meet demand; entry of competitive products; and
other technical and unexpected hurdles in the development,
manufacture and commercialization of PH94B, as well as those risks
more fully discussed in the section entitled "Risk Factors" in the
Company’s most recent Annual Report on Form 10-K for the year ended
March 31, 2021, and in its most recent Quarterly Report on Form
10-Q for the quarter ended June 30, 2021 as well as discussions of
potential risks, uncertainties, and other important factors in its
other filings with the Securities and Exchange Commission. In
addition, any forward-looking statements represent the Company's
views only as of today and should not be relied upon as
representing its views as of any subsequent date. The Company
explicitly disclaims any obligation to update any forward-looking
statements.
VistaGen
Company Contacts Media:Mark McPartland, Vice President,
Corporate DevelopmentPhone: (650) 577-3606Email:
markmcp@vistagen.com
Investors:Mark
Flather, Vice President, Investor RelationsPhone: (650)
577-3617Email: mflather@vistagen.com
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