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 its PALISADE Phase 3
clinical program with the PALISADE-1 Phase 3 trial, a randomized,
double-blind, placebo-controlled study to evaluate the efficacy and
safety of PH94B for the acute treatment of anxiety in adults with
Social Anxiety Disorder (SAD). PH94B is an odorless, rapid-onset,
investigational pherine nasal spray with a unique mechanism of
action, working differently than all existing therapies for SAD.
There is currently no U.S. Food and Drug Administration (FDA)
approved acute treatment of anxiety for adults with SAD.
PALISADE-1 is being conducted across
approximately 18 sites in the U.S., with a target of approximately
200 randomized subjects. Dr. Michael Liebowitz, a Columbia
University psychiatrist, former director and founder of the Anxiety
Disorders Clinic at the New York State Psychiatric Institute,
director of the Medical Research Network in New York City, and
creator of the Liebowitz Social Anxiety Scale (LSAS), is serving as
Principal Investigator of the trial. Topline results from
PALISADE-1 are anticipated in mid-2022.
“Initiation of PALISADE-1 is a major milestone
for our PALISADE Phase 3 clinical program for PH94B, a program
aimed at supporting a potential New Drug Application to the FDA.
The trial is an essential next step in our efforts to confirm the
positive efficacy and safety results we have seen in all PH94B
Phase 2 trials to date,” stated Shawn Singh, Chief Executive
Officer of VistaGen. “PH94B has the potential to be a life-changing
acute, as-needed treatment of anxiety for adults with SAD, similar
to how a rescue inhaler is used to prevent an asthma attack. At a
time of continuing increase in the number of Americans suffering
from SAD and other anxiety disorders, and a current treatment
paradigm that falls short of delivering necessary relief, a new
fast-acting treatment alternative is imperative. Initiation of our
PALISADE-1 trial further reflects our commitment to go beyond the
current standard of care for SAD. If successfully developed, PH94B
has the potential to be the first fast-acting, non-systemic,
non-sedating acute treatment of anxiety for more than 23 million
Americans who suffer from SAD.”
“Social Anxiety
Disorder is the third most common mental health disorder among
Americans, and it can turn everyday social interactions into
debilitating, fearful experiences for people who continue to suffer
from this growing mental health condition,” said Dr. Liebowitz.
“Existing treatments, such as approved antidepressants, have not
been effective acute treatment solutions for this large patient
population. In addition, the negative side effects and safety
concerns associated with benzodiazepines prescribed off-label are a
significant cause for concern, as demonstrated by the FDA’s Drug
Safety Communication detailing the risks of benzodiazepines issued
last Fall. The start of this Phase 3 trial is a major step forward
in the clinical development of PH94B, an investigational drug with
the potential to displace antidepressants and benzodiazepines in
the treatment paradigm for SAD, as well as several other anxiety
disorders.”
PH94B Phase 2 Study Results –
Public Speaking ChallengeThe PALISADE-1 Phase 3 trial
design is substantially based upon the design of the
laboratory-simulated public speaking challenge in the Phase 2
multi-center, randomized, double-blind, placebo-controlled trial of
PH94B for the acute treatment of anxiety in adults with SAD. In
that Phase 2 study, PH94B rapidly reduced (within 15 minutes)
anxiety in response to both the public speaking challenge (p=0.002)
and a social interaction challenge (p=0.009).
About Social Anxiety Disorder
(SAD)Social Anxiety Disorder affects as many as 23.7
million Americans and, according to the National Institutes of
Health, is the third most common psychiatric condition after
depression and substance use. A person with SAD feels intense,
persistent symptoms of anxiety or fear in certain social
situations, such as meeting new people, dating, being on a job
interview, answering a question in class, or talking to a cashier
in a store. Doing common, everyday things in front of people causes
profound anxiety or fear of being humiliated, evaluated, judged, or
rejected. SAD can get in the way of going to work, attending
school, or doing a wide variety of things in a situation that has
the potential for interpersonal interaction. It can lead to
avoidance and opportunity cost that can significantly impact a
person's employment and social activities and be very disruptive to
overall quality of life. SAD is commonly treated chronically with
certain FDA-approved antidepressants, which have a slow onset of
effect (several weeks) and limited therapeutic benefits, and
benzodiazepines, which are not FDA-approved for treatment of SAD
but are prescribed for off-label use. Both antidepressants and
benzodiazepines have known side effects and safety concerns that
may make them unattractive to individuals affected by SAD.
About PH94BPH94B is a first-in-class,
odorless, rapid-onset (approximately 10 to 15 minutes) CNS pherine
nasal spray with the potential to be the first FDA-approved,
fast-acting, on-demand treatment for millions of Americans who
suffer from SAD, with additional potential in adjustment disorder,
postpartum anxiety, pre-procedural anxiety, post-traumatic stress
disorder, panic disorder and generalized anxiety disorder.
Administered at microgram doses, PH94B activates nasal chemosensory
neurons that trigger neural circuits in the brain that suppress
fear and anxiety. Following successful Phase 2 development,
VistaGen has recently initiated its PALISADE-1 Phase 3 clinical
trial of PH94B for acute treatment of anxiety in adults with SAD.
The FDA has granted Fast Track designation for the development of
PH94B as a treatment for SAD. View more background on SAD and
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 www.VistaGen.com and connect with
VistaGen on Twitter, LinkedIn 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 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:
development and approval of PH94B may not be achieved in any
market; the FDA may decide that the results of the PALISADE-1 trial
and the Company's PALISADE PH94B Phase 3 clinical program are not
sufficient to support a New Drug Application, or for regulatory
approval for the acute treatment of anxiety in adults with SAD or
any other anxiety-related disorder; 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 the PALISADE Phase 3 program, including during
PALISADE-1, 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 delivery of raw materials for 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, 2020, and in its most recent
Quarterly Report on Form 10-Q for the quarter ended December 31,
2020 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
ContactsMark McPartland / Mark FlatherVistaGen
Therapeutics Phone: (650) 577-3606Email: IR@vistagen.com
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