Full Press Release Details
VistaGen Therapeutics Initiates PALISADE Phase 3 Trial of PH94B in
Social Anxiety Disorder
PALISADE Phase 3 Program focused on acute treatment of anxiety in
adults with Social Anxiety Disorder
FDA Fast Track designation granted
Topline results anticipated in mid-2022
SOUTH SAN FRANCISCO, Calif., May 26, 2021
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
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
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
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
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
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
About Social Anxiety Disorder (SAD)
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.
PH94B 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