PALISADE Phase 3 Program focused on PH94B’s
potential as a rapid-onset, acute treatment of anxiety in adults
with social anxiety disorder
FDA Fast Track designation granted
Topline results anticipated mid-2022
VistaGen Therapeutics, Inc. (Nasdaq: VTGN), 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 last patient has
completed the study protocol in its PALISADE-1 Phase 3 clinical
trial of PH94B for the acute treatment of anxiety in adults with
social anxiety disorder (SAD).
VistaGen’s PALISADE-1 Phase 3 clinical trial is a U.S.
multi-center, randomized, double-blind, placebo-controlled,
parallel design, clinical study in adults diagnosed with SAD. The
study is designed to evaluate the efficacy, safety, and
tolerability of the acute administration of PH94B to relieve
symptoms of anxiety in adult patients living with SAD during a
simulated public speaking challenge conducted in a clinical
setting, measured using the Subjective Units of Distress Scale
(SUDS). Topline results from VistaGen’s PALISADE-1 Phase 3 clinical
study are anticipated in mid-2022, consistent with the Company’s
prior guidance.
“We would like to thank the many individuals currently living
with social anxiety disorder who participated in PALISADE-1, as
well as Dr. Michael Liebowitz, the Principal Investigator in the
study and a leading expert in SAD, the clinical site investigators
and their teams, and our CRO. Together with our internal team, all
are an integral part of our PALISADE Phase 3 Program for PH94B.
Social anxiety disorder affects an estimated 25 million individuals
in the United States, and this milestone further reflects our
Company’s continuing commitment to develop novel treatment options
with potential to go beyond the current standard of care for
widespread mental health disorders,” said Shawn Singh, Chief
Executive Officer of VistaGen.
VistaGen is also evaluating PH94B for SAD in a second Phase 3
clinical trial, PALISADE-2, a U.S. multi-center, randomized,
double-blind, placebo-controlled Phase 3 clinical trial designed as
a replicate of PALISADE-1 to evaluate the efficacy, safety, and
tolerability of PH94B for the acute treatment of anxiety in adults
with SAD. Topline results from PALISADE-2 are anticipated in
late-2022.
PALISADE Phase 3 Program for PH94B in Social Anxiety
Disorder
VistaGen’s PALISADE Phase 3 Program in social anxiety disorder
(SAD) is designed to further demonstrate the potential of PH94B as
a fast-acting, acute treatment of anxiety in adults with SAD. The
Company’s PALISADE-1 and PALISADE-2 Phase 3 clinical trials are
replicate U.S. multi-center, randomized, double-blind,
placebo-controlled Phase 3 clinical trials designed to evaluate the
efficacy, safety, and tolerability of PH94B for the acute treatment
of anxiety in adults with SAD. If the Company’s PALISADE Phase 3
Program is successful, then VistaGen plans to submit a New Drug
Application (NDA) to the U.S. Food and Drug Administration (FDA) to
approve the use of PH94B for the acute treatment of anxiety in
adults with SAD. The FDA has granted Fast Track designation for the
development of PH94B for SAD.
About Social Anxiety Disorder
Social anxiety disorder (SAD) affects an estimated 25 million
Americans. A person with SAD feels intense, persistent symptoms of
anxiety or fear in certain social situations, such as meeting new
people, making comments in a business meeting, 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 embarrassed,
evaluated, humiliated, 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 is likely to involve interpersonal
interaction. It can lead to avoidance and opportunity costs that
can significantly impact a person's employment and social
activities and be very disruptive to their overall quality of life.
SAD is commonly treated long-term with certain FDA-approved
antidepressants, which have a slow onset of effect (several weeks)
and provide limited therapeutic benefits, and benzodiazepines,
which are not FDA-approved for the treatment of SAD. Both
antidepressants and benzodiazepines have known side effects and
significant safety concerns that may make them unattractive to
individuals affected by SAD.
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, for the
acute treatment of anxiety in adults with SAD. 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.
VistaGen’s proposed MOA for PH94B does not involve either direct
activation of GABA-A receptors or binding to neuronal receptors in
the central nervous system (CNS). Rather, PH94B’s proposed MOA
involves binding to receptors in 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. VistaGen is conducting a Phase 2A clinical trial
to evaluate the potential use of PH94B to treat adjustment disorder
with anxiety and is considering the evaluation of PH94B for
potential use in the treatment of other anxiety-related disorders,
including procedural anxiety, post-traumatic stress disorder
(PTSD), postpartum anxiety, and panic disorder.
About VistaGen
VistaGen (Nasdaq: VTGN) is a late clinical-stage, central
nervous system (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. PH94B and PH10
belong to a new class of drugs known as pherines, which are
odorless, tasteless, neuroactive steroids designed to bind to
distinct receptors on chemosensory neurons in the nasal passages
and can impact the limbic amygdala with rapid-onset and 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 topline
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 the completion and results of the Company’s PALISADE-1
and PALISADE-2 Phase 3 clinical trials; the Company’s ability to
submit a NDA to the FDA following the completion of PALISADE-1
and/or PALISADE-2 Phase 3 clinical trials; 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; 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220622005431/en/
Investors Mark Flather Vice President, Investor
Relations, VistaGen Therapeutics Phone: (650) 577-3617 Email:
mflather@vistagen.com
Media Nate Hitchings SKDK nhitchings@skdknick.com
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