First positive U.S. Phase 3 study of an
investigational therapy for social anxiety disorder in over 15
years
Statistically significant rapid-onset reduction
in patient-reported Subjective Units of Distress Scale (SUDS) score
compared to placebo in a public speaking challenge (primary
endpoint, p=0.015)
Trial also met the secondary endpoint,
demonstrating a statistically significant reduction in proportion
of responders compared to placebo as measured by the Clinical
Global Impressions Improvement (CGI-I) scale (secondary endpoint,
p=0.033)
Fasedienol was well-tolerated and demonstrated
a favorable safety profile consistent with all prior trials of
fasedienol in social anxiety disorder
Over 25 million Americans are living with
social anxiety disorder1
Vistagen (NASDAQ: VTGN), a clinical-stage biopharmaceutical
company aiming to transform the treatment landscape for individuals
living with anxiety, depression and other central nervous system
(CNS) disorders, today announced positive top-line results from its
Phase 3 PALISADE-2 trial evaluating the efficacy, safety, and
tolerability of fasedienol (PH94B) nasal spray in adults diagnosed
with social anxiety disorder (SAD). The trial met its primary
endpoint, with fasedienol demonstrating a statistically significant
difference in average SUDS score during a public speaking challenge
compared to placebo (p=0.015). The trial also met its secondary
endpoint, demonstrating a statistically significant difference in
the proportion of clinician-assessed responders between fasedienol
and placebo as measured by the CGI-I scale (p=0.033). Fasedienol
was well-tolerated and demonstrated a favorable safety profile
consistent with all prior trials.
“We are thrilled that these compelling top-line results from the
Phase 3 PALISADE-2 trial confirm what was seen in the Phase 2
studies in social anxiety disorder and highlight the potential for
fasedienol, with its novel and unique proposed mechanism of action,
to transform what is possible for more than 25 million people
living with social anxiety in the U.S. and millions more affected
worldwide,” stated Shawn Singh, Chief Executive Officer of
Vistagen. “As a new class of medicines, our pherine nasal spray
pipeline holds the potential to transform the treatment landscape
across numerous therapeutic areas. At the head of that class,
fasedienol’s potential, as demonstrated in this Phase 3 trial, sets
the stage for the first fundamentally new class of medicine for
individuals living with SAD in more than 20 years.”
“Fasedienol demonstrated a rapid and very clinically meaningful
reduction in SUDS score, indicating a single administration has the
potential to reduce anxiety symptoms during an anxiety-provoking
situation,” stated Dr. Michael R. Liebowitz, innovator of the
Liebowitz Social Anxiety Scale (LSAS), former Columbia University
psychiatrist, director and founder of the Anxiety Disorders Clinic
at the New York State Psychiatric Institute, and current Managing
Director of The Medical Research Network LLC in New York City. “A
future Phase 3 study involving multiple administrations of
fasedienol over several weeks on a patient-tailored, as-needed
basis will build on the body of evidence now demonstrated in
PALISADE-2 and multiple Phase 2 studies. Fasedienol could be an
optimal treatment for social anxiety patients given its ability to
be used acutely to reduce anxiety while helping to reduce SAD
severity over time.”
Primary Efficacy Endpoint
The PALISADE-2 trial (n=141) met its primary efficacy endpoint,
the difference in mean SUDS score during the public speaking
challenge at baseline (Visit 2) and treatment (Visit 3) for
patients who received fasedienol (n=70) compared to placebo (n=71)
at Visit 3. Fasedienol-treated patients demonstrated a
statistically significant greater change in mean SUDS score
(least-squares (LS) mean = -13.8) compared to placebo (LS mean =
-8.0), for a difference between groups of -5.8 (p=0.015).
Secondary Efficacy Endpoint
The trial met its secondary endpoint, demonstrating a
statistically significant difference in the proportion of
clinician-assessed responders between fasedienol and placebo as
measured by the CGI-I scale. Responders were identified as those
who were rated ‘very much less anxious’ or ‘much less anxious’ with
37.7% (n=70) of fasedienol-treated patients rated as responders, as
compared to 21.4% (n=71) of those treated with placebo
(p=0.033).
Exploratory Efficacy Endpoints
The trial met an important exploratory endpoint of the
difference in the proportion of patient-assessed responders between
fasedienol and placebo as measured by the Patient’s Global
Impression of Change (PGI-C) scale. Responders were identified as
those who self-rated ‘very much less anxious’ or ‘much less
anxious’ with 40.6% (n=70) of fasedienol-treated patients rated as
responders, as compared to 18.6% (n=71) of those treated with
placebo (p=0.003).
The trial also met the exploratory endpoint of the difference in
the proportion of patients in each treatment group with a 20-point
improvement in patient-assessed SUDS score from baseline (Visit 2)
to treatment (Visit 3). Of the fasedienol-treated patients, 35.7%
(n=70) demonstrated this statistically significant and clinically
meaningful improvement in SUDS score, as compared to 18.6% (n=71)
in the placebo-treated group (p=0.020).
Safety
Fasedienol was observed to be well-tolerated in the study with
no severe or serious adverse events (AEs) reported. All
treatment-emergent adverse events reported for the overall study
were mild or moderate. There were no AEs reported in the fasedienol
treatment arm above 2% occurrence.
About the Phase 3 PALISADE-2 Trial
PALISADE-2 was a multi-center, randomized, double-blind,
placebo-controlled, Phase 3 clinical study in adults diagnosed with
SAD. The study was designed to evaluate the efficacy, safety, and
tolerability of the acute administration of fasedienol to relieve
anxiety symptoms in adult patients with SAD during a simulated
anxiety-provoking public speaking challenge, as measured using the
patient-reported SUDS score.
Enrolled patients had a diagnosis of SAD and demonstrated marked
social anxiety at enrollment, as evidenced by a baseline score on
the LSAS of at least 70. A total of 141 patients were enrolled in
the U.S. multi-center trial. The total enrollment reflects the
pause in enrollment after receiving top-line results from
PALISADE-1 to allow for independent third-party biostatisticians to
conduct an interim analysis of the 141 patients randomized in the
trial up to the date of the pause. Although the results of the
independent interim analysis indicated that continuation of
PALISADE-2 would not be futile, Vistagen determined the best course
of action was to close the PALISADE-2 study given the expense, time
and methodological complexities involved in resuming
PALISADE-2.
Additional analysis of data from the Phase 3 PALISADE-2 trial is
ongoing, with plans to present these results at future scientific
meetings.
About Fasedienol Nasal Spray
Vistagen’s fasedienol (PH94B) is a first-in-class, rapid-onset
investigational pherine nasal spray with a novel proposed 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, without systemic
distribution, potentiation of GABA-A receptors or direct activity
on neurons in the brain. Vistagen is developing fasedienol in a
Phase 3 program for the treatment of social anxiety disorder.
Designed for intranasal administration in low microgram doses, the
proposed novel MOA of fasedienol is fundamentally differentiated
from all currently approved anti-anxiety medications, including all
SSRIs and SNRIs as well as benzodiazepines prescribed
off-label.
About Social Anxiety Disorder
Social anxiety disorder (SAD) affects over 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 can 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 with benzodiazepines, which are not
FDA-approved for treating SAD. Both antidepressants and
benzodiazepines have known side effects and significant safety
concerns that may make them unattractive to individuals affected by
SAD.
About Vistagen
Vistagen (Nasdaq: VTGN) is a late clinical-stage
biopharmaceutical company aiming to transform the treatment
landscape for individuals living with anxiety, depression and other
CNS disorders. Vistagen is advancing therapeutics with the
potential to be faster-acting, and with fewer side effects and
safety concerns, than those currently available for the treatment
of anxiety, depression and multiple CNS disorders. Vistagen’s
pipeline includes six clinical-stage product candidates, including
fasedienol (PH94B), itruvone (PH10), PH15, PH80, and PH284, each an
investigational agent belonging to a new class of drugs known as
pherines, as well as AV-101, which is an oral prodrug antagonist of
the N-methyl-D-aspartate receptor. Pherines are administered as low
microgram dose level nasal sprays and are designed with a novel
mechanism of action that activates chemosensory neurons in the
nasal cavity and can beneficially impact key neural circuits in the
brain without systemic uptake or direct activity on CNS neurons in
the brain. Vistagen is passionate about transforming mental health
care and redefining what is possible in the treatment of anxiety,
depression and several other CNS disorders. 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. As with all pharmaceutical products,
there are substantial risks and uncertainties in the process of
development and commercialization and actual results or development
may differ materially from those projected or implied in these
forward-looking statements. Among other things, there can be no
guarantee that any of Vistagen’s product candidates will
successfully complete ongoing or future clinical trials,
successfully replicate the results of past clinical trials
(including PALISADE-2), receive regulatory approval or be
commercially successful. Other factors that may cause such a
difference include, without limitation, risks and uncertainties
relating to Vistagen’s ability to secure adequate financing for its
operations, including financing or collaborative support for
continued clinical development of fasedienol and/or other product
candidates; the completion and results of Vistagen’s ongoing and/or
future clinical studies for any of Vistagen’s product candidates;
other risks and uncertainties related to delays in launching,
conducting and/or completing ongoing and planned clinical trials;
the scope and enforceability of Vistagen’s patents; fluctuating
costs of materials and other resources and services required to
conduct Vistagen’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;
and other technical and unexpected hurdles in the development,
manufacture and commercialization of Vistagen’s CNS drug
candidates. These risks are more fully discussed in the section
entitled "Risk Factors" in Vistagen’s most recent Annual Report on
Form 10-K for the fiscal year ended March 31, 2023, 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). Vistagen’s SEC filings are available on the SEC’s
website at www.sec.gov. Additionally, you should not place undue
reliance on these forward-looking statements in the future, because
they apply only as of the date of this press release and should not
be relied upon as representing Vistagen’s views as of any
subsequent date. Vistagen explicitly disclaims any obligation to
update any forward-looking statements, other than as may be
required by law. If Vistagen does update one or more
forward-looking statements, no inference should be made that
Vistagen will make additional updates with respect to those or
other forward-looking statements.
1 2021 National Health and Wellness Survey
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version on businesswire.com: https://www.businesswire.com/news/home/20230807764660/en/
Investors Mark McPartland Senior Vice President, Investor
Relations (650) 577-3606 markmcp@vistagen.com
Media Nate Hitchings SKDK nhitchings@skdknick.com
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