Favorable long-term, open-label treatment data
from nearly 500 patients in real-world setting suggest that
patient-tailored, as-needed administrations of fasedienol over time
were safe and well-tolerated
Positive exploratory fasedienol efficacy data
measured by the Liebowitz Social Anxiety Scale (LSAS) demonstrated
clinically meaningful reductions in fear, anxiety and avoidance of
anxiety-provoking social and performance situations in daily life,
building on LSAS data from a previous real-world,
placebo-controlled Phase 2 study of fasedienol in social anxiety
disorder
Vistagen (Nasdaq: VTGN), a late 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 that positive safety and
exploratory efficacy data from its large Phase 3 open-label study
of fasedienol (PH94B) nasal spray for the treatment of anxiety in
adults with social anxiety disorder (SAD) were presented in a
late-breaking poster presentation at the American Society for
Clinical Psychopharmacology (ASCP) 2023 Annual Meeting taking place
in Miami from May 30 through June 2, 2023.
The study was conducted in a real-world setting and was designed
to evaluate the long-term safety and tolerability of multiple,
patient-tailored, as-needed administrations of fasedienol in adults
with SAD when they experienced social and performance stressors in
their daily lives.
Safety
Long-term administration of 3.2 µg of fasedienol, as-needed up
to four times per day, was safe and well-tolerated, with no new
safety findings or trends identified, regardless of the number of
doses administered by each subject (safety population: n=481), as
previously reported. Headache was the most common
treatment-emergent adverse event (TEAE) (17.0%); no other TEAE
occurred in more than 5.0% of subjects, except for COVID-19 TEAEs
(11.4%), which were not considered related to fasedienol. Over
30,000 doses of fasedienol were administered by patients during the
study.
Exploratory Efficacy
The study also evaluated the change from baseline in monthly
standard clinical measurements and behavioral assessment scales
(the LSAS, Clinician Global Impression of Improvement scale (CGI-I)
and Patient Global Impression of Change scale (PGI-C)) in response
to anxiety-provoking social and performance situations in patients’
daily lives after the administration of fasedienol.
LSAS Improvement
The key exploratory endpoint in the study included evaluation of
the change from baseline on the LSAS, which measures SAD patients’
response to anxiety-provoking social and performance situations
experienced in their daily lives. The LSAS was the primary efficacy
endpoint in all registration studies for the three FDA-approved
treatments for adults with SAD.
As presented in the poster, analysis of the final data set from
the study demonstrates clinically meaningful functional
improvement, as measured by the LSAS, and total LSAS scores, in
both men and women, continued to decline in consecutive months
during the study, as follows:
- After 1 month, the mean reduction on the LSAS was 16 points
(n=385);
- After 2 months, the mean reduction on the LSAS was 20 points
(n=324); and
- After 3 months, the mean reduction on the LSAS was 24 points
(n=218).
For subjects who continued in the study, total LSAS scores
continued to decline from baseline, with improvements observed each
month on the LSAS through nine months. The continued improvement in
LSAS scores is indicative of the therapeutic potential of multiple,
patient-tailored, as-needed administrations over time as fasedienol
helps patients build confidence to engage in anxiety-provoking
social and performance situations in their daily lives more
frequently and with less fear and anxiety.
Clinician-rated Improvement
The CGI-I results indicated 43% of the 218 patients assessed
after three months were “much” or “very much” improved.
Patient-rated Improvement
The PGI-C results indicated 44% of the 218 patients assessed
after three months considered themselves “much” or “very much”
improved.
“These data advance the body of evidence supporting fasedienol’s
safety profile and potential to achieve overall reduction in
anxiety for adults suffering with social anxiety disorder, and we
were excited to present these important findings to the ASCP
community. There are significant gaps in care for mental health
patients, and many are seeking fast-acting medications with a
favorable safety profile,” said Shawn Singh, Chief Executive
Officer of Vistagen. “When used as-needed and over time in their
daily lives, as in this open-label study and a prior
placebo-controlled Phase 2 study, we believe fasedienol, with its
exceptional safety profile has the potential to help change the
treatment landscape for social anxiety disorder."
The abstract of the poster is currently available at the ASCP
Annual Meeting website and the full poster will be available at
https://www.vistagen.com/publication after the conclusion of the
conference on June 2, 2023.
About Fasedienol (PH94B)
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
antidepressants and benzodiazepines.
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 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 that are currently available for
treatment of anxiety, depression and multiple CNS disorders.
Vistagen’s pipeline includes six clinical-stage product candidates,
including five investigational agents belonging to a new class of
drugs known as pherines, in addition to AV-101, an oral antagonist
of the glycine site of the N-methyl-D-aspartate receptor (NMDAR).
Pherines, which are administered as nasal sprays, are designed with
an innovative rapid-onset mechanism of action that activates
chemosensory neurons in the nasal passages and can selectively and
beneficially impact key neural circuits in the brain without
requiring systemic uptake or direct activity on CNS neurons.
Vistagen’s AV-101 inhibits activity of the ion channel of the NMDAR
but does not block it. 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 the Company’s drug candidates will
successfully complete ongoing or future clinical trials, receive
regulatory approval or be commercially successful. Other factors
that may cause such a difference include, without limitation, risks
and uncertainties relating to the Company’s ability to secure
adequate financing for its operations, including financing or
collaborative support for continued clinical development of
fasedienol (PH94B) and/or other product candidates; the completion
and results of the Company’s ongoing and/or future clinical studies
of itruvone (PH10) and AV-101; other risks and uncertainties
related to delays in launching, conducting and/or completing
ongoing and planned clinical trials; the scope and enforceability
of the Company’s patents; fluctuating costs of materials and other
resources and services 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; and other technical and
unexpected hurdles in the development, manufacture and
commercialization of the Company’s CNS drug candidates. These risks
are 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, 2022, and in the Company’s most recent
Quarterly Report on Form 10-Q for the quarter ended December 31,
2022, 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. 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
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230601005454/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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