Long-term intranasal administration of
fasedienol, used as-needed up to four times a day in daily life,
was safe and well-tolerated in nearly 500 patients with social
anxiety disorder (SAD)
Patients self-administered over 30,000 doses of
fasedienol in real-world settings, with a mean study duration of 4
months, and a maximum study duration of over 10 months
Fasedienol demonstrated clinically meaningful
reductions in fear, anxiety and avoidance of anxiety-provoking
social and performance situations in daily life, as measured by the
Liebowitz Social Anxiety Scale (LSAS), building on LSAS data from a
previous placebo-controlled Phase 2 study of fasedienol in SAD
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
positive data from its Phase 3 open-label study designed to
evaluate the safety and tolerability of multiple, as-needed
intranasal administrations of fasedienol (PH94B) over time in
adults with social anxiety disorder (SAD). For the primary endpoint
of safety and tolerability (safety population: n=481), the
long-term administration of 3.2 µg of fasedienol, up to four times
a day, as-needed, was safe and well-tolerated, with no new safety
findings or trends identified, regardless of the number of doses
administered by each subject. Secondary endpoints in the study
included evaluation of the change from baseline on the Liebowitz
Social Anxiety Scale (LSAS), which measures SAD patients’ response
to anxiety-provoking social and performance situations experienced
in their daily lives. Analysis of the final data set demonstrates
clinically meaningful functional improvement, as measured by the
LSAS, and total LSAS scores continued to decline in consecutive
months during the study.
The safety and exploratory LSAS results of this Phase 3 open
label study build on the safety and LSAS efficacy results from a
previous randomized, double-blind, placebo-controlled Phase 2 study
of fasedienol in a real-world setting. Results from that study
suggested that self-administration of fasedienol on an as-needed
basis prior to anxiety-provoking situations was accompanied by a
persistent change in overall SAD symptoms, reduction in fear and
anxiety, and less frequent avoidance, as measured by the LSAS over
the course of fasedienol usage. Notably, in the placebo-controlled
Phase 2 study, the amount of separation between fasedienol and
placebo at the end of the first 2 weeks on the LSAS was comparable
to what was observed after 12 weeks in the registration trials for
the three medications currently approved by the FDA for the
treatment of SAD, two SSRIs and one SNRI. All prior registration
studies for these medications were positive, and all studies used
the LSAS as the primary efficacy endpoint.
“The safety profile and potential for fasedienol to achieve
overall reduction in symptoms of SAD and improvement in severity of
the disorder, as measured by the LSAS, have now been demonstrated
in a placebo-controlled Phase 2 study after two weeks of use, as
well as in this open-label study over a period of one month and
beyond,” said Shawn Singh, Chief Executive Officer of Vistagen. “We
believe these data suggest that studies involving multiple
administrations of fasedienol over time, on an as-needed basis at
moments when subjects experience real-life, socially stressful
situations, most accurately demonstrate the safety and efficacy
potential of fasedienol in patients with SAD and reflect the way we
believe fasedienol would be used by SAD patients, if approved. Each
SAD patient is unique, and we believe an optimal SAD treatment is
one that is individualized and tailored-to-fit by patients,
as-needed, to help them engage in the anxiety-provoking situations
they encounter in their daily lives with less fear and
anxiety.”
Study Details
The fasedienol Phase 3 open-label study was designed to evaluate
the safety and tolerability of multiple, as-needed intranasal
administrations (up to four times a day) of fasedienol in adults
with SAD. The study also evaluated the change from baseline in
monthly standard clinical measurements and behavioral assessment
scales (LSAS, CGI-S, CGI-I and PGI-C) in response to
anxiety-provoking social situations in their daily lives after the
administration of fasedienol. Safety and tolerability of fasedienol
were assessed and summarized during monthly visits from baseline to
end of treatment in adverse events (AEs), laboratory values,
12-lead electrocardiograms (ECGs), physical examinations, and vital
sign assessments following exposure to fasedienol. The study was
closed early due to business reasons. At the time of study closure,
study participants had a mean trial exposure of 120 days and a
maximum exposure of 320 days.
Safety Results
- The long-term intranasal administration of 3.2 µg of
fasedienol, up to four times a day, as-needed, was safe and
well-tolerated in adult SAD patients (n=481).
- Of the 481 SAD patients in the study who received at least one
dose of fasedienol, at least one treatment-emergent adverse event
(TEAE) was reported by 56.8% of subjects, with 54.9% of the 481
patients reporting mild or moderate TEAEs and only 1.9% of patients
reporting severe TEAEs.
- Headache was the most common 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.
- Fourteen patients (2.9%) experienced a TEAE leading to
discontinuation from the study.
- Six patients (1.2%) experienced a treatment-emergent serious
adverse event, none of which were considered related to
fasedienol.
Exploratory Efficacy Results
Liebowitz Social Anxiety Scale
- At 1 month, mean reduction on the LSAS was 16 points, with 36%
experiencing a 20‑point or greater reduction (n=385).
- At 2 months, mean reduction on the LSAS was 20 points, with 44%
experiencing a 20‑point or greater reduction (n=324).
- At 3 months, mean reduction on the LSAS was 24 points, with 55%
experiencing a 20‑point or greater reduction, and with 36%
experiencing a 30‑point or greater reduction (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 9 months. The continued improvement in
LSAS scores is indicative of the value of multiple, as-needed
administrations of fasedienol over time.
Clinician-rated Severity and Improvement
At baseline, half (50.3%) of the 481 SAD patients assessed in
the study were rated as “severely ill” or “among the most extremely
ill patients” on the Clinician Global Impression – Severity of
Illness Scale (CGI-S). After one month, 21.8% of the 385 patients
assessed remained in that category. The Clinician Global Impression
of Improvement (CGI-I) indicated 28.6% of the 385 patients assessed
after one month were “much” or “very much” improved.
Patient-rated Improvement
The Patient Global Impression of Change (PGI-C) indicated 26.8%
of the 385 patients assessed after one month considered themselves
“much” or “very much” improved. Importantly, the data show good
congruence between clinician and patient assessments of
improvement. Moreover, both clinician-observed (CGI-I) and
patient-rated improvements (PGI-C) support the data shown by the
reduction in LSAS scores, indicating that the LSAS is a clinically
useful tool for measuring the severity of SAD.
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 or direct activity on CNS
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 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. 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 for
treatment of anxiety and depression disorders. Several of
Vistagen’s product candidates belong to a new class of drugs known
as pherines, which are designed with a novel rapid-onset mechanism
of action that activates chemosensory neurons in the nasal passages
and can beneficially impact key neural circuits 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 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. As with all pharmaceutical products,
there are substantial risks and uncertainties in the process of
development and commercialization and actual results or
developments 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,
including fasedienol (PH94B) and/or itruvone (PH10), or any other
pherine drug candidate will successfully complete ongoing or future
clinical trials, receive regulatory approval or be commercially
successful. These risks, along with additional 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. 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/20230322005351/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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