SOUTH SAN FRANCISCO, Calif.,
July 23, 2020 /PRNewswire/
-- VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical
company developing new generation medicines for anxiety, depression
and other central nervous system (CNS) disorders,
announced the results of a positive meeting with the U.S.
Food and Drug Administration (FDA) regarding Phase 3
development of PH94B for the acute treatment of anxiety in adult
patients with social anxiety disorder (SAD).
VistaGen and the FDA reached consensus on key aspects of a
unique initial pivotal Phase 3 clinical trial of PH94B involving a
single-event, laboratory-simulated public speaking challenge in
adult patients with SAD.
PH94B is an investigational rapid-onset neurosteroid nasal spray
that is fundamentally differentiated from all FDA-approved
treatments for anxiety disorders. According to the U.S. National
Institute of Mental Health (NIMH), there are approximately 17
million adults in the U.S. with SAD.
"Much like a rescue inhaler is used in an asthma attack or a
migraine drug is used in an acute migraine episode, PH94B is a
potential fit for the acute treatment of anxiety symptoms in
anticipation of an often predictable, anxiety-provoking situation
for individuals suffering from SAD," said Shawn Singh, Chief Executive Officer of
VistaGen.
"Notably, the FDA concurred that our initial pivotal Phase 3
efficacy study may be conducted in a manner substantially similar
to the highly statistically significant Phase 2 study of PH94B,
which study involved a single event, laboratory-simulated public
speaking challenge in adult patients with SAD. The FDA's specific
guidance will enable us to simplify the process of assessing
efficacy among SAD patients in our Phase 3 studies and contribute
to significant time- and cost-efficiency in the clinic," Singh
added.
Key Aspects of Consensus with FDA Regarding the Initial
Pivotal Phase 3 Study of PH94B
VistaGen's initial pivotal Phase 3 study of PH94B for acute
treatment of anxiety in adult patients with SAD will be a
randomized, double-blind, placebo-controlled, parallel comparison
study conducted at approximately 12 to 15 sites in North America.
Dr. Michael Liebowitz, Professor
of Clinical Psychiatry at Columbia
University, director of the Medical Research Network in
New York City, and creator of the
Liebowitz Social Anxiety Scale (LSAS), will be the Principal
Investigator of the study. Target enrollment will be approximately
182 adult patients with SAD.
As in the successful Phase 2 study of PH94B in SAD, the study
will involve a single laboratory-simulated anxiety-provoking public
speaking challenge. The Subjective Units of Distress Scale (SUDS)
will be used to assess the primary efficacy endpoint in the
study.
About PH94B
PH94B is a first-in-class, odorless, rapid-onset (within
approximately 15 minutes) synthetic neurosteroid nasal spray with
therapeutic potential across a broad range of anxiety-related
disorders. Easily self-administered in microgram-level doses, PH94B
does not require systemic uptake and distribution to produce its
rapid-onset anti-anxiety effects.
VistaGen is preparing for Phase 3 clinical development of PH94B
as a potential new generation fast-acting, non-sedating,
non-addictive acute treatment of anxiety in adults with social
anxiety disorder (SAD). The FDA has granted Fast Track designation
for development of PH94B for this indication, the first such
designation by the FDA for a drug candidate for SAD.
With its rapid-onset pharmacology, lack of systemic exposure and
excellent safety profile in earlier studies, PH94B has potential as
a novel treatment for multiple anxiety-related disorders.
VistaGen is also preparing for Phase 2A development of PH94B for
adjustment disorder related to the diverse impact of the COVID-19
pandemic. View more background information on SAD and a video on
PH94B's mechanism of action.
About VistaGen
VistaGen Therapeutics is a clinical-stage biopharmaceutical
company developing new generation medicines for anxiety, depression
and certain CNS diseases and disorders where current treatments are
inadequate, resulting in high unmet need. Each of VistaGen's three
drug candidates has a differentiated mechanism of action, an
exceptional safety profile, and therapeutic potential in several
large global CNS markets. For more information, please
visit www.vistagen.com and connect with VistaGen on
Twitter, LinkedIn and Facebook.
Forward-Looking Statements
Various statements in this release are "forward-looking
statements" concerning VistaGen's future expectations, plans and
prospects, including the potential for successful New Drug
Application (NDA)-enabling Phase 3 development of PH94B. These
forward-looking statements are neither promises nor guarantees of
future performance, and are subject to a variety of risks and
uncertainties which could cause actual results to differ materially
from those contemplated in these forward-looking statements,
including the risks that: development and approval of PH94B may not
be achieved in any market; the FDA may decide that the results of
the Company's PH94B Phase 3 clinical program are not sufficient for
regulatory approval for acute treatment of anxiety in adult
patients with SAD or any other anxiety-related disorder;
development of PH94B may not be successful in any indication;
success in nonclinical studies or in earlier-stage clinical trials
may not be repeated or observed in future studies which may not
support further development or be sufficient to gain regulatory
approval to market PH94B; adverse events may be encountered at any
stage of development that negatively impact further development.
Other risks and uncertainties include, but are not limited to,
issues related to: adverse healthcare reforms and changes of laws
and regulations; general industry and market conditions;
manufacturing and marketing risks, which may include, but are not
limited to, unavailability of or delays in delivery of raw
materials for manufacture of PH94B; inadequate and/or untimely
supply of PH94B to meet demand; entry of competitive products; and
other technical and unexpected hurdles in the development,
manufacture and commercialization of PH94B, as well as those risks
more fully discussed in the section entitled "Risk Factors" in
VistaGen's most recent Annual Report on Form 10-K for the year
ended March 31, 2020, as well as
discussions of potential risks, uncertainties, and other important
factors in either company's other filings with the Securities and
Exchange Commission. In addition, any forward-looking statements
represent the Company's views only as of today, and should not be
relied upon as representing its views as of any subsequent date.
The Company explicitly disclaims any obligation to update any
forward-looking statements.
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SOURCE VistaGen Therapeutics