Full Press Release Details
VistaGen Therapeutics Reports Fiscal 2021 Second Quarter Financial
Results and Provides Highlights on its CNS Pipeline and Business
Positive FDA Meeting Sets Key Pathway for Pivotal PH94B Phase 3
Study in the Second Quarter of 2021
Received Over $17.5 Million Net Proceeds from PH94B Upfront License
Payment and Public Offering of Common Stock
Positive New Data from Second Preclinical Study of AV-101 in
Combination with Probenecid
Positive Preclinical Data Differentiating Mechanism of Action of
PH94B from Risk-Ridden Benzodiazepines
SOUTH SAN FRANCISCO, Calif., November 12, 2020 VistaGen
Therapeutics (NASDAQ: VTGN), a
biopharmaceutical company developing new generation medicines for
anxiety, depression and other central nervous system (CNS)
disorders, today reported its financial results for the fiscal 2021
second quarter ended September 30, 2020 and provided an update on
its CNS pipeline and business progress.
"We see a significant rise
in mental health concerns as the global COVID-19 pandemic continues
to impact the daily lives of millions of individuals. We are
committed to developing innovative therapies that provide relief to
those suffering from anxiety and depression, and we are working
diligently towards that goal. We are making significant progress in
preparing PH94B for launch of a pivotal Phase 3 study for acute
treatment of anxiety in adults with social anxiety disorder in the
second quarter of 2021. After reaching consensus with the FDA on
the key components of the study design, it will be very similar to
the statistically significant Phase 2 study of PH94B in social
anxiety disorder. We are also working with the FDA to
finalize details for our Phase 2A study of PH94B
in adjustment disorder, which we are planning to initiate in early
2021, said Shawn Singh, Chief
Executive Officer of VistaGen.
Millions of people rely on benzodiazepines and other
prescription drugs to manage symptoms of stress and anxiety. While
some medications are safe and effective treatments, many in the
current treatment paradigm have limited therapeutic benefits and
potentially serious side effects and safety concerns. In
Phase 2 clinical studies, PH94B produced rapid
onset anti-anxiety effects without requiring systemic uptake and
distribution. With its rapid-onset pharmacology, lack of systemic
exposure and sedation, and its excellent safety profile in all
studies to date, we believe PH94B has the potential to displace
benzodiazepines in the drug treatment paradigm for anxiety
disorders. In addition to social anxiety disorder, we believe PH94B
also has potential as a novel treatment for adjustment disorder,
postpartum anxiety, post-traumatic stress disorder, preprocedural
anxiety, panic, and other anxiety-related disorders, and we look
forward to assessing its potential in various controlled Phase 2
clinical studies in parallel with our Phase 3 program to assess its
potential as an acute treatment of anxiety in adults with social
anxiety disorder, concluded Mr. Singh.
CNS Pipeline Highlights and Updates:
VistaGen reached consensus with the FDA on key study design and
execution aspects of the Company's initial pivotal Phase 3 study of
PH94B for acute treatment of anxiety in adults with social anxiety
As in the statistically significant (p=0.002) Phase 2 public
speaking study of PH94B in SAD, VistaGen's Phase 3 study will
involve a laboratory-simulated anxiety-provoking public speaking
The Phase 3 study will be a randomized, double-blind,
placebo-controlled, parallel comparison study conducted at
approximately 15 sites in North America.
The Subjective Units of Distress Scale (SUDS) will be used to
assess the primary efficacy endpoint in the study.
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 (completed subjects) will be approximately 182
Study expected to initiate recruitment in 2Q 2021.
VistaGen is currently preparing for an exploratory Phase 2A
clinical study of PH94B for acute treatment of adjustment disorder
(AjD), an emotional or behavioral reaction considered excessive or
out of proportion to a stressful event or significant life change,
occurring within three months of the stressor, and/or significantly
impairing a person's social, occupational and/or other
important areas of functioning. Given the diverse impact of the
COVID-19 pandemic, including, among other things, fear and anxiety
about health and safety, economic loss, unemployment, social
isolation, disruption of established education and work practices,
VistaGen submitted its preliminary protocol for the study to the
FDA through the FDA's Coronavirus Treatment Acceleration
Program (CTAP). Following that submission, the Company has
continued its discussions with the FDA's Division of
Psychiatric Products to determine the study's appropriate next
steps, including the final study protocol.
The Company is planning to conduct the proposed Phase 2A study in
New York City and enroll approximately 25 to 30 subjects suffering
from adjustment disorder-provoking stressors, including, but not
limited to, stressors related to the diverse impact of the COVID-19
pandemic and recent civil unrest in the U.S.
The AjD study is expected to initiate patient recruitment in 1Q
The Company is also planning for additional exploratory Phase 2A
studies in postpartum anxiety, post-traumatic stress disorder, and
pre-procedural anxiety (pre-MRI).
vitro electrophysiology data
demonstrating that the mechanism of action of PH94B, does not
involve direct activation of GABA-A receptors, in distinct contrast
to the mechanism of action of benzodiazepines, which act as direct
positive modulators of GABA-A receptors.