Full Press Release Details
Positive Pilot Phase 3 Data Position VistaGen's PH94B
Neuroactive Nasal Spray for Pivotal
Phase 3 Development as a Novel, As-Needed Treatment for
Social Anxiety Disorder
PH94B has potential to be the First FDA-Approved PRN Treatment for
Social Anxiety Disorder
New Findings Presented at the 2019 Anxiety and Depression
Association of America Annual Conference
SOUTH SAN FRANCISCO, CA April 1, 2019
Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
depression, social anxiety disorder and other central nervous
system (CNS) diseases and disorders with high unmet need, announced
today additional results from a positive pilot Phase 3 study of
first-in-class neuroactive nasal spray shown to be effective on an as-needed
(PRN) basis for treatment of social anxiety disorder (SAD).
The new data were presented in a poster session at the 2019 Anxiety and
Depression Association of America (ADAA) Annual Conference
22-patient, four-week, randomized, double blind, placebo-controlled
pilot Phase 3 crossover study, subjects receiving PH94B had a
significantly greater decrease in average peak Subjective Units of
Distress scores compared to placebo within one week of
treatment.1 There was also a
significantly greater decrease in Liebowitz Social Anxiety Scale
(LSAS) avoidance scores for subjects who received PH94B first,
before crossing over to placebo. Administered at microgram doses
and consistent with results from prior Phase 2 studies,
PH94B's safety profile was excellent, with no serious adverse
currently preparing for pivotal Phase 3 development of PH94B as a
novel first-line PRN treatment for SAD, with Dr. Michael Liebowitz,
developer of the LSAS, a widely-used primary outcome measure in SAD
for both clinical research and for evaluation in clinical practice,
acting as Principal Investigator for the study.
Social anxiety disorder is one of the most prevalent mental
health conditions in the U.S., affecting as many as 15 million
Americans. In both Phase 2 and pilot Phase 3 clinical studies,
PH94B was more effective than placebo in the whole sample on the
primary outcome measure. In the Phase 2 trial, which included both
a public speaking and a social situation challenge, PH94B
significantly improved the primary efficacy endpoint within 10 to
15 minutes of self-administration. These positive results
demonstrate PH94B's potential to change the lives of millions
of people suffering from SAD, said Dr. Liebowitz, Principal
Investigator of the pilot Phase 3 study. I support
VistaGen's plans for a pivotal Phase 3 program launch in
2020. PH94B neuroactive nasal spray has potential to be the first
FDA-approved PRN treatment for SAD.
Current treatments for SAD fall far short of patient
needs, stated Mark Smith, MD, PhD, VistaGen's Chief
Medical Officer. With its unique mechanism of action,
exceptional safety profile and rapid-onset activity, we are excited
about PH94B's potential to transform the current treatment
paradigm for SAD. We look forward to working closely with the FDA
and Dr. Liebowitz as we prepare for and execute pivotal Phase 3
development of PH94B for SAD.
About PH94B Neuroactive Nasal Spray
neuroactive nasal spray is fundamentally different from all current
treatments for SAD. Developed from proprietary compounds called
pherines and administered as a nasal spray, PH94B activates nasal
chemosensory receptors that trigger neural circuits in the brain
that suppress fear and anxiety. Its novel mechanism of
pharmacological action, rapid-onset of therapeutic effects and
exceptional safety and tolerability profile shown in clinical
trials to date make PH94B neuroactive nasal spray an excellent
product candidate with potential to become the first FDA-approved
PRN treatment for SAD.
published double-blind, placebo-controlled Phase 2 clinical trial,
PH94B neuroactive nasal spray was significantly more effective than
placebo in reducing public-speaking and social interaction anxiety
on laboratory challenges of individuals with SAD.2.
About Social Anxiety Disorder
affects as many as 15 million Americans and is the third most
common psychiatric condition after depression and substance use.
SAD is characterized by a persistent and unreasonable fear of one
or more social or performance situations, where the individual
fears that he or she will act in a way or show symptoms that will
be embarrassing or humiliating, leading to avoidance of the
situations when possible and anxiety or distress when they occur.
These fears have a significant impact on the person's
employment, social activities and overall quality of life. SAD is
commonly treated chronically with antidepressants, which have a
slow onset of effect (several weeks) and known side effects that
may make them unattractive to individuals affected by
Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for multiple CNS diseases and
disorders with high unmet need. VistaGen's CNS pipeline
includes three drug candidates (AV-101, PH10, and PH94B) with
potential for at-home use, rapid-onset therapeutic benefits and
exceptional safety. Each CNS drug candidate in VistaGen's pipeline
is either currently in or has completed Phase 2 clinical
development. AV-101, an oral NMDA receptor glycine site antagonist
(a full antagonist), is in Phase 2 development in the U.S. for
major depressive disorder (MDD) and in a first-step target
engagement study in healthy volunteer U.S. military Veterans for
suicidal ideation. The FDA has granted Fast Track designation for
development of AV-101, both as a potential adjunctive treatment
for MDD and as a non-opioid treatment
for neuropathic pain. PH10 is a potential first-in-class
neuroactive nasal spray with rapid-onset antidepressant effects
observed at microgram doses and without systemic exposure. PH10 is