Full Press Release Details
VistaGen Therapeutics Announces USPTO Grant of Patent for Treatment
of Depression with Fast-Acting PH10 Neuroactive Nasal
completed Phase 2a clinical study of PH10 demonstrated significant
antidepressant effects without psychological side effects or safety
concerns after only one week of administration Phase 2b clinical
trial for treatment of Major Depressive Disorder (MDD) planned for
SOUTH SAN FRANCISCO, Calif., July 23, 2019 - VistaGen
Therapeutics (NASDAQ: VTGN), a clinical-stage
biopharmaceutical company developing new generation medicines for
central nervous system (CNS) diseases and disorders with high unmet
need, today announced that the U.S. Patent and Trademark Office
10,322,138 related to methods of treating major depressive
disorder (MDD) with VistaGen's PH10 neuroactive nasal spray,
a potential first-in-class, neurosteroid administered in microgram
doses for treatment of MDD. The newly granted
patent will not expire until at least 2034. Counterpart foreign
patents have already been issued in China, Europe, Japan and
several other countries.
continue to assemble a strong portfolio of patents related to our
CNS drug pipeline. This newly granted patent is a key component of
our commercial protection strategy for PH10 in the U.S.,
Shawn Singh, Chief Executive Officer of VistaGen.
Based on positive results of an exploratory Phase 2a study
of PH10 as a stand-alone therapy for MDD, during which rapid-onset
antidepressant effects were observed at microgram doses, without
systemic exposure, psychological side effects or safety concerns,
we are preparing for Phase 2b clinical development of PH10 in 2020,
initially as a novel, fast-acting, at-home stand-alone treatment
affects approximately 16 million adults in the U.S. and is a common
and potentially debilitating illness that can have profound
emotional, functional and economic impact on both those who suffer
from the disorder and their loved ones. The impact of depression is
greatest for those who do not benefit from standard treatments
currently available. With both PH10 and AV-101, our novel oral NMDA
receptor antagonist currently in Phase 2 development as an add-on
treatment for MDD, our goal is to help fill the void of inadequate
current therapies for MDD and transform the treatment landscape for
individuals with MDD. Unfortunately, there is no one size
fits all' solution for depression. With their unique
mechanisms of action, we believe both AV-101 and PH10 have
potential for multiple applications in global depression markets,
as stand-alone therapies, or as add-on therapies to augment current
FDA-approved antidepressants, and to prevent relapse following
successful treatment with ketamine-based therapies,
continued Mr. Singh.
PH10 for MDD, Phase 2a Study and Next Steps:
exploratory 30-patient Phase 2a clinical study, PH10 was
well-tolerated and, at microgram doses, demonstrated rapid-onset
antidepressant effects, as measured by the Hamilton Depression
Rating Scale (HAM-D), without psychological side effects or safety
concerns. VistaGen is planning Phase 2b clinical development of
PH10 in 2020 initially as a new stand-alone treatment for MDD. With
its exceptional safety profile during clinical development to date,
PH10 also has potential to change the current paradigm for
treatment of treatment-resistant depression (TRD) with
ketamine-based therapy (intravenous ketamine or esketamine nasal
spray, both of which must be administered in a clinical setting),
by enabling those who respond to such therapy to transition to more
convenient at-home administration of PH10 to maintain the
therapeutic benefits of ketamine or esketamine.
PH10 is a novel, rapid-acting CNS neuroactive nasal spray
administered in microgram doses. PH10 activates nasal chemosensory
receptors that, in turn, engage neural circuits that lead to rapid
antidepressant effects without psychological side effects, systemic
exposure or safety concerns often associated with current
antidepressants and ketamine-based therapy (intravenous
ketamine or esketamine nasal spray). Based on positive results of an
exploratory 30-patient Phase 2a clinical study in MDD in which
rapid-onset antidepressant effects were observed without
psychological side effects or systemic exposure, VistaGen is
preparing for planned Phase 2b clinical development of PH10 in
2020, initially as a new stand-alone treatment for
About Major Depressive Disorder (MDD)
MDD is a serious neurobiologically-based mood disorder, affecting
approximately 16 million adults in the U.S., according to the NIMH.
Individuals diagnosed with MDD exhibit depressive symptoms, such as
a depressed mood or a loss of interest or pleasure in daily
activities, for more than a two-week period, as well as impaired
social, occupational, educational or other important functioning
which has a negative impact on their quality of life. Globally, MDD
affects nearly 300 million people of all ages and is the leading
cause of disability worldwide.
VistaGen Therapeutics is a clinical-stage biopharmaceutical company
developing new generation medicines for CNS diseases and disorders
with high unmet need. VistaGen's
three CNS drug candidates, AV-101, PH10 and PH94B. For more
information, please visit www.vistagen.com and
connect with VistaGen on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This release contains various statements concerning VistaGen's
future expectations, plans and prospects, including without
limitation, our expectations regarding development and
commercialization of our drug candidates, including PH10 and AV-101
for MDD, all of which constitute forward-looking statements for the
purposes of the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
neither promises nor guarantees of future performance and are
subject to a variety of risks and uncertainties, many of which are
beyond our control, and may cause actual results to differ
materially from those contemplated in these forward-looking