Full Press Release Details
VistaGen Therapeutics Acquires Worldwide Rights to Develop and
Commercialize PH10, a First-in-Class Intranasally Administered
Neuroactive Steroid with Rapid-onset Antidepressant Effects for
Major Depressive Disorder Demonstrated in Phase 2a
PH10 demonstrated in Phase 2a study significant antidepressant
effects without psychological side effects after only one week of
South San Francisco, Calif. (October 25, 2018)
Therapeutics Inc (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 Company has exercised its option to
acquire from Pherin Pharmaceuticals, Inc. (Pherin) the exclusive
license for worldwide rights to develop and commercialize
first-in-class, intranasally administered neuroactive steroid (a
pherine ), with rapid-onset antidepressant effects for
treatment of major depressive disorder (MDD) demonstrated in a
phase 2a study. The Company secured the option for PH10
concurrently with its previously announced license agreement with
Pherin for worldwide rights to develop and commercialize
PH94B, also a first-in-class neuroactive pherine, which VistaGen is
preparing for pivotal Phase 3 development as a nasal spray for
acute on-demand treatment of social anxiety disorder
nasal chemosensory receptors that in turn engage GABA
(gamma-aminobutyric acid) and CRH (corticotropin-releasing hormone)
neurons in the limbic amygdala system. The activation of these
neural circuits is believed to have the potential to lead to a
rapid antidepressant effect.
Liebowitz, M.D., a member of VistaGen's CNS Clinical and
Regulatory Advisory Board, has acted as an advisor to Pherin in
connection with its clinical trials of PH10 and PH94B and
previously presented results for PH10's eight-week,
double-blind, single-center, 30-patient, Phase 2a study for MDD.
Results in the Phase 2a study demonstrated that self-administered
doses of PH10 as a nasal spray resulted in significant decreases in
depression as measured by the Hamilton Rating Scale for Depression,
a widely used clinician-administered depression assessment scale.
In this study, PH10 was very well tolerated with minimal side
After extensive due diligence and guidance from Dr.
Liebowitz, we exercised our option to acquire exclusive rights to
develop and commercialize PH10 for depression and other CNS
diseases, said Shawn Singh, Chief
Executive Officer of VistaGen. Depression is a
complicated disease, without a one-size-fits-all solution.
Development of promising treatment alternatives with fundamentally
different mechanisms of action from current antidepressants is a
core competency of our team. We are excited to build upon the
notable and steadfast efforts of Dr. Louis Monti, Dr. Liebowitz and
Pherin's entire team in developing PH10 to date. PH10 marks
yet another valuable asset in our growing pipeline, with compelling
data and complementary to our core focus on developing innovative
rapid-onset treatments for MDD beyond ketamine with convenient
administration and without debilitating or psychological side
effects and safety concerns. We
believe that having yet another potentially safe, fast-acting, new
generation mechanism of action treatment in play, in addition to
AV-101 with its NMDAR GlyB and AMPAR targets, adds strength to
strength, allowing us to provide patients with an even broader
range of potential solutions to treat MDD, and expands our
potential opportunities to monetize our assets to the benefit of
Depression is a pervasive mental illness and currently
available treatments fall short for many individuals with the
disease. Ultra-low doses of intranasal PH10, with its novel
mechanism of action, rapid onset activity and excellent safety and
tolerability profile demonstrated in a phase 2a study, may
represent another life-changing opportunity to address the growing
unmet need among individuals suffering from MDD, stated Dr.
Pherines inhibit nerve circuits mediating behavioral and
physiological effects of anxiety. This mechanism of action, rapid
onset of efficacy and excellent safety and tolerability profile
have been shown in multiple previous clinical trials, including a
pilot Phase 3 feasibility study evaluating the safety and efficacy
of PH94B for SAD and Phase 2 feasibility study evaluating the
safety and efficacy of PH10 for MDD.
In connection with the consummation of the license and option
agreements, VistaGen issued to Pherin $2.0 million of its
unregistered common stock (925,926 unregistered
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing new generation medicines for multiple CNS diseases and
disorders with high unmet need. For more information, please visit
and connect with VistaGen on Twitter,
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 AV-101 for MDD,
neuropathic pain and suicidal ideation, PH94B for SAD, and PH10 for
MDD, as well as our intellectual property and commercial protection
of our drug candidates, 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 statements. Among these risks is the
possibility that (i) we may encounter unexpected adverse events in
patients in our clinical development of any product candidate that
cause us to discontinue further development, (ii) we may not be
able to successfully demonstrate the safety and efficacy of our
product candidates at each stage of clinical development, (iii)