- Company
signs a worldwide licensing agreement with Pherin Pharmaceuticals for the
development and commercialization of a Phase 3-ready CNS drug candidate
for as-needed treatment of social anxiety disorder
- Untreated
social anxiety disorder has a significant impact on a person’s overall
quality of life
- Clinical
studies support the potential of PH94B to be a superior treatment
alternative for SAD due to the demonstrated rapid onset of efficacy, route
of administration, as-needed dosing convenience and excellent safety
profile
VistaGen Therapeutics, Inc. (NASDAQ: VTGN) is a
clinical-stage biopharmaceutical company developing new generation medicines
for depression and other central nervous system (CNS) diseases and disorders
with high unmet need. The company recently announced (http://ibn.fm/d4viI) that it has
signed a license with Pherin Pharmaceuticals, Inc., a biopharmaceutical company
focused on developing novel treatments for neuropsychiatric and neuroendocrine
conditions, for exclusive worldwide rights of a Phase 3-ready CNS drug
candidate for as-needed treatment of social anxiety disorder.
An estimated 15 million American adults are affected by
social anxiety disorder, also called social phobia or SAD. It is the third most
common psychiatric condition, following depression and substance use, and
generally precedes other disorders. A person suffering from SAD may have
unrealistic fears of one or more social or performance situations that may have
a significant impact on the person’s employment, social activities and overall
quality of life.
Antidepressants are a common treatment for SAD but have a
slow onset that may take several weeks to work, have numerous side effects and
must be taken consistently over a long period of time. At this time, there is
no FDA-approved treatment that provides rapid relief.
VistaGen has acquired exclusive worldwide rights from Pherin
to develop and commercialize PH94B nasal spray, a Phase 3-ready drug candidate
for as-needed treatment of social anxiety disorder, to address this problem. In
a news release, Shawn Singh, CEO of VTGN, stated, “We are excited to be
working with Pherin’s innovative team to develop and commercialize this
medically and socially impactful treatment. Our key objective for the PH94B
program is to commence our initial pivotal Phase 3 clinical trial of PH94B
nasal spray for SAD during the first half of 2019.”
The PH94B nasal spray utilizes Pherin’s first-in-class
proprietary compounds called pherines. These synthetic neuroactive steroids
engage chemosensory receptors inhibiting nerve circuits, mediating behavioral
and physiological effects of anxiety. By engaging receptors in the nasal
passage, pherines are rapidly effective in low quantities. The onset of results
provides an excellent safety profile with greater patient convenience. Previous
clinical trials of PH94B provided evidence of rapid (10-15 minutes) anxiety reduction
of subjects with SAD and no adverse events with the nasal spray administration.
“This agreement provides a meaningful opportunity to
continue our clinical progress and advance our mission to bring novel treatment
alternatives to the many individuals affected with SAD,” added Dr. Louis Monti,
executive vice president of Pherin, “Our prior clinical studies support the
potential of PH94B to be a superior treatment alternative for SAD due to the
demonstrated rapid onset of efficacy, route of administration, as-needed dosing
convenience, and excellent safety profile compared to other existing
therapeutic options which require chronic dosing and have concurrent side
effects.”
VistaGen has also acquired an option from Pherin to license
an additional CNS neuropsychiatry-focused product now in Phase 2 development.
For more information, visit the company’s website at www.VistaGen.com
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