Research presented at the Annual Meeting of the
Society of Biological Psychiatry and of the American Society of
Clinical Psychopharmacology highlight fundamentally differentiated
mechanism of action for PH94B
These preclinical data demonstrate that
intranasal radiolabelled-PH94B is largely confined to the nasal
passages where it stimulates chemosensory neurons located in the
nasal epithelium. The localized effect within the nasal epithelium
may explain why PH94B’s anxiolytic properties in humans do not
require systemic uptake or transport into the brain.
VistaGen Therapeutics, Inc. (Nasdaq: VTGN) (VistaGen) a late
clinical-stage, central nervous system (CNS) focused
biopharmaceutical company aiming to transform the treatment
landscape for individuals living with anxiety, depression and other
CNS disorders, announced that researchers will present preclinical
data supporting the differentiated mechanism of action (MOA) for
VistaGen’s lead product candidate, PH94B, at two upcoming major
scientific congresses. VistaGen is currently evaluating PH94B in
multiple Phase 3 trials for the acute treatment of anxiety in
adults with social anxiety disorder (SAD).
Louis Monti, M.D., Ph.D., VistaGen’s Vice President of
Translational Medicine, will present the data based on the study,
Brain and Peripheral Distribution of Intranasal Radiolabeled PH94B
in Laboratory Rats as follows:
- As a late-breaking poster presentation on April 30 from 3:00
p.m. to 5:00 p.m. Pacific Time at the Annual Meeting of the Society
of Biological Psychiatry (SOBP), occurring on April 28 – April 30,
2022, in New Orleans, Louisiana; and
- As a poster at the Annual Meeting of the American Society of
Clinical Psychopharmacology (ASCP), occurring May 31 – June 03,
2022, in Scottsdale, Arizona.
Late last year, VistaGen released preclinical data that further
support that the proposed MOA of PH94B involves binding to
receptors of peripheral neurons in the nasal passages, rather than
neuronal receptors in the CNS. These data suggest that anxiolytic
activity can be achieved without systemic exposure or transport
into the brain, resulting in a lower risk for side effects.
“VistaGen is committed to transforming the existing standards of
treatments for anxiety and depression disorders,” said Shawn Singh,
Chief Executive Officer of VistaGen. “As these preclinical data
demonstrate, the proposed mechanism of action of our Phase 3
clinical candidate, PH94B, is fundamentally unique from all
currently available anti-anxiety therapies. In the pandemic years
alone, mental health crisis incidents have tripled, making it clear
that patients need options that are faster, safer, and more
tolerable than the current products on the market. Our ongoing
PALISADE Phase 3 Program for SAD is designed to assess PH94B’s
potential to address that need.”
About PH94B
VistaGen’s PH94B is a first-in-class, rapid-onset (approximately
15 minutes) pherine nasal spray being evaluated for the acute
treatment of SAD in adults. Pherines are odorless, synthetic
neuroactive steroids that bind to distinct receptors on
chemosensory cells in the nasal passages and can impact the limbic
amygdala without systemic uptake. Designed to be administered
intranasally at microgram doses, the unique potential MOA of PH94B
is fundamentally differentiated from all current anti-anxiety
medications, including benzodiazepines. PH94B’s proposed MOA does
not involve either direct activation of GABA-A receptors or binding
to neuronal receptors in the CNS. Rather, PH94B’s proposed MOA
involves binding to peripheral neurons in the nasal passages, with
very limited systemic exposure. Taken together, these data suggest
that PH94B has the potential to achieve rapid-onset anti-anxiety
effects without systemic uptake or transport into the brain,
reducing the risk of benzodiazepine-like side effects and other
safety concerns. VistaGen is currently evaluating PH94B in two
Phase 3 clinical studies in the U.S., PALISADE-1 and PALISADE-2,
and a long-term safety study, for the acute treatment of anxiety in
adults with SAD. The FDA has granted Fast Track designation for the
development of PH94B as a potential treatment for SAD.
About VistaGen
VistaGen (Nasdaq: VTGN) is a late clinical-stage, CNS-focused
biopharmaceutical company striving to transform the treatment
landscape for individuals living with anxiety, depression and other
CNS disorders. The Company is advancing therapeutics with the
potential to be faster-acting, and with fewer side effects and
safety concerns, than those that are currently available.
VistaGen’s clinical-stage candidates are targeting multiple forms
of anxiety and depression. They belong to a new class of drugs
known as pherines, which are odorless, neuroactive steroids that
bind to distinct receptors on chemosensory neurons in the nasal
passages and can impact the limbic amygdala without systemic uptake
or direct activity on CNS neurons in the brain. VistaGen’s lead
candidate, PH94B, is a nasally administered spray currently in
multiple Phase 3 trials in the U.S., with results anticipated in
2022. Should ongoing Phase 3 studies be successful, PH94B has the
potential to be the first FDA-approved, fast-acting, acute
treatment of anxiety for adults with social anxiety disorder. With
an experienced leadership team and a steady flow of near- and
long-term potential milestones, VistaGen is passionate about
transforming mental health care and redefining what is possible in
the treatment of anxiety and depression. Connect at
www.VistaGen.com.
Forward Looking Statements
This press release contains certain forward-looking statements
within the meaning of the federal securities laws. These
forward-looking statements involve known and unknown risks that are
difficult to predict and include all matters that are not
historical facts. In some cases, you can identify forward-looking
statements by the use of words such as “may,” “could,” “expect,”
“project,” “outlook,” “strategy,” “intend,” “plan,” “seek,”
“anticipate,” “believe,” “estimate,” “predict,” “potential,”
“strive,” “goal,” “continue,” “likely,” “will,” “would” and
variations of these terms and similar expressions, or the negative
of these terms or similar expressions. Such forward-looking
statements are necessarily based upon estimates and assumptions
that, while considered reasonable by VistaGen and its management,
are inherently uncertain. The Company’s actual results or
developments may differ materially from those projected or implied
in these forward-looking statements. Factors that may cause such a
difference include, without limitation, risks and uncertainties
relating to delays in launching, conducting and/or completing
ongoing and planned clinical trials, including delays due to the
impact of the ongoing COVID-19 pandemic; fluctuating costs of
materials and other resources required to conduct the Company’s
ongoing and/or planned clinical and non-clinical trials; market
conditions; the impact of general economic, industry or political
conditions in the United States or internationally; adverse
healthcare reforms and changes of laws and regulations;
manufacturing and marketing risks, which may include, but are not
limited to, unavailability of or delays in delivery of raw
materials for manufacture of the Company’s CNS drug candidates due
to the ongoing COVID-19 pandemic or otherwise; inadequate and/or
untimely supply of one or more of the Company’s CNS drug candidates
to meet demand; entry of competitive products; and other technical
and unexpected hurdles in the development, manufacture and
commercialization of the Company’s CNS drug candidates; and the
risks more fully discussed in the section entitled "Risk Factors"
in the Company’s most recent Annual Report on Form 10-K for the
fiscal year ended March 31, 2021 and in the Company’s most recent
Quarterly Report on Form 10-Q for the quarter ended December 31,
2021, as well as discussions of potential risks, uncertainties, and
other important factors in our other filings with the U.S.
Securities and Exchange Commission (SEC). The Company’s SEC filings
are available on the SEC’s website at www.sec.gov. You should not
place undue reliance on these forward-looking statements, which
apply only as of the date of this press release and should not be
relied upon as representing the Company’s views as of any
subsequent date. The Company explicitly disclaims any obligation to
update any forward-looking statements, other than as may be
required by law. If the Company does update one or more
forward-looking statements, no inference should be made that the
Company will make additional updates with respect to those or other
forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20220421005424/en/
Media Nate Hitchings SKDK nhitchings@skdknick.com
Investors Mark Flather Vice President, Investor
Relations, VistaGen Therapeutics Phone: (650) 577-3617 Email:
mflather@vistagen.com
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