Companies plan to initiate the global study of PH94B for the
acute treatment of social anxiety disorder (SAD) in the second half
of 2022
Trial designed to support commercialization of PH94B in China
and other markets outside the U.S.
VistaGen Therapeutics, Inc. (Nasdaq: VTGN) (VistaGen) and
AffaMed Therapeutics (AffaMed) today announced they have completed
regulatory preparations to initiate PALISADE Global, a Phase 3
clinical trial to evaluate the efficacy, safety, and tolerability
of VistaGen’s PH94B (referred to by AffaMed as AM005) for the acute
treatment of anxiety in adults with social anxiety disorder (SAD),
in the U.S. and China. The primary purpose of PALISADE Global, the
design of which is based on VistaGen’s ongoing PALISADE-1 and
PALISADE-2 Phase 3 clinical studies of PH94B in the U.S., is to
support potential commercialization of PH94B in China and other
markets outside of the U.S.
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VistaGen’s recent submission of the PALISADE Global study
protocol to the U.S. Food and Drug Administration (FDA) under its
existing PH94B Investigational New Drug (IND) application in SAD
and AffaMed’s recent receipt of regulatory clearance of its
Clinical Trial Application (CTA) from the National Medical Products
Administration (NMPA) in China have cleared the way for initiation
of PALISADE Global in the U.S. and China during the second half of
2022. The companies also anticipate initiating this Phase 3 study
in Canada, Mexico, and South Korea. PH94B is an odorless,
fast-acting neuroactive pherine nasal spray with a unique potential
mechanism of action (MOA) for the acute treatment of anxiety in
adults with SAD. PH94B works differently than all therapies
currently approved for the treatment of SAD by either the FDA or
the NMPA.
“We are very pleased with the substantial progress that our
teams have made toward initiating PALISADE Global in two of the
world’s largest pharmaceutical markets,” said Shawn Singh, Chief
Executive Officer of VistaGen. “AffaMed’s clearance from the NMPA
affirms our belief that AffaMed is the right partner for PH94B in
China, and we remain confident in our collaboration as we advance
this important late-stage clinical program for PH94B for the acute
treatment of anxiety in adults with SAD. VistaGen remains committed
to transforming the treatment of anxiety disorders for the millions
of individuals worldwide who need better, safer, and faster-acting
therapeutics in their journey toward mental health wellness.”
“NMPA’s clearance to begin the PALISADE Global Phase 3 trial is
a tremendous milestone in advancing our product portfolio targeting
neurological and psychiatric indications. I’m very proud of the
dedication of our teams to bring forward a new treatment option for
the rapidly growing number of individuals in China, South Korea,
and Southeast Asia living with SAD,” said Dr. Dayao Zhao, Chief
Executive Officer of AffaMed. “We appreciate VistaGen’s essential
work in the U.S. under its PH94B IND application with the FDA. We
thank the NMPA for recognizing the importance of this Phase 3 study
and rapidly expediting the approval of our CTA. We look forward to
dosing participants later this year.”
In June 2020, VistaGen Therapeutics entered into a strategic
licensing and collaboration agreement with AffaMed Therapeutics for
the clinical development and commercialization of PH94B in China,
South Korea, and Southeast Asia.
To date, health authorities in the U.S. and China have not
approved any medications for acute (as-needed) treatment of anxiety
in adults with SAD. SAD is commonly treated in the U.S. with
certain antidepressants approved by the FDA, which have a slow
onset (several weeks) and limited therapeutic benefits.
Benzodiazepines, which are not FDA-approved for the treatment of
SAD, are prescribed for off-label use. Both antidepressants and
benzodiazepines have known side effects and safety concerns that
may make them unattractive to many individuals affected by SAD.
About PALISADE Global PALISADE Global is a randomized,
multi-regional, multi-center, double-blind, placebo-controlled
Phase 3 clinical trial that replicates VistaGen’s clinical trial
design for its PALISADE-1 and PALISADE-2 Phase 3 studies of PH94B
currently underway in the U.S. PALISADE Global will encompass
clinical sites in the U.S., China, Canada, Mexico, and South Korea
with a target enrollment totaling approximately 208 randomized
adult subjects. Michael Liebowitz, M.D., a Columbia University
psychiatrist, former director and founder of the Anxiety Disorders
Clinic at the New York State Psychiatric Institute, director of the
Medical Research Network in New York City, and creator of the
Liebowitz Social Anxiety Scale (LSAS), is serving as the clinical
trial’s principal investigator.
The design of the PALISADE-1, PALISADE-2 and PALISADE Global
Phase 3 studies is substantially similar to the public speaking
component of a peer-reviewed published Phase 2 study of PH94B for
the acute treatment of anxiety in adults with SAD. In that Phase 2
study, PH94B was observed to rapidly reduce anxiety (within 15
minutes) in response to a public speaking challenge (p=0.002).
VistaGen and AffaMed plan to begin enrolling participants in
PALISADE Global during the second half of 2022, with topline
results anticipated in mid-2024. PALISADE Global is a study
separate from PALISADE-1 and PALISADE-2, which are currently
underway and designed to support VistaGen’s PH94B New Drug
Application (NDA) submission to the FDA, should the studies be
successful. The PALISADE Global trial, if successful, is primarily
intended to support regulatory submissions for potential approval
in China and certain other markets outside of the U.S.
About PH94B (AffaMed AM005) VistaGen’s PH94B is a
first-in-class, rapid-onset (approximately 15 minutes) pherine
nasal spray being evaluated for the 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 mechanism of action (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 central nervous system (CNS). Rather, PH94B’s
proposed MOA involves binding to peripheral neurons in the nasal
passages, thereby limiting the transport of molecules to the
circulatory system and minimizing systemic exposure, suggesting
that PH94B has the potential to achieve rapid-onset anti-anxiety
effects without requiring systemic uptake or causing
benzodiazepine-like side effects and safety concerns. Currently,
PH94B is not approved by the FDA, the NMPA, or any other regulatory
agency for use in patients outside clinical studies. Separate from
PALISADE Global, VistaGen is currently evaluating PH94B in Phase 3
clinical studies and a long-term safety study that, if successful,
will support VistaGen’s PH94B NDA submission to the FDA. The FDA
has granted Fast Track designation for the development of PH94B as
a potential treatment for SAD.
About Social Anxiety Disorder (SAD) Social anxiety
disorder affects as many as 23.7 million Americans and 188 million
worldwide, including at least 11.3 million in China.1,2,3 According
to the National Institutes of Health, SAD is the third most common
psychiatric condition after depression and substance use in the
United States. SAD can interfere with going to work, attending
school, and a wide variety of common, everyday social and
performance situations. Currently, there are no rapid-onset
medications approved by the FDA or NMPA for the acute treatment of
SAD.
About VistaGen VistaGen (Nasdaq: VTGN) is a late
clinical-stage, neuro-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 lead 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 asset, 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.
About AffaMed AffaMed Therapeutics is a clinical stage
biopharmaceutical company focused on developing and commercializing
transformative pharmaceutical, digital and surgical products that
address critical unmet medical needs in ophthalmological,
neurological and psychiatric disorders for patients in Greater
China and around the world. The leadership team at AffaMed
Therapeutics has gained deep industry expertise and an extensive
track record in high-quality discovery, clinical development,
regulatory affairs, business development, manufacturing, and
commercial operations at leading multi-national biopharmaceutical
companies in China and globally. To conform with product portfolio
naming convention, AffaMed refers to PH94B as AM005 in its
materials.
1. Kantar Health. September 2020. National Health and Wellness
Survey (NHWS), 2020. [US]. Malvern, PA.
2. Stein, D.J., Lim, C.C.W., Roest, A.M. et al. The
cross-national epidemiology of social anxiety disorder: Data from
the World Mental Health Survey Initiative. BMC Med 15, 143
(2017).
3. Frost & Sullivan. January 2022. Global Market Study of
CNS and Opthalmic Treatment Market, 2022. Shanghai, China.
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, its management and VistaGen’s partners, 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, both in the U.S. and internationally, 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 U.S. or
internationally; adverse healthcare reforms and changes of any
applicable 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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Media For VistaGen Chantal Allan Sam Brown Inc.
chantalallan@sambrown.com (805) 242-3080
For AffaMed Glacier Qin Associate Director, Public Relations
Glacier.qin@affamed.com +86 (21) 5250 8611
Investors For VistaGen Mark Flather Vice President,
Investor Relations, VistaGen Therapeutics Phone: (650) 577-3617
Email: mflather@vistagen.com
For AffaMed Dominic Chu Associate Director, Corporate Finance
Dominic.chu@affamed.com +852 2912 9004
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