VistaGen cooperates with Aimu Medical to complete the global Phase III clinical trial application of PH94B PALISADE

VistaGen Therapeutics, Inc.
(Nasdaq: VTGN) (VistaGen) and AffaMed Therapeutics today announced that the parties have completed preparations to initiate a global Phase 3 clinical trial of PALISADE in the United States and China to To evaluate the efficacy, safety, and tolerability of PH94B (Aimu Medical AM005) when acutely administered in the treatment of adult patients with social anxiety disorder (SAD)
.
The study design is based on VistaGen's ongoing US Phase 3 study of PH94B PALISADE-1 and PALISADE-2
.
The primary purpose of the PALISADE global study is to support the potential commercialization of PH94B in China and other markets outside the United States
.
VistaGen recently submitted a global study proposal for PALISADE to the U.
S.
Food and Drug Administration (FDA) based on an existing Investigational New Drug (IND) application for PH94B for SAD; Regulatory clearance for its Clinical Trial Application (CTA)
.
Together, the clinical licenses in China and the U.
S.
set the stage for the launch of the PALISADE global study in the U.
S.
and China in the second half of 2022
.
In addition to this, the companies plan to initiate the Phase 3 study in Canada, Mexico and South Korea
.
As an odorless, fast-acting pheromone nasal spray, PH94B has a unique potential mechanism of action for acute administration of anxiety in adult SAD patients
.
In terms of mode of action, PH94B is different from the current FDA or NMPA approved therapies for the treatment of SAD
.
"We are very pleased with the significant progress the team has made to initiate the PALISADE global study in two of the world's largest pharmaceutical markets
.
Shawn Singh, CEO of VistaGen, said, "The successful approval of AMU by the NMPA reinforces our belief in AMU as the best partner for PH94B in China
.
" We are confident in our collaboration as we continue to advance the important late-stage clinical program of PH94B for acute administration of anxiety in adults with SAD
.
VistaGen will continue to work tirelessly to bring transformative mental health treatments to millions of people around the world who need better, safer and faster-acting treatments for anxiety disorders
.
"The approval of PALISADE's global Phase 3 clinical trial by the China Food and Drug Administration is another major milestone in our progress in advancing our product portfolio in neurological and psychiatric diseases," said
Dr.
The number of SAD patients in China, Korea and Southeast Asia continues to grow, and I am proud of the team's focus on delivering innovative treatment options to patients and the results they have achieved
.
We would like to thank VistaGen for its important contribution to the submission of the PH94B IND application to the US FDA, and also to the NMPA for acknowledging the importance of this Phase 3 study and for expediting the approval of the associated CTA
.
We look forward to subject dosing later this year
.
In June 2020, Aimu Medical entered into a strategic license and collaboration agreement with VistaGen Therapeutics to acquire the rights to clinically develop and commercialize PH94B in China, South Korea and Southeast Asia
.
As of now, the pharmaceutical regulatory authorities in the United States and China have not approved any Medications used acutely (as needed) to treat anxiety in adults with SAD
.
In the U.
S.
, SAD is typically treated with certain FDA-approved antidepressants that are slow-acting (takes several weeks) and benefit from treatment Limited
.
Benzodiazepines are not FDA-approved for the treatment of SAD and are off-label use
.
Both antidepressants and benzodiazepines have known side effects and safety concerns that may discourage many people with SAD from taking them
.
About the PALISADE Global Study The PALISADE Global Study is a randomized, multi-regional, multi-center, double-blind, placebo-controlled Phase 3 clinical trial based on VistaGen's ongoing Phase 3 clinical trials of PALISADE-1 and PALISADE-2 in the United States
.
The PALISADE Global Research Clinical Center covers the United States, China, Canada, Mexico and South Korea and plans to enroll approximately 208 adult subjects
.
Dr.
Michael Liebowitz, a Columbia University psychiatrist, former director and founder of the Center for Anxiety Disorders at the New York State Institute of Psychiatry, director of the New York City Medical Research Network, and inventor of the Liebowitz Social Anxiety Scale (LSAS), served 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 published Phase 2 study of PH94B in adults with SAD administered acutely
.
The Phase 2 study found that PH94B rapidly reduced anxiety (within 15 minutes) in public speaking situations (p=0.
002)
.
VistaGen plans to begin enrolling PALISADE global study subjects in the second half of 2022, with key clinical results expected in mid-2024
.
Two studies, PALISADE-1 and PALISADE-2, are currently underway and the results will be used to support VistaGen's submission of a New Drug Application (NDA) for PH94B to the FDA
.
The PALISADE global study is independent of the above two studies and is primarily intended to support regulatory submissions in China and other markets outside the United States
.
About PH94B (Aimu Medical AM005) PH94B is a first-in-class pheromone nasal spray with rapid onset of action (approximately 10-15 minutes) and is currently undergoing clinical evaluation for the treatment of SAD in adults
.
Pheromones are odorless synthetic neuroactive steroids administered intranasally in microgram doses that bind to receptors on chemosensory cells in the nasal cavity and can affect the limbic amygdala without systemic absorption
.
Its unique mechanism of action is completely different from all current anti-anxiety drugs, including benzodiazepines, and does not involve direct activation of GABA-A receptors or binding to central nervous system neuronal receptors, thereby minimizing Potential systemic exposure, suggesting that PH94B can achieve rapid anxiolytic effects without requiring systemic uptake or causing the side effects and safety concerns of benzodiazepines
.
Currently, PH94B has not been approved by the FDA, NMPA or any other regulatory agency for use in patients outside of clinical studies
.
In addition to the PALISADE global study, VistaGen is evaluating the long-term safety of PH94B in a Phase 3 clinical study, with results used to support VistaGen's NDA submission to the FDA
.
The FDA has granted PH94B Fast Track for the development of a potential treatment for SAD
.
About Social Anxiety Disorder (SAD) Worldwide, 188 million people are affected by social anxiety disorder, with 23.
7 million in the United States and at least 11.
3 million in China
.
1,2,3 According to the National Institutes of Health, SAD is the third most common mental disorder in the United States after depression and substance abuse
.
SAD can interfere with work, school, and other daily activities
.
Currently, neither the FDA nor the NMPA have approved any fast-acting drugs for acute administration of SAD
.
References: 1.
Kantar Health.
September 2020.
National Health and Wellness Survey (NHWS), 2020.
[US].
Malvern, PA.
2.
Stein, DJ, Lim, CCW, Roest, AM 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.