Vistagen (Nasdaq: VTGN), a clinical-stage company focused on advancing neuroscience through nose-to-brain neurocircuitry, has announced that the first participant has been enrolled in a repeat dose study of fasedienol. This investigational neuroactive pherine nasal spray is currently in Phase 3 development aimed at providing acute treatment for social anxiety disorder (SAD).
The repeat dose study is a small exploratory Phase 2 clinical trial conducted in multiple centers across the U.S. It is randomized, double-blind, and placebo-controlled, aiming to evaluate the efficacy, safety, and tolerability of administering a repeat dose of fasedienol (3.2 micrograms) to adults suffering from Social Anxiety Disorder (SAD) during a public speaking task in a clinical environment. Participants will be assigned to one of three dosing groups: one receiving fasedienol followed by another fasedienol (totaling 6.4 micrograms), another receiving fasedienol followed by a placebo (totaling 3.2 micrograms), and a third group receiving two placebos. The second dose for each group will be given ten minutes after the first. Aside from the repeat dose and the additional treatment arm, this study shares a similar design with the ongoing PALISADE Phase 3 trials, which focus on the acute treatment of adults with SAD, including an open-label extension component.
“The launch of this fasedienol repeat dose study represents a crucial advancement in our U.S. Phase 3 program aimed at treating acute social anxiety disorder,” stated Shawn Singh, President and CEO of Vistagen. “As the incidence of social anxiety disorder has risen over the years, countless individuals in the U.S. endure overwhelming fear and anxiety in daily social interactions, lacking any FDA-approved treatment for acute episodes. Our goal, along with the PALISADE Phase 3 program for fasedienol, is to transform this situation.”
Overview of Vistagen's PALISADE Phase 3 Program in the U.S. for Fasedienol in the Acute Management of Social Anxiety Disorder
Building on the statistically significant results from its PALISADE-2 U.S. Phase 3 trial of fasedienol for the acute treatment of adults with Social Anxiety Disorder (SAD) reported in 2023, Vistagen's U.S. registration-focused PALISADE Phase 3 program for fasedienol includes ongoing PALISADE-3 and PALISADE-4 U.S. Phase 3 trials, as well as a small Phase 2 repeat dose study in the U.S. Both PALISADE-3 and PALISADE-4 are multi-center, randomized, double-blind, placebo-controlled trials, designed similarly to PALISADE-2, aiming to assess the efficacy, safety, and tolerability of fasedienol for alleviating anxiety symptoms triggered by a public speaking challenge in a clinical environment. Vistagen is optimistic that either PALISADE-3 or PALISADE-4, if successful, along with the findings from PALISADE-2, could provide strong evidence supporting a New Drug Application (NDA) submission to the U.S. FDA for fasedienol's acute treatment of SAD.
Fasedienol Nasal Spray: An Overview for Treating Acute Social Anxiety Disorder Fasedienol nasal spray is a novel therapeutic option designed for the rapid management of social anxiety disorder (SAD). This innovative formulation aims to provide quick relief from the intense feelings of anxiety and fear that characterize social interactions for individuals suffering from this condition. By delivering the medication directly through the nasal mucosa, Fasedienol offers a fast onset of action, allowing users to effectively manage their symptoms during critical social situations. Ongoing research and clinical trials are assessing its efficacy and safety, with promising results indicating its potential as a valuable tool in the treatment arsenal for those struggling with social anxiety.
Fasedienol is an innovative investigational nasal spray targeting neurocircuitry, aimed at providing rapid relief with a unique mechanism of action (MOA) that sets it apart from existing anxiety treatments. This first-in-class pherine formulation is intended to modulate the olfactory-amygdala pathways associated with fear and anxiety, while minimizing the activation of the sympathetic autonomic nervous system, all without systemic absorption, enhancing GABA-A receptor activity, or interacting with brain neurons. Vistagen's PALISADE Phase 3 program is focused on securing U.S. registration for fasedienol as an acute treatment for Social Anxiety Disorder (SAD). Currently, there are no FDA-approved options for acute SAD treatment in the U.S., and fasedienol has received Fast Track designation from the FDA to expedite its development for this purpose.
Vistagen is a biopharmaceutical company focused on developing innovative therapies for mental health disorders. Its primary goal is to address the unmet needs of patients suffering from conditions such as anxiety and depression. The company leverages its proprietary drug development platform to create novel treatments that aim to improve the quality of life for individuals facing these challenges. With a commitment to advancing mental health care, Vistagen continues to explore new avenues for effective and safe therapeutic options.
Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of a new class of intranasal product candidates called pherines. Each pherine product candidate in Vistagen’s neuroscience pipeline is designed to rapidly activate brain neurocircuitry through the olfactory system to achieve desired therapeutic benefits. Pherines do not require systemic absorption or binding to neurons in the brain, which may contribute to a favorable safety profile. Vistagen’s neuroscience pipeline also includes an oral prodrug, AV-101, with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at www.Vistagen.com.
Projections and Expectations for the Future
This press release contains certain forward-looking statements within the meaning of the U.S. 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. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization, and actual timelines, results or developments may differ materially from those projected or implied in these forward-looking statements. Among other things, there can be no guarantee that any of Vistagen’s product candidates will successfully complete ongoing or future clinical trials within the timeframe estimated by Vistagen or at all, receive regulatory approval or be commercially successful, or that Vistagen will be able to successfully replicate the result of past studies of its product candidate fasedienol or its other product candidates. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to conducting and/or completing ongoing clinical trials, including trials that are a part of Vistagen’s PALISADE Phase 3 development program for fasedienol; Vistagen’s submission of a NDA to the U.S. FDA for any product candidate, including fasedienol; the ability of any clinical trial information submitted by Vistagen to the U.S. FDA to support a NDA; the availability as well as the scope and enforceability of Vistagen’s patents in the U.S. and elsewhere, including patents related to Vistagen’s pherine product candidates and AV-101; fluctuating costs of materials and other resources and services required to conduct Vistagen’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; and other technical and unexpected hurdles in the development, manufacture and commercialization of Vistagen’s product candidates. These risks are more fully discussed in the section entitled “Risk Factors” in Vistagen’s most recent Annual Report on Form 10-K for the fiscal year ended March 31, 2024, and Quarterly Report on Form 10-Q for the period ended September 30, 2024, 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). Vistagen’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 Vistagen’s views as of any subsequent date. Vistagen explicitly disclaims any obligation to update any forward-looking statements other than as may be required by law. If Vistagen does update one or more forward-looking statements, no inference should be made that Vistagen will make additional updates with respect to those or other forward-looking statements.
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Vistagen Therapeutics
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Vistagen Therapeutics
KEY PHRASE: CALIFORNIA, USA, NORTH AMERICA
INDUSTRY KEYWORDS: BIOTECHNOLOGY, MENTAL WELLNESS, HEALTHCARE, PHARMACEUTICALS, CLINICAL STUDIES
ORIGIN: Vistagen
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发布：2025年1月10日 上午8:30 / 讨论：2025年1月10日 上午8:30
