VistaGen Therapeutics Further Advances PALISADE Phase 3 Program for PH94B in Social Anxiety Disorder with Initiation of PALISADE-2
PALISADE-2 is a randomized, multi-center, double-blind, placebo-controlled clinical trial that is a replicate of VistaGen’s ongoing PALISADE-1 trial of PH94B for the acute treatment of anxiety in adults with SAD. Both studies are designed in a manner that 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 have rapid reduction in anxiety (within 15 minutes) in response to a public speaking challenge (p=0.002). PALISADE-2 will be conducted across approximately 15 clinical sites in
“Following the successful initiation of PALISADE-1 last quarter, we are excited to be further advancing our PALISADE Phase 3 Program this quarter with the initiation of PALISADE-2, an essential next step in our efforts to further demonstrate the reduction in anxiety observed in PH94B’s Phase 2 clinical trials to date,” stated
PALISADE Phase 3
VistaGen’s PALISADE Phase 3 Program is designed to further demonstrate the potential of PH94B as a fast-acting, acute treatment of anxiety in adults with SAD. If successful, upon completion of the PALISADE Phase 3 Program, VistaGen plans to submit a New Drug Application to the FDA for PH94B for the acute treatment of anxiety in adults with SAD. PALISADE-1 and PALISADE-2 are replicate
About Social Anxiety Disorder (SAD)
Social anxiety disorder affects as many as 23.7 million Americans and, according to the
PH94B is a first-in-class, odorless, rapid-onset (approximately 15 minutes), pherine nasal spray with the potential to be the first FDA-approved, fast-acting, on-demand treatment for millions of Americans who suffer from SAD, with the potential to also treat adjustment disorder, postpartum anxiety, procedural anxiety, post-traumatic stress disorder, panic disorder and generalized anxiety disorder. Administered at microgram doses, PH94B activates nasal chemosensory neurons that trigger neural circuits in the brain that suppress fear and anxiety. Following successful completion of PH94B’s Phase 2 development, VistaGen initiated its PALISADE-1 and PALISADE-2 Phase 3 clinical trials of PH94B for the acute treatment of anxiety in adults with SAD. The FDA has granted Fast Track designation for the development of PH94B for the acute treatment of anxiety in adults with SAD.
Forward Looking Statements
Various statements in this release are "forward-looking statements" concerning VistaGen's future expectations, plans and prospects, including the potential for successful Phase 3 development of PH94B for the acute treatment of anxiety in adults with SAD. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: completion of PALISADE-1 and/or PALISADE-2 may be delayed due to a variety of factors, including factors related to the ongoing COVID-19 pandemic; development and approval of PH94B may not be achieved in any market; the FDA may decide that the results of PALISADE-1 and PALISADE-2 and other studies in VistaGen's PALISADE PH94B Phase 3 Program are not sufficient to support a New Drug Application, or for regulatory approval for the acute treatment of anxiety in adults with SAD or any other anxiety-related disorder; development of PH94B may not be successful in any indication; success in nonclinical studies or in earlier-stage clinical trials may not be repeated or observed at any time during the PALISADE Phase 3 Program, including during PALISADE-1 or PALISADE-2, or future trials, which trials may not support further development or be sufficient to gain regulatory approval to market PH94B; and adverse events may be encountered at any stage of development that negatively impact further development. Other risks and uncertainties include, but are not limited to, issues related to: adverse healthcare reforms and changes of laws and regulations; general industry and market conditions; manufacturing and marketing risks, which may include, but are not limited to, unavailability of or delays in manufacture of PH94B; inadequate and/or untimely supply of PH94B to meet demand; entry of competitive products; and other technical and unexpected hurdles in the development, manufacture and commercialization of PH94B, as well as those risks more fully discussed in the section entitled "Risk Factors" in VistaGen’s most recent Annual Report on Form 10-K for the year ended
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Source: VistaGen Therapeutics, Inc.