VistaGen Proclaims Finest Outcomes from Part 3 PALISADE-1 Medical Trial for Investigational Drug PH94B

PH94B for the acute therapy of social anxiousness dysfunction didn’t meet the first endpoint

PH94B confirmed a good security and tolerability profile amongst examine members that was in keeping with outcomes from earlier medical trials

SOUTH SAN FRANCISCO, California, July 22, 2022–(BUSINESS WIRE)–VistaGen Therapeutics, Inc. (Nasdaq: VTGN) (VistaGen, the Firm), a late-stage biopharmaceutical firm that goals to remodel the therapy panorama for individuals residing with anxiousness, melancholy and different problems of the central nervous system. central nervous system (CNS) problems, at this time introduced the principle outcomes of its Part 3 PALISADE-1 medical trial of PH94B for the acute therapy of hysteria in adults with social anxiousness dysfunction. PH94B didn’t meet its main endpoint, as measured by change from baseline utilizing the Subjective Misery Unit Scale (SUDS) in comparison with placebo. Though the trial didn’t meet its main endpoint, the tolerability profile of PH94B in PALISADE-1 was favorable and in keeping with beforehand reported outcomes from all different medical trials. No extreme or critical adversarial occasions had been reported for PH94B in earlier medical trials or in PALISADE-1.

“The demand for brand spanking new therapy choices for anxiousness problems is massive and rising. Whereas the outcomes from PALISADE-1 usually are not in keeping with earlier optimistic outcomes from Part 2 trials of PH94B in social anxiousness dysfunction, we proceed to dedicated to reworking the therapy panorama for these residing with anxiousness, melancholy and different central nervous system problems,” mentioned Shawn Singh, CEO of VistaGen. “As a part of this dedication, our workforce will proceed to pursue the potential of PH94B as a brand new therapy choice for a number of anxiousness problems, together with for the acute therapy of social anxiousness dysfunction in our ongoing Part 3 PALISADE-2 trial and for continued use in our ongoing trial Part 2 Trial in Adjustment Dysfunction with Nervousness We want to thank the sufferers and investigators for his or her participation within the trial, and we are going to proceed to judge the detailed information from PALISADE-1 as we transfer ahead with our research. trials in progress.

PALISADE-1 was a multicenter, randomized, double-blind, placebo-controlled, parallel-design, Part 3 medical examine in adults recognized with social anxiousness dysfunction (SAD). The examine was designed to judge the efficacy, security, and tolerability of acute administration of PH94B in relieving anxiousness signs in grownup sufferers with SAD throughout a simulated public talking problem, measured utilizing the patient-reported SUDS. Earlier than the general public talking problem, topics had been randomized to obtain both a single dose of PH94B or a placebo.

VistaGen has three drug candidates in its CNS portfolio, PH94B, PH10 and AV-101, with the potential to transcend the present commonplace of take care of anxiousness, melancholy and different CNS problems. Every of the Firm’s drug candidates has a definite potential mechanism of motion, has been nicely tolerated in all medical research so far, and has therapeutic potential in a number of CNS markets.

About social anxiousness dysfunction

Social anxiousness dysfunction (SAD) impacts about 25 million Individuals. An individual with SAD experiences intense and chronic signs of hysteria or worry in sure social conditions, akin to assembly new individuals, making feedback in a enterprise assembly, occurring dates, being in a job interview, answering a query in school, or speaking to a ATM. within the store. Doing peculiar, on a regular basis issues in entrance of individuals may cause deep anxiousness or worry of being embarrassed, evaluated, humiliated, judged, or rejected. SAD can get in the way in which of going to work, attending college, or doing all kinds of issues in a scenario that’s more likely to contain interpersonal interplay. It will probably result in avoidance and alternative prices that may considerably have an effect on an individual’s employment and social actions and be very detrimental to their general high quality of life. SAD is usually handled long-term with sure FDA-approved antidepressants, which have a slow-onset impact (a number of weeks) and supply restricted therapeutic profit, and benzodiazepines, which aren’t FDA-approved for the therapy of SAD. Each antidepressants and benzodiazepines have recognized unwanted side effects and vital security considerations that may make them unattractive to individuals affected by SAD.

About VistaGen

VistaGen (Nasdaq: VTGN) is a late-clinical, central nervous system-focused biopharmaceutical firm striving to remodel the therapy panorama for individuals residing with anxiousness, melancholy and different central nervous system problems. VistaGen’s CNS product portfolio consists of three CNS drug candidates, PH94B, PH10 and AV-101, with the potential to transcend the present commonplace of take care of CNS indications with excessive unmet want. Every of the Firm’s drug candidates has a definite potential mechanism of motion, has been nicely tolerated in all medical research so far, and has therapeutic potential in a number of CNS markets. PH94B is an investigational first-of-its-kind pertussis nasal spray in Part 3 growth for the acute therapy of hysteria in adults with social anxiousness dysfunction and in Part 2 growth for adjustment dysfunction with anxiousness. VistaGen can be contemplating PH94B for medical growth in extra acute (on-demand) and ongoing use anxiousness problems, together with procedural anxiousness, panic dysfunction, postpartum anxiousness, and post-traumatic stress dysfunction. PH10 is an investigational pertussis nasal spray in medical growth as a stand-alone therapy for main depressive dysfunction and probably many different depression-related problems. AV-101 is an investigational oral prodrug of 7-chlorokynurenic acid (7-Cl-KYNA), a potent and selective whole antagonist of the glycine coagonist website of NMDAR, in medical growth with potential to grow to be a brand new oral agent. therapy various for sure CNS indications involving NMDAR. Join at www.VistaGen.com.

Ahead-looking statements

This press launch accommodates sure forward-looking statements inside the which means of the federal securities legal guidelines. These forward-looking statements contain recognized and unknown dangers which can be troublesome to foretell and embrace all issues that aren’t historic details. In some circumstances, you possibly can determine forward-looking statements by means of phrases akin to “might”, “might”, “count on”, “mission”, “outlook”, “technique”, “intend”, “plan”, “search” , “anticipate”, “imagine”, “estimate”, “predict”, “potential”, “endeavour”, “goal”, “proceed”, “seemingly”, “will”, “would” and variations of those phrases and comparable expressions, or the unfavourable of those phrases or comparable expressions. Such forward-looking statements are essentially primarily based on estimates and assumptions that, whereas thought-about affordable by VistaGen and its administration, are inherently unsure. As with all pharmaceutical product, there are substantial dangers and uncertainties within the growth and commercialization course of. and precise outcomes or developments might differ materially from these projected or implied by these forward-looking statements. Amongst different issues, there could be no assure that PH94B or any of the Firm’s different drug candidates will obtain regulatory approval or be commercially profitable. Different elements which will trigger such a distinction embrace, however usually are not restricted to, dangers and uncertainties associated to the outcomes of the Firm’s Part 3 PALISADE-1 medical trial reported on this information launch; the completion and outcomes of the Firm’s ongoing medical research of PH94B, together with the Part 3 PALISADE-2 medical trial and the Firm’s Part 2A medical trial of PH94B in adults experiencing adjustment dysfunction with anxiousness; delays in launching, conducting and/or finishing different ongoing and deliberate medical trials, together with delays as a result of influence of the continuing COVID-19 pandemic; fluctuating prices of supplies and different sources essential to conduct the Firm’s ongoing and/or deliberate medical and non-clinical trials; market circumstances; the influence of basic financial, industrial or political circumstances in the US or internationally; and different technical and sudden obstacles within the growth, manufacturing and commercialization of the corporate’s CNS drug candidates. These dangers are absolutely mentioned within the part entitled “Danger Elements” within the Firm’s most up-to-date Annual Report on Kind 10-Okay for the fiscal yr ended March 31, 2022, in addition to potential dangers , the uncertainties and different necessary elements in our different filings with the US Securities and Alternate Fee (SEC). The Firm’s filings with the SEC can be found on the SEC’s web site at www.sec.gov. You shouldn’t place undue reliance on these forward-looking statements, which apply solely as of the date of this press launch and shouldn’t be construed as representing the views of the Firm as of any later date. The Firm expressly disclaims any obligation to replace any forward-looking assertion, besides as required by legislation. If the Firm updates a number of forward-looking statements, it shouldn’t be inferred that the Firm will make any additional updates with respect to these or different forward-looking statements.

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contacts

Traders:
model flather
Vice President, Investor Relations
(650) 577-3617
mflather@vistagen.com

Media:
nate hitches
SDK
nhitchings@skdknick.com

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