Vistagen to Proceed with PALISADE-2 Phase 3 Clinical Trial of PH94B in Social Anxiety Disorder following Interim Analysis
Independent biostatisticians recommend continuing PALISADE-2 without any changes after conducting interim analysis of 140 completed subjects
Topline data for PALISADE-2 trial expected in the first half of 2023
Independent biostatisticians reviewed unblinded data from the 140 subjects who completed PALISADE-2 before the Company paused enrollment in the study in
“We are encouraged by the recommendation to continue PALISADE-2 to full enrollment as originally planned,” said
PH94B is an innovative, fast-acting, odorless pherine administered intranasally at microgram doses. It is currently in clinical trials to treat multiple anxiety disorders without the side effects and safety concerns associated with currently prescribed and off-label medications. PH94B demonstrated tolerability in PALISADE-1 that was consistent with reported results from previous clinical trials. No severe or serious adverse events were reported for PH94B in PALISADE-1 or PALISADE-2 or in other clinical trials.
Vistagen (Nasdaq: VTGN) is a late clinical-stage, CNS-focused biopharmaceutical company aiming 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. PH94B and PH10 belong to a new class of drugs known as pherines, which are odorless and tasteless investigational neuroactive steroid nasal sprays designed with a novel rapid-onset mechanism of action that activates chemosensory neurons in the nasal passages and can impact the olfactory-amygdala neural circuits without systemic uptake or direct activity on CNS neurons in the brain. 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.
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 and its management, are inherently uncertain. As with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization and actual 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 the Company’s PALISADE-2 Phase 3 clinical trial will be successful or that PH94B or any of the Company’s other drug candidates will receive regulatory approval or be commercially successful. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to resuming and completing the Company’s PALISADE-2 Phase 3 clinical trial; the effect, if any, of the previously announced topline results of the Company’s PALISADE-1 Phase 3 clinical trial; the completion and results of the Company’s ongoing clinical studies of PH94B, including the Company’s Phase 2A clinical trial of PH94B in adults experiencing adjustment disorder with anxiety; delays in launching, conducting and/or completing other ongoing and planned clinical trials, 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
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Vice President, Investor Relations