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VistaGen Therapeutics Reports New Preclinical Mechanism of Action Data Supporting PH94B’s Potential Anti-Anxiety Activity via Peripheral Nasal Neurons without Entry into the Brain
Preclinical study of intranasal radiolabeled PH94B in laboratory rats further differentiates PH94B’s mechanism of action from benzodiazepines SOUTH SAN

About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"Preclinical study of intranasal radiolabeled PH94B in laboratory rats further differentiates PH94B’s mechanism of action from benzodiazepines\nSOUTH SAN FRANCISCO, Calif., Oct. 05, 2021 (GLOBE NEWSWIRE) -- VistaGen Therapeutics (NASDAQ: VTGN), a biopharmaceutical company developing a new generation of medicines with potential to go beyond the current standard of care for anxiety, depression and other central nervous system (CNS) disorders, today announced new mechanism of action data from a preclinical tissue distribution study in laboratory rats demonstrating that a single intranasal administration of radiolabeled carbon-14 PH94B ([14C]PH94B) was largely confined to the nasal passages and minimal or undetectable in most other tissues, including the CNS. No appreciable activity was observed in the brain. These data further support the proposed mechanism of action of PH94B involving binding to receptors of peripheral neurons in the nasal passages, not to neuronal receptors in the CNS, and thereby limiting transport of molecules to the circulatory system and minimizing potential systemic exposure. \"We are very excited about these new study results, which further highlight how the mechanism of action of PH94B is fundamentally differentiated from all current anti-anxiety therapies,\" stated Shawn K. Singh, Chief Executive Officer of VistaGen. \"When combined with previously announced preclinical electrophysiology data demonstrating that the mechanism of action of PH94B does not involve direct activation of GABA-A receptors, which is in distinct contrast to the mechanism of action of benzodiazepines, we see a growing body of evidence suggesting that PH94B has potential to achieve anti-anxiety effects without requiring systemic uptake or causing benzodiazepine-like side effects and safety concerns. At a time when the current drug treatment paradigm for Social Anxiety Disorder, or SAD, is falling far short of delivering necessary relief without worrisome potential consequences, an innovative treatment alternative is imperative. If successfully developed in our ongoing PALISADE Phase 3 Program, PH94B has the potential to fill that void as the first fast-acting, on demand acute treatment of anxiety for more than 23 million Americans who suffer from SAD.\" \"In this study, the absence of radiolabeled PH94B in the rodent brain is an encou...