Business
Vistagen Reports New Preclinical Data Supporting Itruvone (PH10) Nasal Spray’s Potential Antidepressant Activity via Peripheral Nasal Neurons without Entry into the Brain
Preclinical study of radiolabeled intranasal itruvone in laboratory rats further validates itruvone’s potential to treat major depressive disorder (MDD)
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"\nPreclinical study of radiolabeled intranasal itruvone in laboratory rats further validates itruvone’s potential to treat major depressive disorder (MDD) without systemic absorption\n\n\n SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--\nVistagen (NASDAQ: VTGN) a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with 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. The study demonstrated that a single intranasal administration of radiolabeled itruvone ([14C]PH10) was essentially undetectable in the brain and most other tissues, including blood and plasma.\n\n\nThese new data further support the proposed mechanism of action of itruvone nasal spray as involving binding to receptors of peripheral chemosensory neurons in the nasal cavity, but not to neuronal receptors in the CNS, and thereby limiting transport of molecules to the circulatory system and minimizing potential systemic exposure.\n\n\n“Itruvone’s unique mechanism of action is further demonstrated in this new carbon-labeled study,” said Shawn Singh, Chief Executive Officer of Vistagen. “These new data and previously announced preclinical electrophysiology data demonstrating that itruvone’s mechanism of action does not involve direct activation of GABA-A receptors in the brain, as well as other completed Phase 1 and Phase 2A clinical studies, provide a substantial body of evidence supporting itruvone’s exceptionally favorable safety profile. Currently approved medications to treat depression require systemic absorption. This can lead to unwanted side effects and create potential drug-drug interaction concerns for some individuals who require additional medications for other medical conditions. As a potential non-systemic treatment option, we believe itruvone has a vital opportunity to change the treatment paradigm for the growing numbers of individuals suffering from depression disorders across the globe.”\n\n\nVistagen recently reported that itruvone is now staged for potential Phase 2B clinical development in the U.S. as a stand-alone treatment for MDD, building on previously published results from a randomized, double-blind, placebo-controlled Phase 2A study of itruvone in MDD. In...