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Vistagen Announces Results of Successful U.S. Phase 1 Study of Itruvone (PH10), Enabling U.S. Phase 2B Development for Treatment of Major Depressive Disorder
The U.S. Phase 1 data build on successful Phase 1 and Phase 2A clinical studies of itruvone previously conducted outside the U.S. Itruvone was well-tolerated
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"\nThe U.S. Phase 1 data build on successful Phase 1 and Phase 2A clinical studies of itruvone previously conducted outside the U.S.\n\n\nItruvone was well-tolerated and demonstrated a favorable safety and tolerability profile across single and multiple dose intranasal administrations\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 favorable safety and tolerability data from its U.S. Phase 1 clinical trial of itruvone (PH10), the Company’s investigational rapid-onset pherine nasal spray for the treatment of major depressive disorder (MDD). Results from the U.S. Phase 1 study build on successful Phase 1 studies and a positive randomized, double-blind, placebo-controlled Phase 2A study of itruvone nasal spray in MDD previously conducted in Mexico and enable Phase 2B development of itruvone in the U.S. as an innovative stand-alone rapid-onset product candidate for treatment of MDD.\n\n\nThe U.S. Phase 1 study was a randomized, double-blind, placebo-controlled clinical study investigating the safety and tolerability of a single dose and of multiple doses of itruvone nasal spray in healthy adult subjects. There were no reported serious adverse events (SAEs) or discontinuations due to adverse events (AEs) in the study. Two AEs were reported during the treatment period, fatigue and headache, which occurred in the same subject. Both AEs were mild in severity and resolved without sequelae. Overall, itruvone nasal spray was well-tolerated and demonstrated a favorable safety profile, consistent with the three prior clinical studies of itruvone, including a positive randomized, double-blind, placebo-controlled Phase 2A study in MDD.\n\n\n“According to a recent Gallup survey, more than a quarter of American adults have been diagnosed with depression at some point in their lifetime. The need for faster-acting, safer and more effective medications is unrelenting, especially in an environment where the gap between innovative treatment options and the prevalence of depressive disorders is increasing,” stated Shawn Singh, Chief Executive Officer of Vistagen. “With a successful Phase 1 study in the U.S. and a positiv...