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Vistagen Announces Completion of Last Patient, Last Visit in Phase 1 Clinical Trial of Itruvone (PH10), an Investigational Pherine Nasal Spray for Major Depressive Disorder
U.S. Phase 1 study with newly optimized formulation intended to facilitate Phase 2B development of itruvone as a stand-alone treatment of major depressive
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"\nU.S. Phase 1 study with newly optimized formulation intended to facilitate Phase 2B development of itruvone as a stand-alone treatment of major depressive disorder\n\nTop line results anticipated in Q2 2023\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 that the last participant has completed the study protocol in its U.S. Phase 1 clinical trial of itruvone (PH10), the Company’s investigational pherine nasal spray for the treatment of major depressive disorder (MDD).\n\nThe primary objective of this U.S. single-center, randomized, double-blind, placebo-controlled Phase 1 study is to investigate the safety and tolerability of itruvone in healthy adult subjects. The study is intended to confirm the favorable safety profile of itruvone established in three previous clinical studies conducted in Mexico, including a published Phase 2A study of itruvone as a stand-alone treatment of MDD, as well as facilitate Phase 2B development of itruvone as a stand-alone treatment for MDD. Vistagen anticipates top line results in Q2 2023.\n\n“With the treatment protocol for our final enrolled participant complete, we look forward to reviewing the data and advancing Phase 2B development plans for itruvone as an innovative treatment for major depressive disorder,” said Shawn Singh, Chief Executive Officer of Vistagen. “Major depressive disorder continues to disrupt the lives of millions of individuals and there is clear need for safer, more effective treatments, especially treatments with potential for rapid-onset and sustained benefits without causing sexual side effects or weight gain. We anticipate this U.S. Phase 1 trial will build on itruvone’s exceptional safety and tolerability profile as demonstrated in all prior clinical studies to date.”\n\nAbout Itruvone (PH10)\n\nItruvone (PH10) is an investigational pherine nasal spray designed with a potential rapid-onset mechanism of action (MOA) that is fundamentally differentiated from the MOA of all currently approved treatments for depression disorders. Itruvone, which is administered at microgram-level doses, is designed to engage and activate chemosensory neurons...