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Vistagen Announces First Participants Dosed in Phase 1 Clinical Trial of PH10, an Investigational Pherine Nasal Spray for Major Depressive Disorder
Small U.S. Phase 1 trial with newly optimized formulation to confirm favorable safety profile from three previous clinical trials and facilitate Phase 2B
About this update from Vistagen Therapeutics, Inc.
[{"type":"text","content":"\nSmall U.S. Phase 1 trial with newly optimized formulation to confirm favorable safety profile from three previous clinical trials and facilitate Phase 2B development of PH10 as a stand-alone treatment for major depressive disorder\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 the first cohort of healthy volunteers has been dosed in its U.S. Phase 1 clinical trial of PH10, the Company’s investigational pherine nasal spray in development for the treatment of major depressive disorder (MDD).\n\nThe primary objective of this U.S. single center, randomized, double-blinded, placebo-controlled Phase 1 study is to investigate the safety and tolerability of PH10 in healthy adult subjects (n=12). The study is intended to confirm the favorable safety profile of PH10 established in three previous clinical studies conducted in Mexico, including a published Phase 2A study for the treatment of MDD, as well as facilitate Vistagen’s plans for Phase 2B development of PH10 as a stand-alone treatment for MDD. Vistagen anticipates completion of the study by the end of Q1 2023, with top line results expected before the end of the first half of 2023.\n\n“The initiation of this U.S. Phase 1 study of Vistagen’s novel pherine nasal spray, PH10, represents a major milestone for our team as well as for the millions of individuals left struggling with major depressive disorder,” stated Shawn Singh, Chief Executive Officer of Vistagen. “We expect this Phase 1 trial to augment our record of favorable safety and tolerability data for PH10 across all prior clinical studies. Upon completion of the study and subsequent data readout, we will seek feedback from the FDA regarding potential Phase 2B development of PH10 as a stand-alone treatment for major depressive disorder, building on past success in the Phase 2A clinical program.”\n\nAbout PH10\n\nPH10 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. PH10, which is administered at microgram-level doses, is design...