Vistagen Starts Phase 1 Clinical Trial of 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 development of PH10 as a stand-alone treatment for major depressive disorder

 

VistaGen Therapeutics, Inc. (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).

The 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.

https://www.biospace.com/article/releases/vistagen-announces-first-participants-dosed-in-phase-1-clinical-trial-of-ph10-an-investigational-pherine-nasal-spray-for-major-depressive-disorder/