VistaGen's New Preclinical Depression Treatment Study: Itruvone Nasal Spray Limits Systemic Exposure, Shows Promise

Vistagen Inc VTGN revealed a 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 undetectable in the brain and most other tissues, including blood and plasma.

These 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, thereby limiting the transport of molecules to the circulatory system and minimizing potential systemic exposure.

Related: Social Anxiety Disorder Impacts Around 23.7M People In US, Vistagen Releases Details Around Nasal Spray Treatment Program For It.

Vistagen recently reported that itruvone is now staged for potential Phase 2B clinical development in the U.S. as a stand-alone treatment for major depressive disorder, building on previously published results of Phase 2A study of itruvone in MDD. 

After one week of treatment, the mean reduction on the 17-item Hamilton Depression Scale (HAM-D-17) scores for the itruvone 6.4 μg group was 10.1 points, which was statistically greater (p = 0.03) than the mean reduction in the placebo group of 4.2 points from baseline. 

Also, at the end of the last week of treatment (Week 8) in that study, the itruvone 6.4 μg group showed a mean HAM-D-17 score reduction of 17.8, which was statistically greater than the mean reduction in the placebo group of 10.9 points from baseline (p = 0.02). 

Price Action: VTGN shares are up 1.69% at $1.80 on the last check Monday.