Vistagen announces new itruvone data

Vistagen announced 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 was essentially 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, and thereby limiting transport of molecules to the circulatory system and minimizing potential systemic exposure. Vistagen recently reported that itruvone is now staged for potential Phase 2B clinical development in the U.S. as a stand-alone treatment for MDD, building on previously published results from a randomized, double-blind, placebo-controlled Phase 2A study of itruvone in MDD. In that study, itruvone was administered intranasally at a daily dose of 3.2 microgram and 6.4 microgram for 8 weeks. After one week of treatment, the mean reduction on the 17-item Hamilton Depression Scale scores for the itruvone 6.4 microgram group was 10.1 points, which was statistically greater than the mean reduction in the placebo group of 4.2 points from baseline. Also, at the end of the last week of treatment in that study, the itruvone 6.4 microgram 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. Thus, in the itruvone 6.4 microgram treatment group, the HAM-D-17 score improved significantly from the baseline within one week and this effect was sustained until the Week 8 study endpoint. Notably, both the itruvone 3.2 microgram and 6.4 microgram treatment groups showed strong effect sizes after one week of treatment and at the Week 8 study endpoint. There were no reports of SAEs. Itruvone was well-tolerated and did not cause psychological side effects or other safety concerns that may be associated with other approved pharmacological therapies for MDD.