Vistagen Therapeutics announced this week that it will proceed with its Phase 3 clinical trial assessing drug candidate PH94B for adults with Social Anxiety Disorder (SAD), after an independent team of biostatisticians evaluated trial results and recommended that the study should continue as planned.
Following disappointing results from a previous trial, PALISADE-1, the company recruited independent scientists to conduct an interim analysis and map out the best course of action for PALISADE-2. Notably, PH94B demonstrated tolerability in the PALISADE-1 trial, and no severe or serious adverse events were reported.
The company is focused on developing central nervous system therapeutics to ‘transform the landscape for individuals living with anxiety, depression, and other central nervous systems (CNS) disorders.” Vistagen says it’s specifically focused on producing drugs that are faster-acting than those that are currently available.
Currently, Vistagen is betting on PH04B and PH10, which both belong to a new class of drugs known as pherines, an odourless and tasteless investigational neuroactive steroid nasal spray that activates chemosensory neurons in the nasal passages and can affect the olfactory-amygdala neural circuits without affecting the rest of the body, or direct activity on CNS neurons.