Type: First-in-class rapid-onset neuroactive nasal spray, being developed as an anti-anxiety drug for treatment of seasonal adjustment disorder (SAD) with anxiety related to the COVID-19 pandemic
Status: VistaGen said May 18 it submitted its proposed protocol for a Phase IIA study of PH94B to the FDA through its new Coronavirus Treatment Acceleration Program (CTAP). The proposed Phase II Part A study will be conducted in New York City on an open-label basis, and involve approximately 30 subjects suffering from adjustment disorder from stressors related to the pandemic.
Michael R. Liebowitz, MD, a member of VistaGen’s CNS Clinical and Regulatory Advisory Board, will serve as Principal Investigator of the Phase II Part A study. He is a Professor of Clinical Psychiatry at Columbia University, and directs the Medical Research Network LLC in New York City.
Based on results of the Phase II Part A study, VistaGen has said, it plans to advance development to a Phase II Part B randomized, double-blind, placebo-controlled study of approximately 150 subjects.
In April, VistaGen said it will expand clinical development of PH94B to include treatment of adjustment disorder due to stressors related to COVID-19.
The FDA previously designated PH94B for Fast Track development for treatment of SAD, the first such designation by the FDA for a drug candidate for that indication. VistaGen said it has completed Phase II studies and is preparing for Phase III development of PH94B for treatment of SAD.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: