History repeats for Vistagen

In 2019 Vistagen’s NMDA receptor antagonist AV-101 failed dismally in depression, scything 72% off the company’s share price. Today history repeated itself, though this time the project in question is PH94B, Vistagen’s nasal spray for anxiety, and the share price fall is 84%. The phase 3 Palisade-1 trial was assessing PH94B’s use for the acute treatment of anxiety in adults with social anxiety disorder, and aimed to show an improvement from baseline on the Subjective Units of Distress Scale (SUDS) during a simulated public speaking challenge. The fact that PH94B was no better than placebo in the trial has not put Vistagen off. The company is continuing both with Palisade-2, also in acute anxiety, and with a phase 2 trial of PH94B in adjustment disorder with anxiety, but shareholders clearly hold out little hope. Otherwise Vistagen has two other candidates: PH10, a pherine nasal spray for major depressive disorder which does not appear to be in any active studies, according to clincialtrials.gov; and AV-101, the project that failed three years ago. 

Vistagen's ongoing clinical trials
Phase Details N Status NCT ID
Phase 3 Palisade-1 - PH94B vs pbo for anxiety induced by a public speaking challenge 209 Failed Jul 2022 NCT04754802
Phase 3 Palisade-2 - PH94B vs pbo for anxiety induced by a public speaking challenge 208 Data due 2022 NCT05011396
Phase 3 Open-label safety trial of PH94B in social anxiety disorder 600 Data due 2023 NCT05030350
Phase 2 PH94B vs pbo in the treatment of adjustment disorder with anxiety 40 Data due 2022 NCT04404192
Phase 2 Elevate - AV-101 vs pbo in patients with major depression 180 Failed 2019 NCT03078322
Phase 2 AV-101 vs pbo in Parkinson’s disease subjects with levodopa-induced dyskinesia 20 Data due 2023 NCT04147949
Source: Evaluate Pharma, Clinicaltrials.gov.

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