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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