- Clinical-stage biotech VistaGen Therapeutics ( NASDAQ: VTGN ) announced on Friday that the company’s PALISADE-1 Phase 3 clinical trial for anxiety therapy PH94B did not meet the primary endpoint. After a brief trading halt, VistaGen ( VTGN ) shares crashed 80% in the pre-market on the news.
- The multi-center, placebo-controlled study was designed to evaluate PH94B for acute treatment of anxiety in adults with the social anxiety disorder (SAD), a condition that affects an estimated 25M Americans.
- According to its topline data, PALISADE-1 did not achieve the primary endpoint for PH94B vs. placebo as measured by the change of a clinical standard called the Subjective Units of Distress Scale (SUDS).
- However, VistaGen ( VTGN ) said that the experimental therapy was found to have a tolerability profile in line with prior data from all other clinical studies.
- Citing its ongoing PALISADE-2 Phase 3 trial, the company reiterated its commitment to advance PH94B as a treatment for SAD.
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In May, VistaGen ( VTGN ) said that the FDA agreed the drug did not indicate any potential for abuse.
For further details see:
VistaGen drops 80% as late-stage study for anxiety therapy fails