VistaGen’s horizons may shrink after clinical trial setback

by Stephen Riddle

Shares in VistaGen Therapeutics have plummeted after the company reported that its lead pherine nasal spray candidate failed the first of two phase 3 trials in social anxiety disorder (SAD), placing the future of the programme in doubt.

The drug – codenamed PH94B – was unable to alleviate SAD symptoms in adults asked to complete a public speaking challenge in the PALISADE-1 compared to placebo.

The announcement of the result was swiftly followed by an 86% decline in VistaGen’s share price, reflecting investor concerns about the potential of PH94B, which is in multiple trials across SAD indications and is the company’s primary R&D programme.

The company is now firmly in penny share territory at $0.15, down from a 52-week high of more than $3.25.

The South San Francisco biotech’s chief executive, Shawn Singh, said that while the results of PALISADE-1 were “not consistent” with earlier, phase 2 trials of PH94B in SAD, the company remains “committed to transforming the treatment landscape for those living with anxiety, depression, and other central nervous system disorders.”

In PALISADE-1, a single dose of PH94B showed no difference from placebo on the self-reported Subjective Units of Distress Scale (SUDS) scores given 20 minutes before a public speaking task.

Attention now turns to the PALISADE-2 trial, another public speaking challenge study, and a phase 2 study in people with anxiety and adjustment disorder – a reaction to a change in circumstance that can lead to feelings of being overwhelmed and unable to concentrate.

There had been high hopes for the outcome of PALISADE-1, after a mid-stage trial  demonstrated a statistically significant difference with placebo on both public speaking and social interaction. That earned it fast-track status by the FDA.

The latest result has undermined the company’s hopes that PH94B would become the first FDA-approved, on-demand treatment for patients who suffer from SAD, but it’s not the first setback for the company.

In 2019, VistaGen reported that its ketamine-like drug AV-101B failed a phase 2 trial in major depressive disorder (MDD), sending the programme back into early-stage clinical development and leading to another rout of its shares.

AV-101 was being administered in its own in that trial, and is now being co-administered with oral probenecid in a phase 1b study, in an attempt to improve its delivery over the blood-brain barrier and restore its promise in MDD.

VistaGene meanwhile is also developing PH10, another pherine nasal spray heading for a phase 2b study in MDD.

Image by Rudy and Peter Skitterians from Pixabay 

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