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Will SAD Trial Make VistaGen Investors Happy?

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Social anxiety disorder, also known as social phobia, is one of the most prevalent mental health conditions in the U.S., affecting as many as 20 million Americans. Antidepressants, Benzodiazepines, and Beta Blockers are currently used to treat social anxiety disorder (SAD). However, there no FDA-approved medication for as-needed, on-demand treatment for this condition. Moreover, the current treatment options for social anxiety disorder are associated with a number of limitations.

VistaGen Therapeutics Inc. (VTGN) is developing a product for social anxiety disorder - PH94B - which has demonstrated a significant improvement in the primary efficacy endpoint as assessed using subjective anxiety ratings on the Subjective Units of Distress Scale (SUDS), within 10-15 minutes of self-administration in a phase II trial.

PH94B, an innovative odorless synthetic neuroactive steroid nasal spray, does not involve direct activation of GABA-A receptors, in distinct contrast to the mechanism of action of benzodiazepines ("benzos"), which act as direct positive modulators of GABA-A receptors.

The company expects to begin a phase III study of PH94B as an acute treatment of anxiety for adults with Social Anxiety Disorder in North America next quarter. A global phase III trial of PH94B is expected to begin in the fourth quarter.

PH94B is also being explored in other indications and phase IIa trials of this product in the indications of Adjustment Disorder, Pre-procedural Anxiety, PTSD, Postpartum Anxiety, and Panic Disorder are under preparation.

Also in the pipeline are PH10 for Depression Disorders and AV-101 for Neurological Disorders.

PH10, which is also a neuroactive nasal spray, has successfully completed a phase IIa program in Major Depressive Disorder.

AV-101, an oral drug candidate, is being evaluated as a potential treatment for Major Depressive Disorder, Neuropathic Pain, Levodopa-induced Dyskinesia, Epilepsy, and Suicidal Ideation.

VistaGen's phase II study of AV-101 as an adjunctive treatment of major depressive disorder, dubbed ELEVATE, the results of which were announced in November 2019, had failed to meet the primary endpoint.

Based on successful preclinical studies involving oral AV-101 alone and in combination with intravenous probenecid, the company plans to launch phase Ib clinical trials later this year.

Cash position:

At December 31, 2020, the company had cash and cash equivalents of roughly $104.3 million.

VTGN closed Thursday's trading at $2.48, up 20.39%.

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