VistaGen Therapeutics has licensed Pherin Pharmaceuticals' lead candidate, a phase 3-ready treatment for social anxiety disorder (SAD). Under the deal, VistaGen issued Pherin $2.25 million of unregistered common stock and received the option to license an additional phase 2 asset from Pherin.
The drug, PH94B, like Pherin’s other candidates, is a “pherine,” a synthetic neuroactive steroid targeting chemosensory receptors in the nose, which then inhibit nerve circuits involved in the behavioral and physiological effects of anxiety. It is a nasal spray that can be self-administered and is intended to be used as an as-needed treatment.
“This agreement provides a meaningful opportunity to continue our clinical progress and advance our mission to bring novel treatment alternatives to the many individuals affected with SAD. We are confident VistaGen will build upon our earlier clinical studies, which provided impressive evidence of rapid (10-15 minutes) anxiety reduction for subjects with SAD,” said Louis Monti, executive vice president at Pherin.
In addition to easy delivery and quick onset of efficacy, PH94B has been shown to be safer compared to other treatments that “require chronic dosing and have concurrent side effects,” Monti said.
The National Institute of Mental Health estimates 12.1% of adults in the U.S. experience SAD at some time in their lives. It is usually treated with therapy, medication or both.
“Currently, there is no FDA-approved treatment that provides rapid-acting relief, and sedatives used off-label carry with them the risk of addiction and other significant side effects and safety concerns,” said VistaGen CEO Shawn Singh.
The deal adds SAB to the central nervous system indications VistaGen is targeting in its pipeline. The company’s small-molecule prodrug, AV-101, is being tested in major depressive disorder, suicidal ideation, neuropathic pain, Parkinson’s disease and epilepsy. It is currently in the preclinical stage for Huntington disease.
While VistaGen and Pherin are tackling social anxiety through the nose, Biohaven Pharmaceutical is going under the tongue. In August, the company reported data from a 21-patient trial of a new formulation of the ALS drug riluzole. People with SAD were asked to carry out a 10-minute public speaking task after taking riluzole or placebo an hour beforehand. The glutamate-modulating drug achieved a significant reduction in anxiety based on a 100-point symptom scale, reducing it by eight points compared to placebo, with a 14-point relative improvement from baseline.