San Francisco-based VistaGen Therapeutics has signed a licensing and collaboration agreement with Shanghai-headquartered EverInsight Therapeutics.
Under the deal, EverInsight will take over the development and commercialisation of VistaGen’s rapid-onset nasal spray drug, PH94B, for a range of anxiety-related disorders in Greater China, South Korea and Southeast Asia.
VistaGen will retain exclusive rights to PH94B in other global markets, including the US, however.
VistaGen will receive $5m upfront in return for EverInsight taking over activities for PH94B in the three Asian markets. This funding will be used to support “development activities aimed at advancing our pipeline,” explains VistaGen CEO Shawn Singh.
Social anxiety disorder is a common, chronic disorder that often plagues sufferers in adolescence and for decades beyond. In the modern world of “social media, as well as increased team orientation in academic settings and the workplace”, there is an even greater need for better solutions, says Singh.
“Benzodiazepines or ‘benzos’ such as lorazepam, alprazolam and diazepam, and beta blockers, such as propranolol, are prescribed off-label (not FDA-approved) for SAD, but have serious potential side effects, such as addiction, sedation, cognitive impairment and/or potential cardiac safety concerns.”
Therapies for social anxiety disorder are needed “in anticipation of a particular anxiety-provoking situation”, meaning “a safe, non-systemic, non-addicting, non-sedating, rapid-acting anti-anxiety medication is necessary to fulfil the unmet medical need,” says Singh.
This is precisely what PH94B offers, according to Singh. “Based on data from all clinical studies to date, we believe our PH94B nasal spray has breakthrough potential to be an easy-to-self-administer, first-in-class neurosteroid with a novel, fast-acting mechanism of action that can be effective for treating social anxiety disorder within 10 to 15 minutes,” he says.
“We envision PH94B as a fast-acting anti-anxiety medication that can be removed from a purse, briefcase or backpack as needed from time to time before an often predictable anxiety-provoking social or performance situation that is challenging for an individual with social anxiety disorder.”
VistaGen also believes that – for similar reasons and particularly linked to its excellent safety profile, a real rarity in mental health treatments – PH49B has the potential to treat other anxiety disorders.
The neuroactive drug is currently in Phase I and II studies for generalised anxiety disorder, adjustment disorder with anxiety, postpartum anxiety, perioperative anxiety, panic disorder and post-traumatic stress disorder.