Drug Maker, Univ. Lab Partner on Neuropeptide Anxiety Trial

(Pixy.org)

17 July 2023. A biopharmaceutical company and university neuroscience lab are collaborating on a clinical trial testing a peptide nasal spray treatment for social anxiety disorder. The agreement brings together Tonix Pharmaceuticals Holding Corp. in Chatham, New Jersey and the neurobiology lab of Angela Fang at University of Washington in Seattle, but financial terms were not disclosed.

Tonix Pharmaceuticals develops treatments for a range of conditions affecting the immune and central nervous systems, as well as infections and rare diseases. One of the company’s experimental therapies, code-named TNX-1900, is currently in a clinical trial as a treatment for chronic migraine. TNX-1900 is a nasal spray formulation of the human hormone oxytocin, that Tonix Pharma says enhances binding to neuron receptors in the trigeminal ganglia to reduce electrical impulses and pain signals in a key pathway associated with migraine. But because the nasal spray-delivered oxytocin binds quickly to its targets in the brain, says the company, it also limits more general exposure in the body, thus with fewer risks of off-target adverse effects.

Tonix Pharma believes TNX-1900 can be applied to other neurological conditions marked by anxiety and social deficits. “In the past decade,” says co-founder and CEO Seth Lederman in a company statement, “there has been an increase in studies examining oxytocin’s effects on social cognition and behavior in animals and humans due to translational discoveries showing that intranasal oxytocin appears to reach central nervous system targets. Specifically, evidence suggests that oxytocin may enhance the importance of social cues or have anti-anxiety properties. These studies have shown that intranasal oxytocin may hold therapeutic promise for psychiatric disorders involving social deficits.”

Peptide associated with social cognition and bonding behaviors

Fang’s ConnectLab at University of Washington studies biological mechanisms in endocrinology and neuroscience behind social and emotional information processing associated with anxiety and obsessive-compulsive disorders. Among the lab’s investigations is effects of intranasal oxytocin in people with anxiety and related disorders. Oxytocin is a neurotransmitter peptide released by neurons in the hypothalamus, and associated with a range of social cognition and bonding behaviors.

In their collaboration, Tonix Pharma and Fang are assessing TNX-1900 as a treatment for social anxiety disorder, a condition marked by an intense and continuing fear of being judged by others. The disorder often forms in late childhood and affects more females than males. “Social anxiety disorder is a disabling psychiatric disorder,” notes Fang. “Past research has focused on the observational, or vicarious, acquisition of fears, but little is known about how social information, such as observing others experiencing safety, can promote safety learning.”

Fang and Tonix Pharma are collaborating on a mid-stage clinical trial evaluating TNX-1900 for generating vicarious extinction learning among people with social anxiety disorder. Vicarious extinction occurs when observational experiences are able to overcome fears and associated avoidance behaviors. In the trial, 50 participants with social anxiety disorder are matched demographically to 50 healthy individuals. The participants will be randomly assigned to receive a single dose of TNX-1900 or a placebo nasal spray, with measures of social anxiety and vicarious extinction taken periodically. The trial is not yet registered with ClinicalTrials.gov.

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