Tonix Pharmaceuticals announced that Massachusetts General Hospital has initiated a Phase 1 trial called FOCUS to evaluate Tonix’s TNX-1900 and TNX-2900 oxytocin nasal sprays in patients with arginine-vasopressin deficiency (central diabetes insipidus). The FOCUS study is expected to enroll 40 patients and will evaluate the effect of a single dose of TNX-1900 versus TNX-2900 versus placebo on anxiety, depression, and socio-emotional functioning.
TNX-1900 is currently in development for the treatment of migraines, and Tonix recently announced plans to move ahead with a Phase 2 trial of TNX-2900 in patients with Prader-Willi syndrome (PWS). In 2020, the company acquired a license from the University of Geneva to develop intranasal potentiated oxytocin for the treatment of insulin resistance.
Tonix CEO Seth Lederman commented, “Patients with AVP-D often experience mental health and quality-of-life challenges that are not adequately addressed by current interventions. Oxytocin plays an important role in regulating mood and socio-emotional functioning, and evidence suggests that AVP-D is associated with oxytocin deficiency. We are pleased to support the FOCUS study at MGH, which will evaluate our investigational intranasal potentiated oxytocin products TNX-1900 / TNX-2900 in this population and may help lay the groundwork for future studies of oxytocin replacement therapy.”
Read the Tonix Pharmaceuticals press release
