Sunovion and Otsuka Initiate Clinical Development of Ulotaront for the Treatment of Generalized Anxiety Disorder

Sunovion Pharmaceuticals and Otsuka Pharmaceutical Development & Commercialization today announced that the first patient has been randomized in a Phase 2/3 clinical study evaluating ulotaront, a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity, for the treatment of generalized anxiety disorder (GAD). In addition to GAD, ulotaront is being investigated in late-stage clinical studies for the treatment of schizophrenia and for the adjunctive treatment of major depressive disorder (MDD).

“Generalized anxiety disorder is a chronic condition characterized by excessive anxiety or worries, sleep disturbances, changes in appetite and impairment of social and occupational activities which can have a profound impact on nearly all aspects of an individual’s life,” said Armin Szegedi, M.D., Ph.D., Senior Vice President, Chief Medical Officer at Sunovion. “Preliminary data from preclinical and clinical studies of ulotaront suggest an anxiety-reducing effect, which we aim to understand further in patients with GAD. We believe that ulotaront is a potentially important novel mechanism and therapeutic advance for the treatment of GAD and other serious mental health conditions.”

The multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study will evaluate ulotaront’s efficacy and safety in people living with GAD. A total of 434 patients are expected to be randomized into two treatment groups, receiving either ulotaront (SEP-363856, 50–75 mg/day) or placebo in a 1:1 ratio for eight weeks. The primary endpoint is reduced anxiety symptoms, as measured by a change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score, compared to placebo at Week 8.

“With the expansion of ulotaront’s clinical development program to a third indication, we are making significant progress towards goals we set for co-development and co-commercialization with Sunovion to address areas of high unmet need for people living with serious mental illnesses,” said John Kraus, M.D., Ph.D., Executive Vice President and Chief Medical Officer at Otsuka. “We believe that ulotaront has the potential to help those living with GAD safely and effectively manage their symptoms and we look forward to advancing the understanding of this innovative compound.”