Sunovion Pharmaceuticals and Otsuka Pharmaceutical Development & Commercialization (Otsuka) have announced the randomisation of the first patient in a Phase II/III clinical trial of ulotaront to treat generalised anxiety disorder (GAD).

Ulotaront, a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity, is being evaluated for its safety and efficacy.

The double-blind, multicentre, parallel-group, randomised, flexible-dose, placebo-controlled study expects to enrol a total of 434 patients.

Two treatment groups will either receive ulotaront (SEP-363856, 50–75 mg/day) or placebo in a 1:1 fashion for eight weeks.

The primary endpoint of the study is reduced anxiety symptoms, as measured by a change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score, against placebo at week eight.

Sunovion senior vice-president and chief medical officer Armin Szegedi said: “Generalised anxiety disorder is a chronic condition characterised 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.

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“Preliminary data from preclinical and clinical studies of ulotaront suggest an anxiety-reducing effect, which we aim to understand further in patients with GAD.”

In addition to GAD, ulotaront is currently being investigated for schizophrenia and as an adjunctive treatment for major depressive disorder.

Otsuka executive vice-president and chief medical officer John Kraus said: “With the expansion of ulotaront’s clinical development programme to a third indication, we are making significant progress towards goals we set for co-development and co-commercialisation with Sunovion to address areas of high unmet need for people living with serious mental illnesses.”

Otsuka with Sunovion, and the latter’s parent company Sumitomo Pharma, are together developing and commercialising ulotaront as part of a collaboration agreement.