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Otsuka and Sunovion Initiate Clinical Development of Ulotaront for the Adjunctive Treatment of Major Depressive Disorder

Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Sunovion Pharmaceuticals Inc. (Sunovion) announced that the first patient has been enrolled in a Phase 2/3 clinical study to evaluate ulotaront (SEP-363856), a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity, as an adjunctive therapy in the treatment of adults living with major depressive disorder (MDD). Ulotaront, which is also being evaluated in Phase 3 clinical development for the treatment of schizophrenia, is the first TAAR1 agonist to be studied as an adjunctive therapy in the treatment of MDD.

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“Even with available approaches, many patients do not achieve optimal responses to treatment, in part due to the heterogeneous nature of the condition, highlighting the need for new and different treatment modalities.”

The global, multicenter, randomized, double-blind, placebo-controlled study is designed to examine the efficacy, safety and tolerability of ulotaront as an adjunctive therapy in the treatment of adults with MDD. Patients with an inadequate response to current antidepressant treatment will be randomized to receive ulotaront or placebo in addition to their antidepressant therapy.

The primary endpoint for the study is the reduction of depressive symptoms, as measured by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score, compared to placebo at the end of the study.

“MDD is a disabling mental health condition that often requires a combination of first-line antidepressant medication and adjunctive treatments to alleviate symptoms,” said John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka. “Even with available approaches, many patients do not achieve optimal responses to treatment, in part due to the heterogeneous nature of the condition, highlighting the need for new and different treatment modalities.”

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Depressive disorders, including MDD, affect roughly 280 million people worldwide.1 MDD is anticipated to rank first in global burden of disease by 2030.2

“The initiation of the Phase 2/3 study evaluating the use of ulotaront as an adjunctive treatment of major depressive disorder is an important step towards exploring the full medical potential of this novel TAAR1 agonist,” said Armin Szegedi, M.D., Ph.D., senior vice president, chief medical officer at Sunovion. “We have been encouraged by the pre-clinical data showing that ulotaront could have benefits for those living with mood disorder and look forward to enhancing the understanding of this innovative compound in collaboration with Otsuka.”

About Ulotaront (SEP-363856)
Ulotaront, a TAAR1 agonist with 5-HT1A agonist activity, is currently under investigation for the treatment of schizophrenia as well as the adjunctive treatment of MDD, with additional indications under consideration.

Ulotaront was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in 2019. Ulotaront is the first TAAR1 agonist to enter into Phase 3 clinical studies in adults and adolescents (13 to 17 years) with schizophrenia. It’s also the first TAAR1 agonist to enter into a Phase 2/3 clinical study as an adjunctive therapy for MDD.

Ulotaront is being jointly developed and commercialized as part of a collaboration between Otsuka Pharmaceutical Co., Ltd, Sunovion, and its parent company Sumitomo Pharma Co., Ltd. Sunovion discovered ulotaront in collaboration with PsychoGenics based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube® platform and associated artificial intelligence algorithms.

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