Late-Stage Pipeline Candidate Looks Promising for the Treatment of Schizophrenia


Data presented at the 2021 APA Virtual Annual Meeting show promise for treating schizophrenia.

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Sunovion Pharmaceuticals presented data on the late-stage pipeline candidate SEP-363856, a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A agonist activity under investigation for the treatment of schizophrenia at the 2021 American Psychiatric Association Virtual Annual Meeting.

“The SEP-363856 safety analysis presented at APA supports previous clinical trial evidence that this agent is associated with a differentiated side effect profile compared to currently approved atypical antipsychotics. These data further support the characterization of SEP-363856 as representing a new class of medicines for the treatment of schizophrenia,” Armin Szegedi, MD, PhD, Senior Vice President and Chief Medical Officer of Sunovion, said to the press. “We are pleased to discuss these SEP-363856 data with the clinical community to foster further understanding of this novel compound.”1

SEP-363856 was highlighted in the poster titled “The Safety Profile of the TAAR1 Agonist, SEP-363856, is Distinct From Atypical Antipsychotics,” (poster P12-007). The poster covered data analysis from the US Food and Drug Administration’s (FDA) real-world adverse event reporting database (FAERS), and compared the frequency of adverse events (AEs) related to antipsychotic schizophrenia treatment occurring in 11 atypical antipsychotics to those in observed with SEP-363856 in clinical studies.

The analysis found the cumulative rate and patterns of AEs was distinctly different for SEP-363856 than for atypical antipsychotics.

The presentation “Effects of SEP-363856, a Novel TAAR1 Agonist, on Negative Symptoms in Schizophrenia: Results Across an Initial Double-Blind Acute Study and a 6-Month, Open-Label Extension Study,” (poster P11-086), also highlighted the pipeline candidate. It demonstrated that short-term treatment with SEP-363856 saw improvement in negative symptoms of schizophrenia when compared to placebo. Long-term treatment also saw additional mean improvement in the Brief Negative Symptom Scale (BNSS) total score and BNSS factor scores.


1. Sunovion. Sunovion presents data from marketed and late-stage development psychiatric compounds at the American Psychiatric Association (APA) Annual Meeting 2021. News release. May 3, 2021.

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