Sunovion Pharmaceuticals presented data on two investigational compounds at the recent 59th Annual Meeting of the American College of Neuropsychopharmacology—SEP-363856, which is being studied for the treatment of schizophrenia, and SEP-4199, which is being evaluated as a treatment of major depressive episodes in bipolar I disorder.
One poster featured secondary endpoint data from a double-blind 4-week study and subsequent 6-month open label extension study of SEP-363856, which is a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A agonist activity.
Sunovion has previously reported that patients in the 4-week study demonstrated significant improvement on the Brief Negative Symptom Scale (BNSS) total score and other assessments of negative symptoms of schizophrenia, and the US FDA granted Breakthrough Therapy Designation for SEP-363856 for schizophrenia in May 2019.
Additional analysis found that patients also saw improvements in BNSS factor scores including blunted affect, asociality, and avolition, according to a press release from the company. (ES, 0.42). Patients continued to experience improvements in negative symptoms throughout the subsequent 6-month trial.
Novel Antipsychotic Outperforms Placebo in Easing Schizophrenia Symptoms
Another poster presented data on the efficacy, safety, and tolerability of SEP-4199, which is a non-racemic ratio of amisulpride enantiomers (85% aramisulpride to 15% esamisulpride). In a randomized, double-blind, placebo-controlled study, patients taking either 200 mg or 400 mg of the compound showed more improvement than placebo groups in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score after 6 weeks of treatment.
In the full intent-to-treat (ITT) analysis, improvements were also observed, compared with placebo, on the Quick Inventory of Depressive Symptomatology (Self-Report) for both doses.
“SEP-363856 and SEP-4199 represent innovative approaches to the way serious mental health conditions like schizophrenia and bipolar depression may be treated in the future,” said Sunovion senior vice president and chief medical officer Armin Szegedi, MD, PhD.
“While our industry has made great strides in the development of therapies to address these conditions, there remains an unmet need to develop medicines that may manage multiple aspects of these disorders while minimizing potential side effects.”
Sunovion highlights data from its late-stage psychiatric medicine pipeline at the American College of Neuropsychopharmacology (ACNP) Annual Meeting 2020 [press release]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; December 10, 2020.