Kenneth Koblan, PhD: SEP-4199 Showing Promise Treating Bipolar Depression

Stakeholders are touting positive results from a new study testing a new treatment for bipolar depression.

Earlier this month, Sunovion announced topline results of the global SEP-4199 phase 2 study show patients with bipolar I depression treated with SEP-4199 experienced clinically meaningful improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) total score compared to placebo after 6 weeks of treatment.

SEP-4199, a non-racemic ratio of amisulpride enantiomers with increased potency for serotonin 5-HT₇ receptors relative to dopamine D2 receptors, was effective treating patients with bipolar I depression.

The treatment showed numerical improvement in the MADRS total score compared to placebo after 6 weeks of treatment (200 mg, -19.5 vs -16.2; 400 mg, -19.3 vs -16.2 respectively, both dose groups vs placebo, P = 0.054; 200 mg group effect size (ES), -0.31 and 400 mg group ES, -0.29).

There were very few adverse events reported in the trial with QT prolongation (observed in the 400 mg arm), somnolence, constipation, galactorrhea, nausea, akathisia, dizziness, hypomania and diarrhea reported in at least 2% of patients.

A serious adverse event was also reported in 1 patient.

In an interview with HCPLive®, Kenneth Koblan, PhD, Chief Scientific Officer of Sunovion, explained how effective the drug could be and how difficult it is to treat patients with bipolar depression.