Intra-Cellular Therapies Inc. is optimistic that mixed Phase III results for its novel atypical antipsychotic lumateperone in bipolar depression could be sufficient for approval, especially since the drug demonstrated efficacy in patients with bipolar II disorder, an underserved subpopulation. The candidate met its primary endpoint for improvement in depressive episodes in one Phase III monotherapy study, but did not separate from placebo in a second monotherapy trial.
Lumateperone offers a novel mechanism of action for neuropsychiatric indications as a selective and simultaneous modulator of serotonin, dopamine and...