Intra-Cellular initiates second late-stage study of lead product candidate

• Intra-Cellular Therapies (ITCI +3.7%) initiates enrollment in a second Phase 3 trial (ITI-007-302) assessing its lead product candidate, ITI-007, in patients with an acutely exacerbated episode of schizophrenia. The treatment period is six weeks. The primary endpoint is the change from baseline at Day 42 in the PANSS total score (Positive And Negative Syndrome Scale). Top-line results are expected in 2016.
• Enrollment in the first Phase 3, ITI-007-301, was completed earlier this month. Top-line data are expected in H2.
• In low doses, ITI-007 acts as a 5-HT2A serotonin receptor antagonist. At higher doses, it also modulates dopamine receptors and inhibits serotonin transporters.