ARTICLE | Clinical News

Intra-Cellular sinks on Phase III schizophrenia miss

September 28, 2016 7:00 AM UTC

Intra-Cellular Therapies Inc. (NASDAQ:ITCI) fell $28.60 (68%) to $13.75 in early after-hours trading after it said neither of two doses of ITI-007 "separated from placebo" on the primary endpoint of a Phase III trial to treat schizophrenia. The company said an unusually high placebo response contributed to the miss.

From baseline to six weeks, 60 mg daily ITI-007 lowered Positive and Negative Syndrome Scale (PANSS) total scores by 15.0 points, while a 20 mg dose lowered scores by 14.6 points. Scores fell by 15.1 points in the placebo group, and by 20.5 points in an active control cohort receiving 4 mg risperidone daily. The separation was significant for risperidone vs. placebo. ...