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July 8, 2019, 7:15 a.m. EDT

Intra-Cellular announces positive results in late-stage trials of treatment for bipolar depression

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By Ciara Linnane


Intra-Cellular Therapies Inc. on Monday reported positive results from two late-stage trials of a treatment for bipolar depression. The New York-based company said the two phase 3 trials of lumateperone met their primary endpoints. In Study 404, that goal was change from baseline at week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo. Study 404 also met its key secondary endpoint, on the Clinical Global Impression Scale for Bipolar for Severity of Illness, or CGI-BP-S. That study produced positive results for patients with Bipolar type I and Bipolar type 2. "In Study 401, lumateperone did not separate from placebo," the company said in a statement. "A high placebo response was observed in the trial." Study 404 was conducted globally, including in the U.S. and included 381 patients. Study 401 was conducted only in the U.S. and involved 554 patients. "Consistent with previous studies in schizophrenia, lumateperone was well-tolerated in both bipolar depression studies, with a favorable safety profile," said the statement. Shares were halted for the news, but have gained 18.2% in 2019, while the S&P 500 /zigman2/quotes/210599714/realtime SPX +0.11% has gained 19.3%.

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