Intra-Cellular Therapies (NASDAQ:ITCI) slips 9% premarket on increased volume on the heels of its announcement of results from two Phase 3 clinical trials evaluating lumateperone in patients with bipolar depression.
Study 404 met the primary endpoint of a statistically significant change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p<0.001). Key secondary endpoints were also met.
Study 401, however, failed to achieve the primary endpoint due to an unexpectedly high response rate in the placebo arm. Specifically, patients receiving the 42 mg dose or the 28 mg dose of lumateperone showed least squares (LS) mean reductions from baseline in MADRS score of 20.7 points and 18.9 points compared to 19.7 points for control.
No new safety signals were observed.
Additional results will be released in the near future.
Management will host a conference call this morning at 8:00 am ET to discuss the results.
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