Intra-Cellular Therapies Inc. (NASDAQ: ITCI) shares dipped on Monday after the company announced top-line results from its two late-stage trial in patients with bipolar depression. Specifically, the data came from the two Phase 3 trials (Study 401 and Study 404) of lumateperone.
Ultimately, Study 404 met its primary endpoint of improvement in depression as measured by change from baseline versus placebo on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
The study met its key secondary objective on the Clinical Global Impression Scale for Bipolar for Severity of Illness total score. Lumateperone also was positive on the CGI component that specifically assesses depression.
On the other hand, Study 401 did not meet its primary endpoint of statistical separation from placebo as measured by change from baseline on the MADRS total score. Overall, a high placebo response was observed in the trial.
Dr. Sharon Mates, board chair and chief executive of Intra-Cellular, commented:
We consider today’s positive results to be a significant milestone in our bipolar depression program. The distinct pharmacological profile of lumateperone and positive clinical results in schizophrenia and bipolar depression further support the potential for benefits in a broad range of neuropsychiatric conditions, including major depressive disorder. It is an exciting time at ITCI as we prepare for the launch of lumateperone for the treatment of schizophrenia, pending FDA approval.
Shares of Intra-Cellular closed Friday at $13.46, in a 52-week range of $10.21 to $23.62. The consensus analyst price target is $29.50. Following the announcement, the stock was down about 15% at $11.45 in early trading indications Monday.