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Tuesday, Intra-Cellular Therapies Inc (NASDAQ:ITCI) released topline results from Study 502 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).
The company expects to submit a supplemental FDA application in the second half of 2024.
Lumateperone 42 mg, given once daily as adjunctive therapy to antidepressants, met the primary endpoint in Study 502 by demonstrating a statistically significant and clinically meaningful reduction in the Montgomery and Asberg Depression Rating Scale (MADRS) total score compared to placebo at Week 6.
MADRS evaluates depression severity.
Related: Intra-Cellular Stock Rallies On Successful Late-Stage Depression Treatment Study.
In the modified intent-to-treat (mITT) study population, the least squares (LS) mean reduction from baseline for lumateperone 42 mg was 14.7 points, versus 10.2 points for placebo (LS mean difference = -4.5 points; p<0.0001; ES= 0.56).
Numerical improvement versus placebo on the MADRS total score was seen as early as Week 1 (p=0.0504) and statistically significant separation starting at Week 2 and maintained throughout the study.
Lumateperone 42 mg also met the key secondary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the CGI-S score (severity of illness) compared to placebo at Week 6 (p<0.0001; ES= 0.51).
Statistically significant separation on the CGI-S versus placebo was observed starting at Week 3 and maintained throughout the study.
In this study, lumateperone 42 mg robustly improved depressive symptoms.
Lumateperone was generally safe and well-tolerated in this study.
In the pooled safety data of Studies 501 and 502, the most common adverse events with lumateperone versus placebo were dizziness, dry mouth, somnolence, nausea, and fatigue.
Price Action: ITCI shares are up 10.5% at $76.10 at last check Tuesday.
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Posted In: ITCI
