Benzinga - by Vandana Singh, Benzinga Editor.
Intra-Cellular Therapies Inc (NASDAQ:ITCI) unveiled on Tuesday topline results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).
Topline results from the second Phase 3 study, Study 502, are anticipated late in the second quarter of this year.
Caplyta (lumateperone) is a once-daily pill proven to deliver significant symptom relief from bipolar I and bipolar II depression.
“We believe that these robust efficacy results coupled with its favorable safety and tolerability profile and convenient dosing make CAPLYTA a compelling option as an adjunctive treatment for MDD, if approved,” said Sharon Mates, chairman and CEO of Intra-Cellular Therapies.
Lumateperone 42 mg, given once daily as adjunctive therapy to antidepressants, met the primary endpoint in Study 501 by demonstrating a statistically significant and clinically meaningful reduction in the MADRS total score compared to placebo at Week 6.
Montgomery–Åsberg Depression Rating Scale (MADRS) is a widely used clinician‐rated measure of depressive severity.
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 9.8 points for placebo, with an effect size of 0.61.
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, with an effect size of 0.67.
Statistically significant efficacy was seen at the earliest time point tested (Week 1) and maintained throughout the study in the primary and the key secondary endpoints.
In this study, lumateperone 42 mg robustly improved depressive symptoms, as reported by patients.
Lumateperone was generally safe and well-tolerated in this study.
ITCI Price Action: Intra-Cellular Therapies shares are up 27.60% at $82.64 at publication Tuesday.
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