Intra-Cellular Therapies, Inc. (ITCI) reported positive topline results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder. In the study, Lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints. Also, Lumateperone was generally safe and well-tolerated in the study.
Suresh Durgam, Executive Vice President, Chief Medical Officer of Intra-Cellular Therapies, said: "In this Phase 3 study, lumateperone demonstrated a robust effect as an adjunctive treatment to antidepressants in patients with MDD who had inadequate response to antidepressant therapy. This study contributes to the growing body of evidence of lumateperone's efficacy and safety across mood disorders."
Topline results from second Phase 3 study, Study 502, are expected late in the second quarter of current year.
Shares of Intra-Cellular Therapies are up 20% in pre-market trade on Tuesday.
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