Intra-Cellular Therapies highlights lumateperone presentations on bipolar depression at the 58th annual meeting of the American College of Neuropsychopharmacology.

Intra-Cellular Therapies, Inc. announced data featured during the 58th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) held in Orlando, FL, December 8-11, 2019 included: �Lumateperone (ITI-007) in the Treatment of Bipolar Depression: Results from a Randomized Clinical Trial� (Poster W123): This poster presented data from the positive Phase III clinical trial of lumateperone for the treatment of patients with bipolar depression (ITI-007-404 or Study �404). Study 404 was conducted globally, including in the U.S., and included 381 patients randomized (1:1) to receive lumateperone 42 mg or placebo once daily for six weeks. Lumateperone met its primary endpoint of change from baseline at Week 6 on the Montgomery-�sberg Depression Rating Scale (MADRS) total score versus placebo (p<0.0001; effect size es="0.56)." in the intent-to-treat study population the ls mean improvement from baseline for lumateperone 42 mg was 16.7 points versus 12.1 points for placebo for a 4.6-point difference between the two groups. lumateperone also met the studys key secondary endpoint clinical global impression scale for bipolar for severity of illness cgi-bp-s total score p><0.001; es="0.46)." in addition the cgi component that specifically assesses depression showed improvement with lumateperone versus placebo cgi-bp-s depression score p><0.001; es="0.50)." this improvement was statistically significant as early as week 1 the first time point measured and was maintained at every time point throughout the study.>

In subgroup analyses of both Bipolar I patients and Bipolar II patients, statistically significant improvements were seen versus placebo on the MADRS total score (Bipolar I patients: p<.0001; es: 0.49 and bipolar ii patients: p><.001; es: 0.81. these results were supported by statistically significant improvements on responder rates and remission rates demonstrating the clinical meaningfulness of the primary outcome with 51.1 of patients on lumateperone meeting madrs response criteria 50 improvement from baseline versus 36.7 for placebo at day 43 p><0.001). additionally 39.9 of patients on lumateperone were considered remitters madrs 12 versus 33.5 for placebo p=""><0.05). the safety profile in this study was consistent with previously reported placebo-controlled and open-label studies in patients with schizophrenia. lumateperone showed similar effects as placebo on assessments of body weight metabolic parameters extrapyramidal symptoms and prolactin. rates of akathisia restlessness and extrapyramidal symptoms combined were less than 1 and similar to placebo. the most commonly reported adverse events that were observed at a rate greater than 5 and higher than placebo were somnolence 8.5 and nausea 6.4. the rates of discontinuation due to treatment emergent adverse events for lumateperone were less than 5 percent.>

About Lumateperone Bipolar Depression Program : The lumateperone clinical trial program in bipolar depression includes three Phase III trials. Two trials, Study 401 and Study 404, evaluated lumateperone as monotherapy and the third trial, Study 402, is evaluating lumateperone as an adjunctive therapy to lithium or valproate. The safety and efficacy of lumateperone in bipolar disorder has not been established.