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Intra-Cellular Therapies' Candidate Fails in Phase III Study

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Intra-Cellular Therapies, Inc. (ITCI - Free Report) announced data from two phase III studies — Study 401 and Study 404 — evaluating its lead candidate, lumateperone, as monotherapy for treating patients major depressive episodes associated with bipolar I or bipolar II disorder.

Shares of Intra-Cellular Therapies fell 13.1% on Jul 8 as its lead candidate, lumateperone, failed to meet the primary endpoint in Study 401. The company’s shares are up 2.7% so far this year compared with the industry’s increase of 3.9%.


Study 401 evaluated two doses of lumateperone — 42mg and 28mg — in the patient population. The candidate failed to meet the primary endpoint of statistical separation from placebo in improving depression as measured by change from baseline on the Montgomery-Åsberg Depression Rating Scale (“MADRS”) total score. Mean reduction from baseline for the higher and lower dose of lumateperone was 20.7 points and 18.9 points, respectively, compared 19.7 points for placebo.

However, the candidate met the primary endpoint of statistically significant greater improvement over placebo at week 6, measured on MADRS scale, in Study 404. The study evaluated single dose of 42mg of the candidate in the patient population. The mean reduction from baseline was 16.7 points versus 12.1 points for placebo.

Lumateperone demonstrated favorable safety and tolerability profile in both the late-stage studies.

Please note that the company had filed a new drug application (“NDA”) for lumateperone last year, seeking approval as a treatment for schizophrenia. A decision from the FDA is expected in September. Last month, the company had informed that the FDA will hold an advisory committee meeting on Jul 31 to discuss the NDA.

Notably, the bipolar depression market is highly competitive as multiple companies are trying to introduce treatments for the disease. In March, Allergan’s (AGN - Free Report) schizophrenia drug, Vraylar, received approval for label expansion to include bipolar depression. Other players in the bipolar disorder and schizophrenia treatment market include AstraZeneca plc's (AZN - Free Report) Seroquel XR, Johnson & Johnson's (JNJ - Free Report) Risperdal Consta and Alkermes plc's Aristada.

Intra-Cellular Therapies is also developing lumateperone in early-to mid-stage studies as a treatment for other central nervous system disorder including dementia. The company also has another clinical stage candidate, ITI-214, which is being developed for multiple indications including Parkinson’s disease.

Zacks Rank

Intra-Cellular Therapies currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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