FDA advisory committee to meet July 31 to review lumateperone / ITI-007

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NEW YORK, June 13, 2019 (GLOBE NEWSWIRE) – Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has announced a Psychopharmacologic Drugs Advisory Committee meeting to be held on July 31, 2019 to discuss the New Drug Application (NDA) for lumateperone with the proposed indication of treatment of schizophrenia in adults. Lumateperone is a novel investigational drug with an NDA currently under review by FDA as a treatment of schizophrenia in adults.

FDA’s expected Prescription Drug User Fee Act (PDUFA) action date is September 27, 2019.

“There remains a significant unmet medical need in the treatment of schizophrenia,” said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. “We welcome the opportunity to present our data at the Advisory Committee meeting as we continue working to bring lumateperone to patients living with this debilitating disease.”

About Lumateperone for the Treatment of Schizophrenia

Lumateperone, our lead product candidate, is a molecule that provides selective and simultaneous modulation of serotonin, dopamine, and glutamate - three neurotransmitter pathways implicated in severe mental illness. Lumateperone is a potent serotonin 5-HT2A receptor antagonist, a dopamine receptor phosphoprotein modulator (DPPM) acting as a presynaptic partial agonist and postsynaptic antagonist at dopamine D2 receptors, a dopamine D1 receptor-dependent indirect modulator of glutamate (both NDMA and AMPA), and a serotonin reuptake inhibitor. This compound is being investigated in patients suffering from a range of neuropsychiatric and neurodegenerative diseases.

Company press release regarding FDA meeting

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In other lumateperone news, phase 3 results for Bipolar Depression are expected the week of July 8-12.

“ITCI has a number of binary events ahead this quarter, some of which are only about a week away. In week of July 8, there are top-line results for 2 phase 3 trials in bipolar depression (BPD) (one U.S. only and one international). We feel that there is a lot of uncertainty in these readouts for the following reasons: First, although there is some data on depression-related readouts in some ITI-007 schizophrenia trials (see e.g. CDSS scores in Table 2 of the Phase 2 trial publication), there is no prior BPD data for ITI-007, which is unusual for a molecule in a phase 3 trial; Second, ITI-007 has a very complex mechanism of action that to us makes it more unpredictable in an indication where there has been no prior human clinical data for this therapeutic candidate; and third, we are concerned regarding a high placebo effect, which has been difficult to control in CNS trials and which ITCI saw rear its head in a prior ITI-007 phase 3 trial (See Study ITI-007 failed Study 3 press release), albeit in schizophrenia and not BPD.”

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is there info about when will marketed

is this approval date?

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The FDA decision to approve or reject lumateperone has to be made September 27 or sooner.

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