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Intra-Cellular Therapies Discloses New Drug Candidate For Dementia Related Episodes

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Vandana Singh
·1 min read
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  • Intra-Cellular Therapies Inc (NASDAQ: ITCIexpands its pipeline with a new molecular entity, ITI-1284, a sublingually delivered deuterated form of lumateperone.

  • ITI-1284 has been developed in collaboration with Catalent Inc (NYSE: CTLT), using its proprietary Zydis ODT (orally disintegrating tablet) fast-dissolving formulation.

  • The company completed Phase 1 studies that showed ITI-1284 ODT-SL was rapidly absorbed into the systemic circulation, was metabolically stable, and resulted in high systemic exposure.

  • No serious adverse events were reported. In the elderly cohort, reported adverse events were infrequent, with the most being transient dry mouth (mild).

  • Intra-Cellular plans to develop ITI-1284 ODT-SL to treat behavioral disturbances in patients with dementia-related psychosis and certain depressive disorders in the elderly.

  • Yesterday, the company filed a supplemental marketing application for CAPLYTA (lumateperone) to the FDA for depressive episodes associated with bipolar I or II disorder in adults.

  • Price Action: ITCI shares are up 1.76% at $37.54 on the last check Wednesday.

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