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

Intra-Cellular Therapies Inc (NASDAQ: ITCI) expands 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.