Benzinga | Feb 24, 2021 10:42AM EST

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.