Benzinga | Feb 24, 2021 07:40AM EST

Intra-Cellular Therapies Announces Addition Of ITI-1284 To Its Pipeline

ITI-1284 is a deuterated form of lumateperone delivered sublingually as an orally disintegrating tablet (ODT-SL). ITI-1284 ODT-SL may offer pharmacologic benefits and ease-of-use for patients, particularly in elderly populations.



Phase 1 single ascending dose and multiple ascending dose studies have been completed in healthy volunteers including elderly subjects > than 65 years of age.

Company plans to develop ITI-1284 for the treatment of behavioral disturbances in dementia, dementia-related psychosis, and certain depressive disorders in the elderly.

NEW YORK, Feb. 24, 2021 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the expansion of its pipeline with ITI-1284 ODT-SL. ITI-1284 is a deuterated form of lumateperone, a new molecular entity formulated as an oral disintegrating tablet for sublingual administration. Following recent completion of its Phase 1 program, the Company plans to develop ITI-1284 ODT-SL for the treatment of behavioral disturbances in patients with dementia, the treatment of dementia-related psychosis and the treatment of certain depressive disorders in the elderly.

ITI-1284 ODT-SL is formulated as an oral solid dosage form that dissolves almost instantly when placed under the tongue, allowing for ease of use in the elderly and may be particularly beneficial for patients who have difficulty swallowing conventional tablets. ITI-1284 ODT-SL has been developed in collaboration with Catalent using its proprietary Zydis(r) ODT (orally disintegrating tablet) fast-dissolving formulation.

Our recently completed Phase I program found that ITI-1284 ODT-SL was rapidly absorbed into the systemic circulation, was metabolically stable, and resulted in high systemic exposure. Our Phase 1 single and multiple ascending dose studies in healthy volunteers and healthy elderly volunteers (> than 65 years of age) evaluated the safety, tolerability and pharmacokinetics of ITI-1284. In these studies, there were no reported serious adverse events in either age group. In the elderly cohort, reported adverse events were infrequent with the most common adverse event being transient dry mouth (mild).

Based on these studies, the Company plans to initiate Phase 2 studies evaluating ITI-1284 ODT-SL for the treatment of behavioral disturbances in dementia, dementia-related psychosis, and certain depressive disorders in the elderly.