Benzinga | Dec 29, 2020 08:07AM EST

Intra-Cellular Therapies Announces Initiation Of Clinical Trials For ITI-LLAI Long-Acting Injectable Formulation Of Lumateperone For Treatment Of Schizophrenia And ITI-333, A Novel Treatment For Opioid Use Disorder

The Company continues expansion of its lumateperone programs with the advancement of a Long-Acting injectable formulation into clinical trials.



ITI-333 introduces a unique pharmacology for the treatment of opioid use disorder.

NEW YORK, Dec. 29, 2020 (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 initiation of clinical programs for the Company's lumateperone long-acting injectable formulation (ITI-LLAI) and for ITI-333, a novel molecule for the treatment of opioid use disorder.

"I am pleased to announce that two important proprietary programs have advanced into human clinical testing, further demonstrating our commitment to patients through the development of novel treatments for schizophrenia, mood disorders and other neuropsychiatric and neurologic disorders," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.

LLAI, Study ITI-007-025: A Phase 1 single ascending dose study of LLAI, a formulation designed to be administered subcutaneously and to maintain therapeutic levels of lumateperone for at least 1 month. This study will evaluate the pharmacokinetics, safety and tolerability of lumateperone LAI in patients with stable symptoms of schizophrenia. Results from this study will inform the dosing strategy for future studies.

Maintaining patients symptomatically stable and functional are the primary objectives of the treatment of schizophrenia. Long-acting injectable antipsychotics provide patients with blood concentrations of active drug that remain within a therapeutic range for an extended period. These formulations represent a treatment option for patients who prefer not to take medication daily or have history of poor adherence to oral treatments as they have the potential to improve adherence and prevent relapse. Oral lumateperone has demonstrated efficacy in treating schizophrenia symptoms with a favorable safety and tolerability profile. A long-acting formulation of lumateperone if successfully developed and approved will provide an additional option for patients.

ITI-333, Study ITI-333-001: A Phase 1 single ascending dose study evaluating the safety, tolerability and pharmacokinetics of ITI-333 in healthy volunteers. ITI333 is a novel compound that uniquely combines activity as an antagonist at serotonin 5-HT2A receptors and a partial agonist at ?-opioid receptors. These combined actions support the potential utility of ITI-333 in the treatment of opioid use disorder and associated comorbidities (e.g., depression, anxiety, sleep disorders) without opioid-like safety and tolerability concerns.

Opioid use disorder is a chronic disorder with over 10 million people in the United States having misused opioids and nearly fifty-thousand persons died from opioid drug overdoses in 2018.