long-acting lumateperone (ITI-007 LAI) / J&J - LARVOL DELTA

Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder (clinicaltrials.gov) - P1 | N=52 | Completed | Sponsor: Intra-Cellular Therapies, Inc. | Recruiting ➔ Completed | Trial completion date: Mar 2026 ➔ Nov 2025

Trial completion • Trial completion date • CNS Disorders • Psychiatry • Schizophrenia

Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc.

New P1 trial • CNS Disorders • Psychiatry • Schizophrenia

Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia (clinicaltrials.gov) - P1 | N=37 | Completed | Sponsor: Intra-Cellular Therapies, Inc. | Recruiting ➔ Completed

Trial completion • CNS Disorders • Psychiatry • Schizophrenia

Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Intra-Cellular Therapies, Inc. | N=24 ➔ 32 | Trial completion date: Dec 2021 ➔ Jun 2022 | Trial primary completion date: Nov 2021 ➔ Jun 2022

Enrollment change • Trial completion date • Trial primary completion date • CNS Disorders • Psychiatry • Schizophrenia

Intra-Cellular Therapies Reports Third Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - “Lumateperone: Study 403 is ongoing and is evaluating lumateperone 42mg in patients with MDD and in patients with bipolar depression...We expect to complete this study in the second half of 2022; Study ITI-007-025, a Phase 1 single ascending dose study of LLAI, is ongoing. We expect to complete this study later this year….ITI-1284 program: We have initiated our program for the development of ITI-1284-ODT-SL for the treatment of agitation in patients with probable Alzheimer’s disease. Clinical conduct in this program is expected to commence early in 2022. Studies in dementia-related psychosis and certain depressive disorders in the elderly are planned for the first half of 2022. Phosphodiesterase type I inhibitor (PDE1) program: Our Phase 2 clinical program evaluating lenrispodun (ITI-214) in Parkinson’s disease has been initiated, and we expect to commence patient enrollment in the first half of 2022.”

New P2 trial • New trial • Trial completion date • Alzheimer's Disease • Bipolar Disorder • CNS Disorders • Depression • Major Depressive Disorder • Parkinson's Disease • Schizophrenia

Intra-Cellular Therapies Reports Second Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "Total revenues were $20.0 million for the second quarter of 2021, compared to $1.9 million of total revenues for the second quarter of 2020. Net product revenues of CAPLYTA were $19.0 million for the second quarter of 2021, compared to $1.9 million in net product revenues of CAPLYTA for the same period in 2020. Net product revenues of CAPLYTA increased 22% from $15.6 million in the prior quarter....CAPLYTA market access coverage is strong with greater than 95% of covered lives in both Medicare Part D and State Medicaid, the major payer channels in schizophrenia....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 one month, is ongoing. Initial results from this study are anticipated in the second half of 2021."

P1 data • Reimbursement • Sales • CNS Disorders • Schizophrenia

Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Intra-Cellular Therapies, Inc.

Clinical • New P1 trial • CNS Disorders • Psychiatry • Schizophrenia

Intra-Cellular Therapies Announces the Initiation of Clinical Trials for ITI-LLAI, a Long-Acting Injectable Formulation of Lumateperone for the Treatment of Schizophrenia and for ITI-333, a Novel Treatment for Opioid Use Disorder (GlobeNewswire) - "Intra-Cellular Therapies, Inc....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....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."

Trial status • CNS Disorders • Schizophrenia

Intra-Cellular Therapies Reports Third Quarter 2020 Financial Results and Provides Corporate Update (GlobeNewswire) - "Third quarter CAPLYTA results reflect strong commercial execution delivering continued robust week-over-week and quarter-over-quarter prescription growth; third quarter total prescriptions increased by approximately 280% versus the previous quarter....CAPLYTA’s market access continues to be strong with greater than 95% of covered lives in both Medicare Part D and State Medicaid, the major payer channels in schizophrenia. Our LytaLink program continues to support eligible patients’ access pathway for CAPLYTA....We recently completed a successful Type C meeting with the FDA. We plan to initiate clinical testing of our lumateperone long-acting injectable program later this year. An ascending single dose safety and pharmacokinetic (PK) study will be conducted followed by a multiple ascending dose safety and PK study administered subcutaneously."

Commercial • New trial • Reimbursement • CNS Disorders • Schizophrenia

Intra-Cellular Therapies reports fourth quarter and full-year 2019 financial results and provides corporate update (GlobeNewswire) - "Our preparations for the commercial launch of CAPLYTA later this month are fully on track...At the time of launch, CAPLYTA will be priced in line with other currently marketed branded antipsychotics indicated for the treatment of schizophrenia....Efficacy of CAPLYTA 42 mg was demonstrated in two placebo-controlled trials, showing a statistically significant benefit over placebo on the primary endpoint....The most common adverse reactions (≥5% and twice the rate of placebo) for the recommended dose of CAPLYTA vs. placebo were somnolence/sedation (24% vs.10%) and dry mouth (6% vs. 2%)...Within the lumateperone portfolio, we are also developing a long-acting injectable formulation to provide more treatment options to patients suffering from schizophrenia. We have completed the preclinical development of an LAI formulation and plan to initiate a Phase 1 clinical trial in 2020."

Launch US • New P1 trial • Retrospective data