ITCI Intra-Cellular Therapies Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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Lumateperone ITI-007-402
Bipolar depression
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sNDA Filing
sNDA Filing
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Lumateperone ITI-007-403
Bipolar Depression
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Phase 3
Phase 3
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Phase 3 trial ongoing.
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ITI-LLAI (ITI-007-025)
Schizophrenia
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Phase 1
Phase 1
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Phase 1 trial initiation announced December 29, 2020.
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ITI-333 (ITI-333-001)
Opioid use disorder
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Phase 1
Phase 1
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Phase 1 trial initiation announced December 29, 2020.
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ITI-214-105
Heart failure
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Phase 1/2
Phase 1/2
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Phase 1/2 top-line data released June 29, 2020 noted improved cardiac output by increasing heart contractility and decreasing vascular resistance.
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ITI-007 - Monotherapy (Study 404)
Bipolar depression
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Phase 3
Phase 3
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Phase 3 trial met primary endpoint - July 8, 2019.
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ITI-007 - Monotherapy (Study 401)
Bipolar depression
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Phase 3
Phase 3
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Phase 3 trial did not meet primary endpoint - July 8, 2019.
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Lumateperone
Schizophrenia
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Approved
Approved
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FDA Approval announced December 23, 2019.
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ITI-007-201
Agitation in patients with dementia
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Phase 3
Phase 3
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Phase 3 interim analysis December 18, 2018 noted trial to stop due to futility.
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Latest News
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Patients with stable symptoms of schizophrenia were switched from previous antipsychotic medications with no dose titration to CAPLYTA 42 mg for a 6-week treatment duration, then switched back to previous or another approved antipsychotic.
In patients with stable symptoms of schizophrenia, CAPLYTA was well-tolerated with low rates of metabolic and extrapyramidal symptoms (EPS) adverse events; schizophrenia symptoms remained stable and did not worsen from baseline.
NEW YORK, Jan. 21, 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 publication of results from the CAPLYTA clinical trial (ITI-007-303) in adult patients with schizophrenia. The article, "Safety and tolerability of lumateperone 42 mg: An open-label antipsychotic switch study in outpatients with stable schizophrenia" (Correll et al. 2021), was recently published online in Schizophrenia Research and is available here.
The objective of this 6-week open-label study was to evaluate the safety and tolerability of CAPLYTA with stable schizophrenia patients switched from another antipsychotic treatment. The most common drug-related treatment emergent adverse events during CAPLYTA treatment were somnolence (6.6%), headache (5.3%) and dry mouth (5.3%). Reports of EPS were low (1%).
After 6 weeks of CAPLYTA treatment, it was observed that the mean total cholesterol, low-density lipoprotein (LDL) cholesterol, body weight and prolactin levels decreased from baseline. At the conclusion of the treatment period with CAPLYTA, patients were switched back to their previous or another approved antipsychotic. In a prespecified secondary safety analysis, conducted 2 weeks after discontinuing CAPLYTA, it was observed that the mean total cholesterol, LDL cholesterol, body weight and prolactin levels increased. In this study, patients' schizophrenia symptoms remained stable and did not worsen from baseline.
These data further support the safety, tolerability and effectiveness of CAPLYTA in patients with schizophrenia and provide important information to clinicians.
"Weight gain and metabolic side effects or motor disturbances are leading reasons for healthcare providers to switch antipsychotics. Scientific results from studies that resemble a real world clinical setting and published in the medical literature provide important information for clinicians to make informed treatment decisions," said Dr. Christoph Correll, Professor of Psychiatry and Molecular Medicine at the Zucker School of Medicine at Hofstra/Northwell, New York. "CAPLYTA is a valuable addition to the armamentarium to help treat this challenging mental illness."
About ITI-007-303
ITI-007-303 is an open label, multicenter study conducted in the United States to investigate the safety and effectiveness of up to 1 year of treatment with CAPLYTA 42 mg in 301 stable patients with schizophrenia after switching from previous antipsychotic medications with no dose titration to CAPLYTA 42 mg. The study was conducted in 2 parts.
In Part 1, patients were eligible for participation if they had stable psychopathology and were able to be treated on an outpatient basis after Day 5. Entering the screening period on an existing antipsychotic was not a requirement of the study; therefore, medication history could not always be verified.
Patients meeting entry criteria were required to discontinue previous antipsychotics, tapering as appropriate, prior to starting CAPLYTA 42 mg with no dose titration. The primary objective assessed adverse events (AE), vital signs, laboratory tests, and extrapyramidal symptoms (EPS). Three hundred and one patients received CAPLYTA in the study and the 6-week treatment was completed by 218 (72.2%) of patients. The most common reason for treatment discontinuation was adverse events (8.9%). At the conclusion of the treatment period with CAPLYTA, patients were switched to their previous or another approved antipsychotic and a follow-up safety assessment was conducted approximately 2 weeks later.
In Part 2 of this study, patients were treated for up to 1 year and the favorable safety profile was maintained. Data from Part 2 of the study will be published in a separate report.
CAPLYTA® (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.
Important Safety Information
Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.
Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.
Warnings & Precautions: Antipsychotic drugs have been reported to cause:- Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
- Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
- Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
- Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
- Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
- Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
- Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
- Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
- Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
- Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
- Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.
Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.
Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.
Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).
Please click here to see full Prescribing Information including Boxed Warning.
About CAPLYTA (lumateperone)
CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. While the mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.
About Intra-Cellular Therapies
Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.
Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, whether clinical trial results will be predictive of future real-world results; our beliefs about the potential utility of our product candidates; and development efforts and plans under the caption "About Intra-Cellular Therapies." All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, the following: there are no guarantees that CAPLYTA will be commercially successful; we may encounter issues, delays or other challenges in commercializing CAPLYTA; the COVID-19 pandemic may negatively impact our commercial plans and sales for CAPLYTA; the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indication; challenges associated with execution of our sales activities, which in each case could limit the potential of our product; results achieved in CAPLYTA in the treatment of schizophrenia following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities; our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials or in clinical trials for other indications; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA; our reliance on collaborative partners and other third parties for development of our product candidates; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.
Contact:
Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333Burns McClellan, Inc.
Lisa Burns
[email protected]
212-213-0006MEDIA INQUIRIES:
Ana Fullmer
Corporate Media Relations W2Owcg
[email protected]
202-507-0130
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NEW YORK, Jan. 05, 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 that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 9:10 am ET.
The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.
About Intra-Cellular Therapies
Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.
CONTACT:
Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333Burns McClellan, Inc.
Lisa Burns
John Grimaldi
[email protected]
212-213-0006Source: Intra-Cellular Therapies Inc.
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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 μ-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.
About Lumateperone Long Acting Injectable (LLAI) formulation
The Company is developing a long-acting injectable formulation of lumateperone (LLAI) that is designed for once monthly administration by subcutaneous injection for the treatment of schizophrenia. Nonclinical studies in rodents and monkeys have shown the LLAI formulation is safe and well tolerated in single and once monthly multiple dose studies and sustains plasma lumateperone levels for 28 day or longer after each injection.
Pharmacodynamic studies have shown lumateperone acts as a potent serotonin 5-HT2A receptor antagonist with high binding affinity, as a postsynaptic D2 receptor antagonist with moderate binding affinity, as an inhibitor of the serotonin reuptake transporter (SERT) with moderate binding affinity. Lumateperone also has moderate binding affinity to the D1 receptor (which may contribute to the indirect activation of NMDA and AMPA neurotransmission). These drug targets are believed to play an important role in in schizophrenia, bipolar disorder, depressive disorders and other neuropsychiatric disorders. In vitro studies have shown lumateperone has a ~60-fold greater affinity for 5-HT2A receptors vs D2 receptors.
Lumateperone is being investigated for the treatment of bipolar depression, major depressive disorders and other neuropsychiatric and neurological disorders. Lumateperone is not FDA approved for these disorders. CAPLYTA 42 mg (lumateperone) is approved by the U.S. Food and Drug Administration for the treatment schizophrenia of adults.
About ITI-333
ITI333 is a novel compound that uniquely combines activity as an antagonist at serotonin 5-HT2A receptors and a partial agonist at μ-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. In addition, ITI-333 exhibits analgesic efficacy in acute and chronic preclinical models of pain supporting its potential utility in the management of pain.
ITI333's pharmacology is predominantly driven by high affinity binding to serotonin 5-HT2A (Ki = 8.3 nM) and μ-opioid (Ki = 11 nM) receptors. ITI333 shows modest affinity for dopamine D1 receptors, low affinity for κ-opioid receptors, and no binding to δ-opioid and NOP receptors.
In vivo, ITI-333 elicits potent analgesia in rodents that is blocked by the opioid antagonist, naloxone. Further, ITI-333 mitigates symptoms associated with opioid withdrawal and blocks reinstatement of opioid mediated behaviors; behaviors thought to be associated with a return to opioid use after a period of abstinence.
ITI-333 possesses low potential for abuse liability. Unlike opioid agonists, ITI-333 is not self-administered, does not develop physical tolerance/dependences and does not impair gastrointestinal and pulmonary function. This pharmacologic profile is unique and supports the study of ITI-333 in humans as a potential treatment for opioid use disorder and pain.
Intra-Cellular Therapies has received a grant from the National Institute on Drug Abuse as part of the NIH Helping to End Addiction Long-term initiative, or HEAL, to support the early clinical development of ITI-333 for the treatment of opioid use disorder.
CAPLYTA™ (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.
Important Safety Information
Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.
Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.
Warnings & Precautions: Antipsychotic drugs have been reported to cause:- Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
- Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
- Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
- Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
- Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
- Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
- Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
- Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
- Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
- Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
- Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.
Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.
Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.
Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).
Please click here to see full Prescribing Information including Boxed Warning.
About Intra-Cellular Therapies
Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, our beliefs about the potential utility of our product candidates; our belief that a long-acting injectable formulation of lumateperone could represent an important treatment option for patients; our expectation that we will continue to invest in our drug development pipeline; and development efforts and plans under the caption "About Intra-Cellular Therapies." All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, the following: the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues in ongoing or future trials and other development activities; our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials or in clinical trials for other indications; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA; our reliance on collaborative partners and other third parties for development of our product candidates; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.Contact:
Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333Burns McClellan, Inc.
Lisa Burns
John Grimaldi
[email protected]
212-213-0006 -
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Presentations highlight lumateperone's broad antidepressant effects in patients with bipolar disorder and in patients with schizophrenia with co-morbid depression
NEW YORK, Dec. 09, 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 two presentations at the 59th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) being held virtually, December 6-9, 2020.
- "Lumateperone (ITI-007) in the Treatment of Bipolar Depression: Efficacy Across Symptoms" (Poster T110).
This poster presented additional data from Study 404, a Phase 3 clinical trial evaluating lumateperone as monotherapy for the treatment of patients with bipolar depression. In this Study, lumateperone 42 mg met its primary endpoint of change from baseline at day 43 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p<.0001; effect size (ES) = 0.56).
A prospective analysis demonstrated lumateperone 42 mg significantly improved each of the 10 individual MADRS items versus placebo (P<.05 to P<.0001) indicating treatment with lumateperone results in reductions in all depression symptom domains.
Data presented also included the categorical shift in severity of depression symptoms as assessed by the MADRS single-item scores. Results showed a higher proportion of lumateperone patients than placebo patients had improvements in overall bipolar illness severity shifting from severe to moderate/mild or no illness. These findings are consistent with the broad antidepressant effects seen with lumateperone in our depression programs.
About the Montgomery-Åsberg Depression Rating Scale¹
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item, validated rating scale used to diagnose and rate the severity of depressive episodes and is an accepted regulatory endpoint in clinical trials of depression.
The scale includes questions on the following items: 1. Apparent sadness; 2. Reported sadness; 3. Inner tension; 4. Reduced sleep; 5. Reduced appetite; 6. Concentration difficulties; 7. Lassitude; 8. Inability to feel; 9. Pessimistic thoughts; and 10. Suicidal thoughts. Each item can be scored 0 (no abnormality) to 6 (severe) with the potential overall score ranging from 0 to 60.
- "Efficacy of Lumateperone (ITI-007) in Depression Symptoms Associated with Schizophrenia" (Poster T148).
This poster presented a post-hoc analysis from the lumateperone long-term safety study (Study 303) in patients with stable schizophrenia with comorbid depression (Calgary Depression Scale for Schizophrenia or CDSS score ≥6) who were switched from prior antipsychotics.
In patients with schizophrenia, depression symptoms are highly prevalent, even in stable patients following antipsychotic treatment. Depression associated with schizophrenia is linked to poorer patient outcomes, including increased risk of relapse and suicidality, worse functioning, and decreased quality of life.
In patients with stable schizophrenia and comorbid moderate-to-severe depression (CDSS≥6; n=80), lumateperone 42 mg significantly improved a broad range of depression symptoms. The mean baseline CDSS score in these patients was 7.6. Following one year of lumateperone 42 mg treatment, the mean CDSS score was reduced by 4.8 points (p=<.0001) to 2.4 points. Significant improvement compared with baseline was observed as early as Day 75, the first on-treatment CDSS assessment.
In this one year study lumateperone 42 mg significantly reduced a broad range of depression symptoms and maintained effectiveness over the entire treatment period as assessed by the CDSS. Each of the nine individual items of the CDSS were also analyzed and demonstrated significant improvement (P<.05 to P<.0001) versus baseline at day 75 (the earliest assessment).
Clinically meaningful reduction of depression symptoms (response defined as ≥50% reduction from baseline on the CDSS) was achieved in 50% of patients with comorbid depression at baseline.
These results support the potential benefits of lumateperone 42 mg in treating depression symptoms associated with schizophrenia and advancing the development of lumateperone in a variety of depressive disorders.
About the Calgary Depression Scale for Schizophrenia²
Calgary Depression Scale for Schizophrenia (CDSS) is a 9-item, validated scale used specifically to assess depression in people with schizophrenia. The scale was developed from, and validated against, the Hamilton Depression Rating Scale (HDRS), Beck Depression Inventory (BDI), and the Brief Psychiatric Rating Scale (BPRS). The CDSS scale was also validated against the MADRS³. The scale uniquely distinguishes depressive symptoms from positive, negative, and extrapyramidal symptoms in patients with schizophrenia. The CDSS, therefore, is the most suitable measure of depression in schizophrenia when compared to other scales that do not reliably distinguish depression from other symptoms associated with schizophrenia.
The scales include questions on the following items: 1. Depression; 2. Hopelessness; 3. Self-Depreciation; 4. Guilty Ideas of Reference; 5. Pathological Guilt 6. Morning Depression; 7. Early Wakening; 8. Suicide; and 9. Observed Depression. Each item can be scored 0 to 3 (Absent, Mild, Moderate, or Severe) with the potential overall score ranging from 0 to 27.
¹ Montgomery SA, Asberg M. "A new depression scale designed to be sensitive to change". British Journal of Psychiatry. 1979; 134 (4): 382–89.
² Addington D, Addington J, Schissel B. "A depression rating scale for schizophrenics". Schizophr Res. 1990;3 (4):247–251.
³ Lako et al. "A systematic review of instruments to measure depressive symptoms in patients with schizophrenia". Journal of Affective Disorders 140 (2012) 38–47.
CAPLYTA® (lumateperone) is indicated for the treatment of schizophrenia in adults. CAPLYTA is available in 42 mg capsules.
Important Safety Information
Boxed Warning: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.
Warnings & Precautions: Antipsychotic drugs have been reported to cause:
- Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
- Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
- Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
- Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
- Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
- Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
- Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
- Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
- Sleepiness and Trouble Concentrating. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
- Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
- Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.
Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT inhibitors.
Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Use of CAPLYTA should be avoided in patients with moderate or severe liver problems.
Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).
Please see click here for full Prescribing Information, including Boxed Warning.
CAPLYTA is a registered trademark of Intra-Cellular Therapies, Inc.
© 2020 Intra-Cellular Therapies, Inc. All rights reserved. 3/2020 US-CAP-2000150About CAPLYTA (lumateperone)
CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic approved for the treatment of schizophrenia of adults. While the mechanism of action of CAPLYTA in the treatment of schizophrenia is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.
CAPLYTA (lumateperone) is being investigated for the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders. CAPLYTA is not FDA approved for these disorders.
About Intra-Cellular Therapies
Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases.Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, our expectations regarding the potential benefits of lumateperone 42 mg in treating depression symptoms associated with schizophrenia and the potential to advance the development of lumateperone as a potential treatment for a variety of depressive disorders; our beliefs about the potential utility of our product candidates; and development efforts and plans under the caption "About Intra-Cellular Therapies." All such forward-looking statements are based on management's present expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, the following: the COVID-19 pandemic may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; any other impacts on our business as a result of or related to the COVID-19 pandemic; risks associated with our current and planned clinical trials; we may encounter unexpected safety or tolerability issues with CAPLYTA following commercial launch for the treatment of schizophrenia or in ongoing or future trials and other development activities; our other product candidates may not be successful or may take longer and be more costly than anticipated; product candidates that appeared promising in earlier research and clinical trials may not demonstrate safety and/or efficacy in larger-scale or later clinical trials or in clinical trials for other indications; our proposals with respect to the regulatory path for our product candidates may not be acceptable to the FDA; our reliance on collaborative partners and other third parties for development of our product candidates; and the other risk factors detailed in our public filings with the Securities and Exchange Commission. All statements contained in this press release are made only as of the date of this press release, and we do not intend to update this information unless required by law.Contact:
Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333Burns McClellan, Inc.
Lisa Burns
[email protected]
212-213-0006MEDIA INQUIRIES:
Ana Fullmer
Corporate Media Relations W2Owcg
[email protected] - "Lumateperone (ITI-007) in the Treatment of Bipolar Depression: Efficacy Across Symptoms" (Poster T110).
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NEW YORK, Nov. 30, 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 that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to participate in a fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on Wednesday, December 2, 2020 at 9:15am ET.
The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.
About Intra-Cellular Therapies
Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases. For more information, please visit www.intracellulartherapies.com.
CONTACT:
Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D.
Vice President, Corporate Communications and Investor Relations
646-440-9333Burns McClellan, Inc.
Lisa Burns
[email protected]
212-213-0006