Intra-Cellular Therapies Announces Positive Topline Results in Phase 3 Trial Evaluating CAPLYTA for the Prevention of Relapse in Patients with Schizophrenia
Intra-Cellular Therapies (ITCI) announced positive results from Study 304, evaluating CAPLYTA (lumateperone) for preventing schizophrenia relapse. The trial demonstrated significantly longer time to relapse in patients treated with lumateperone compared to placebo (p=0.0002), with only 16.4% of lumateperone patients relapsing versus 38.6% in the placebo group. The treatment showed a 63% reduction in relapse risk versus placebo. The drug was generally well-tolerated, with headache being the most common adverse event occurring at ≥5% and twice the placebo rate. The study also met its key secondary endpoint of time to all-cause discontinuation (p=0.0007).
Intra-Cellular Therapies (ITCI) ha annunciato risultati positivi dallo Studio 304, che valuta CAPLYTA (lumateperone) per la prevenzione delle ricadute nella schizofrenia. La sperimentazione ha dimostrato un tempo significativamente più lungo fino alla ricaduta nei pazienti trattati con lumateperone rispetto al placebo (p=0.0002), con solo il 16,4% dei pazienti in trattamento con lumateperone che ha avuto una ricaduta contro il 38,6% nel gruppo placebo. Il trattamento ha mostrato una riduzione del 63% nel rischio di ricaduta rispetto al placebo. Il farmaco è stato generalmente ben tollerato, con l'emicrania che è stata l'evento avverso più comune, registrato in ≥5% dei casi e il doppio rispetto al tasso di placebo. Lo studio ha inoltre raggiunto il suo obiettivo secondario principale riguardante il tempo fino all'interruzione per qualsiasi causa (p=0.0007).
Intra-Cellular Therapies (ITCI) anunció resultados positivos del Estudio 304, que evalúa CAPLYTA (lumateperona) para prevenir recaídas en la esquizofrenia. El ensayo demostró un tiempo significativamente más prolongado hasta la recaída en pacientes tratados con lumateperona en comparación con el placebo (p=0.0002), con solo el 16.4% de los pacientes tratados con lumateperona teniendo recaídas frente al 38.6% en el grupo placebo. El tratamiento mostró una reducción del 63% en el riesgo de recaída en comparación con el placebo. El medicamento fue generalmente bien tolerado, siendo el dolor de cabeza el efecto adverso más común que ocurrió en ≥5% y el doble que la tasa de placebo. El estudio también cumplió con su objetivo secundario clave sobre el tiempo hasta la interrupción por cualquier causa (p=0.0007).
Intra-Cellular Therapies (ITCI)는 정신분열증 재발 방지를 위한 CAPLYTA (루마테페론)의 304 연구에서 긍정적인 결과를 발표했습니다. 시험에서는 루마테페론으로 치료받은 환자에서 플라시보보다 재발까지의 시간이 유의미하게 더 길어졌음을 보여주었습니다 (p=0.0002). 루마테페론 치료 환자 중 16.4%만이 재발한 반면, 플라시보 그룹에서는 38.6%가 재발했습니다. 이 치료법은 플라시보에 비해 63%의 재발 위험 감소를 나타냈습니다. 이 약물은 일반적으로 잘 견딜 수 있었고, 두통이 가장 흔한 부작용으로 ≥5%에서 발생했으며 플라시보의 두 배에 달했습니다. 연구는 또한 모든 원인에 대한 중단 시간이라는 주요 2차 목표도 달성했습니다 (p=0.0007).
Intra-Cellular Therapies (ITCI) a annoncé des résultats positifs de l'étude 304, évaluant CAPLYTA (lumateperone) pour prévenir les rechutes de schizophrénie. L'essai a montré un délai significativement plus long avant la rechute chez les patients traités par lumateperone par rapport au placebo (p=0.0002), avec seulement 16,4% des patients sous lumateperone ayant rechuté contre 38,6% dans le groupe placebo. Le traitement a montré une réduction de 63% du risque de rechute par rapport au placebo. Le médicament a généralement bien été toléré, la céphalée étant l'effet indésirable le plus courant survenant chez ≥5% des patients, soit le double du taux de placebo. L'étude a également atteint son objectif secondaire clé sur le temps jusqu'à l'arrêt pour toutes causes (p=0.0007).
Intra-Cellular Therapies (ITCI) gab positive Ergebnisse aus Studie 304 bekannt, die CAPLYTA (Lumateperon) zur Verhinderung eines Rückfalls bei Schizophrenie bewertet. Die Studie zeigte eine signifikant längere Zeit bis zum Rückfall bei Patienten, die mit Lumateperon behandelt wurden, im Vergleich zur Placebogruppe (p=0.0002). Nur 16,4% der Lumateperon-Patienten erlitten einen Rückfall, während dies bei 38,6% der Placebo-Gruppe der Fall war. Die Behandlung führte zu einer 63%igen Reduktion des Rückfallrisikos im Vergleich zum Placebo. Das Medikament wurde insgesamt gut vertragen, wobei Kopfschmerzen das häufigste unerwünschte Ereignis waren, das bei ≥5% auftrat, doppelt so hoch wie die Placebo-Rate. Die Studie erfüllte auch ihr wichtiges sekundäres Endziel, die Zeit bis zur Unterbrechung aus beliebigem Grund (p=0.0007).
- Significant 63% reduction in relapse risk compared to placebo
- Lower relapse rate in treatment group (16.4%) vs placebo (38.6%)
- Met primary endpoint with statistical significance (p=0.0002)
- Met key secondary endpoint of time to all-cause discontinuation
- Favorable safety and tolerability profile
- 16.4% of patients still experienced relapse despite treatment
- Headache reported as adverse event at twice the rate of placebo
Insights
The Phase 3 trial results for CAPLYTA represent a significant clinical advancement in schizophrenia maintenance treatment. The
This data substantially strengthens CAPLYTA's market position in the
These results will likely drive significant revenue growth for ITCI. The maintenance therapy indication expands CAPLYTA's addressable market and should increase prescription persistence. The strong efficacy data strengthens CAPLYTA's competitive position against established antipsychotics like Abilify and Latuda.
With a market cap of
The efficacy and safety of CAPLYTA (lumateperone) as a maintenance treatment in adults with schizophrenia was demonstrated in a randomized withdrawal trial
The study demonstrated a statistically significant (p=0.0002) longer time to relapse in schizophrenia patients treated with lumateperone compared to placebo
BEDMINSTER, N.J., Nov. 05, 2024 (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 positive results from Study 304 evaluating the efficacy and safety of lumateperone 42 mg for the prevention of relapse in adult patients with schizophrenia.
“Schizophrenia is a chronic, serious mental illness characterized by the occurrence of acute psychotic episodes that cumulatively worsen disease prognosis. The control of symptoms and the prevention of relapses is critical to improving long-term patient outcomes. We are very pleased that the results from Study 304, a randomized withdrawal trial, demonstrated efficacy along with favorable safety and tolerability which support the benefit of continued long-term treatment with lumateperone,” said Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies.
On the primary endpoint, time to relapse during the double-blind treatment phase was significantly longer in patients receiving lumateperone compared to those receiving placebo (p=0.0002). There were 18 relapses (
Lumateperone also met the key secondary endpoint, time to all cause discontinuation during the double-blind phase (p=0.0007).
In this study, lumateperone was generally safe and well tolerated. In the double-blind phase, the most commonly reported adverse event that was observed at a rate greater than or equal to
About Study 304
This study was a multicenter, multi-national, randomized, double-blind, placebo-controlled, parallel group study of lumateperone for the prevention of symptomatic relapse in adult patients with schizophrenia. This approximately 47-week study included an 18-week open-label phase where patients with schizophrenia were treated with lumateperone 42 mg per day. Patients who met the stabilization criteria during the open-label period progressed to the double-blind treatment phase. These patients were randomized to continue on lumateperone 42 mg (N=114) or switched to placebo (N=114) for up to 26 weeks or until the time to relapse occurred. The primary endpoint was time to first symptom relapse and the key secondary endpoint was time to all cause discontinuation during the double-blind phase.
CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.
Important Safety Information
Boxed Warnings:
- 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.
- Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.
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.
- Potential for Cognitive and Motor Impairment. 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. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 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. Dose reduction is recommended for patients with moderate or severe hepatic impairment.
Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth.
CAPLYTA is available in 10.5 mg, 21 mg, and 42 mg capsules.
Please click here to see full Prescribing Information including Boxed Warning.
About CAPLYTA (lumateperone)
CAPLYTA 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA 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.
Lumateperone is being studied for the treatment of major depressive disorder, and other psychiatric and neurological disorders. Lumateperone is not approved by the U.S. Food and Drug Administration, or FDA, 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. 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, our expectations regarding the commercialization of CAPLYTA; our plans to conduct clinical or non-clinical trials and the timing of developments with respect to those trials, including enrollment, initiation or completion of clinical conduct, or the availability or reporting of results; plans to make regulatory submissions to the FDA and the timing of such submissions; whether clinical trial results will be predictive of future real-world results; whether CAPLYTA will serve an unmet need; the goals of our development programs; 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; whether CAPLYTA receives adequate reimbursement from third-party payors; the degree to which CAPLYTA receives acceptance from patients and physicians for its approved indications; 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 and bipolar depression following commercial launch of the product may be different than observed in clinical trials, and may vary among patients; challenges associated with supply and manufacturing activities, which in each case could limit our sales and the availability of our product; 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 bipolar depression or in ongoing or future trials and other development activities; there is no guarantee that a generic equivalent of CAPLYTA will not be approved and enter the market before the expiration of our patents; there is no guarantee that our planned supplemental NDA for the treatment of major depressive disorder, or MDD, will be submitted or approved, if at all, on the timeline that we expect; 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; impacts on our business, including on the commercialization of CAPLYTA and our clinical trials, as a result of the COVID-19 pandemic, the conflicts in Ukraine, Russia and the Middle East, global economic uncertainty, inflation, higher interest rates or market disruptions; 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
646-440-9333
Burns McClellan, Inc.
Cameron Radinovic
cradinovic@burnsmc.com
646-930-4406
FAQ
What were the results of ITCI's Phase 3 CAPLYTA relapse prevention trial?
What side effects were reported in ITCI's CAPLYTA Phase 3 trial?
Did CAPLYTA meet its primary endpoint in the Phase 3 schizophrenia trial?
