Intra-Cellular Therapies Announces Presentations at the 2024 Psych Congress and NEI Congress
Intra-Cellular Therapies (ITCI) announced presentations of pivotal studies evaluating lumateperone (CAPLYTA) as an adjunctive therapy for major depressive disorder (MDD). Studies 501 and 502 demonstrated robust efficacy with significant separation from placebo in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score, showing 4.9 and 4.5 points difference respectively, with effect sizes of 0.61 and 0.56. The results were supported by strong performance in both CGI-S and QIDS-SR scales. The drug showed a favorable metabolic, weight, and movement disorder profile, positioning CAPLYTA as a potential leading treatment option for mood disorders.
Intra-Cellular Therapies (ITCI) ha annunciato le presentazioni di studi chiave che valutano lumateperone (CAPLYTA) come terapia aggiuntiva per il disturbo depressivo maggiore (MDD). Gli studi 501 e 502 hanno dimostrato una notevole efficacia con una separazione significativa rispetto al placebo nel punteggio totale della Montgomery–Åsberg Depression Rating Scale (MADRS), mostrando rispettivamente una differenza di 4,9 e 4,5 punti, con dimensioni dell'effetto di 0,61 e 0,56. I risultati sono stati sostenuti da un'ottima prestazione sia nella scala CGI-S che nella scala QIDS-SR. Il farmaco ha mostrato un profilo metabolico, di peso e di disturbi del movimento favorevole, posizionando CAPLYTA come una potenziale opzione terapeutica di punta per i disturbi dell'umore.
Intra-Cellular Therapies (ITCI) anunció presentaciones de estudios fundamentales que evalúan lumateperona (CAPLYTA) como terapia complementaria para el trastorno depresivo mayor (MDD). Los estudios 501 y 502 demostraron una eficacia robusta con una separación significativa del placebo en la puntuación total de la Montgomery–Åsberg Depression Rating Scale (MADRS), mostrando una diferencia de 4.9 y 4.5 puntos respectivamente, con tamaños del efecto de 0.61 y 0.56. Los resultados fueron respaldados por un fuerte rendimiento en las escalas CGI-S y QIDS-SR. El medicamento mostró un perfil metabólico, de peso y de trastornos del movimiento favorable, posicionando a CAPLYTA como una potencial opción de tratamiento líder para los trastornos del estado de ánimo.
Intra-Cellular Therapies (ITCI)는 루마테페론 (CAPLYTA)를 주요 우울 장애 (MDD)에 대한 보조 요법으로 평가하는 주요 연구 발표를 발표했습니다. 연구 501 및 502는 몬트고메리-아스버그 우울증 척도 (MADRS)의 총 점수에서 위약 대비 4.9점 및 4.5점의 유의미한 차이를 보여주며 강력한 효능을 입증했습니다. 효과 크기는 각각 0.61 및 0.56입니다. 이 결과는 CGI-S 및 QIDS-SR 척도에서의 강력한 성과에 의해 뒷받침되었습니다. 이 약물은 대사, 체중 및 운동 장애 프로필이 우호적이며, CAPLYTA를 기분 장애에 대한 잠재적인 주요 치료 옵션으로 위치시킵니다.
Intra-Cellular Therapies (ITCI) a annoncé des présentations d'études clés évaluant lumatépérone (CAPLYTA) en tant que thérapie adjuvante pour le trouble dépressif majeur (MDD). Les études 501 et 502 ont démontré une efficacité robuste avec une séparation significative par rapport au placebo dans le score total de la Montgomery–Åsberg Depression Rating Scale (MADRS), montrant respectivement une différence de 4,9 et 4,5 points, avec des tailles d'effet de 0,61 et 0,56. Les résultats ont été soutenus par une forte performance tant dans les échelles CGI-S que QIDS-SR. Le médicament a montré un profil métabolique, de poids et de troubles du mouvement favorable, plaçant CAPLYTA comme une option de traitement potentiellement de premier plan pour les troubles de l'humeur.
Intra-Cellular Therapies (ITCI) gab bekannt, dass sie wichtige Studien präsentieren, die Lumateperon (CAPLYTA) als unterstützende Therapie bei schweren depressiven Störungen (MDD) bewerten. Die Studien 501 und 502 zeigten eine robuste Wirksamkeit mit einem signifikanten Unterschied zum Placebo in der Gesamtnote der Montgomery–Åsberg Depression Rating Scale (MADRS), wobei ein Unterschied von 4,9 bzw. 4,5 Punkten und Effektstärken von 0,61 bzw. 0,56 festgestellt wurden. Die Ergebnisse wurden durch eine starke Leistung sowohl in den CGI-S- als auch in den QIDS-SR-Skalen unterstützt. Das Medikament zeigte ein günstiges Profil in Bezug auf Metabolismus, Gewicht und Bewegungsstörungen, was CAPLYTA als potenzielle führende Behandlungsoption für Stimmungsschwankungen positioniert.
- Strong efficacy demonstrated in both Phase 3 studies with significant MADRS score improvements
- Large effect sizes of 0.61 and 0.56 in Studies 501 and 502 respectively
- Favorable safety profile regarding metabolic, weight, and movement disorder outcomes
- None.
Insights
The Phase 3 clinical trial results for lumateperone as an adjunctive therapy in MDD represent significant progress. The data shows impressive efficacy with MADRS score improvements of 4.9 and 4.5 points versus placebo in Studies 501 and 502 respectively, with robust effect sizes of 0.61 and 0.56. These are clinically meaningful differences that exceed typical thresholds for antidepressant efficacy.
The multi-scale validation across MADRS, CGI-S and QIDS-SR strengthens the reliability of these findings. Particularly noteworthy is the favorable metabolic, weight and movement disorder profile, which addresses common concerns with existing adjunctive therapies. This positions CAPLYTA advantageously in the competitive landscape for MDD treatment, especially for patients who have had an inadequate response to antidepressants alone.
Presentations include results from two pivotal studies (Studies 501 and 502) evaluating lumateperone as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD)
Results show robust efficacy and favorable safety and tolerability profile for CAPLYTA
BEDMINSTER, N.J., Nov. 07, 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 presentations about lumateperone including the results from Phase 3 adjunctive Major Depressive Disorder (MDD) Studies 501 and 502 at Psych Congress held October 29- November 2 in Boston and Neuroscience Education Institute (NEI) Congress being held November 7-10 in Colorado Springs.
Studies 501 and 502 demonstrated robust efficacy of lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD. In the primary endpoint, the Montgomery–Åsberg Depression Rating Scale (MADRS) total score, lumateperone demonstrated a large separation versus placebo of 4.9 points in Study 501 and 4.5 points in Study 502 with robust effect sizes of 0.61 and 0.56 respectively. This efficacy was confirmed in both studies not only by the primary endpoint, the MADRS total score, but also by the strong results in the clinician rated Clinical Global Impression Scale for Severity of Illness (CGI-S) scale and the patient reported Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) scale. CAPLYTA’s efficacy results were complemented with a favorable metabolic, weight and movement disorder profile.
In the adjunctive MDD setting these data present a compelling clinical profile for lumateperone in the treatment of MDD. These results further support the Company’s vision for CAPLYTA to become a leading option for patients and providers across mood disorders.
Presentations at Psych Congress and NEI Congress as follows:
Study 501: “Lumateperone as Adjunctive Therapy in Patients With Major Depressive Disorder: Results From a Randomized, Double-blind, Phase 3 Trial.”
Study 502: “Adjunctive Lumateperone in Patients With Major Depressive Disorder: Results From an Additional Randomized, Double-Blind, Phase 3 Trial.”
Study 403: “Lumateperone Treatment in Patients With Major Depressive Disorder With Mixed Features: Results From a Randomized Controlled Trial.”
Additional Presentation at Psych Congress:
Study 403: “Lumateperone in the Treatment of Major Depressive Disorder and Bipolar Depression With Mixed Features: Efficacy Across Symptoms.”
About Major Depressive Disorder
Major Depressive Disorder (MDD) is a common mood disorder in the U.S. affecting an estimated 21 million adults each year. Depressive disorders are the number two cause of years lived with disability in the world. Symptoms include sadness, hopelessness, helplessness, feelings of guilt, irritability, loss of interest in formerly pleasurable activities, cognitive impairment, disturbed sleep patterns, and suicide ideation or behavior. MDD can cause severe functional impairment, adversely affecting interpersonal relationships, and may impact quality of life. Approximately two-thirds of patients with depression fail to achieve remission with first-line treatment.
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 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. 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 sNDA for the treatment of 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 MADRS score improvements for CAPLYTA in ITCI's MDD Studies 501 and 502?
What safety profile did CAPLYTA demonstrate in ITCI's MDD clinical trials?
Where were ITCI's CAPLYTA MDD study results presented in 2024?
