Lexeo Therapeutics to Present New Interim Data from Phase 1/2 Trial of LX1001 at the Clinical Trials on Alzheimer’s Disease (CTAD) 2024 Conference
Lexeo Therapeutics (Nasdaq: LXEO) will present interim data from its Phase 1/2 trial of LX1001 at the Clinical Trials on Alzheimer's Disease (CTAD) conference in Madrid, Spain. The presentation will include new safety and biomarker data from four dose cohorts of LX1001, an AAVrh10-based gene therapy designed to deliver the protective APOE2 gene to APOE4 homozygotes with Alzheimer's disease.
The trial, which completed enrollment in Q4 2023, evaluates safety and tolerability in 15 patients with Alzheimer's disease and two copies of the APOE4 allele. The presentation will review safety and efficacy measures, including protein expression and tau and amyloid biomarkers. It will feature 12-month data for Cohorts 1-3 and 6-month data for Cohort 4.
Lexeo Therapeutics (Nasdaq: LXEO) presenterà dati intermedi del suo studio di Fase 1/2 su LX1001 durante la conferenza Clinical Trials on Alzheimer's Disease (CTAD) a Madrid, Spagna. La presentazione includerà nuovi dati sulla sicurezza e sui biomarcatori provenienti da quattro coorti di dosaggio di LX1001, una terapia genica basata su AAVrh10 progettata per fornire il gene protettivo APOE2 ai portatori omozigoti del gene APOE4 affetti da malattia di Alzheimer.
Lo studio, che ha completato l'arruolamento nel Q4 2023, valuta la sicurezza e la tollerabilità in 15 pazienti con malattia di Alzheimer e due copie dell'allele APOE4. La presentazione esaminerà le misure di sicurezza ed efficacia, inclusa l'espressione proteica e i biomarcatori di tau e amiloide. Presenterà dati a 12 mesi per le Coorti 1-3 e dati a 6 mesi per la Coorte 4.
Lexeo Therapeutics (Nasdaq: LXEO) presentará datos intermedios de su ensayo de Fase 1/2 de LX1001 en la conferencia Clinical Trials on Alzheimer's Disease (CTAD) en Madrid, España. La presentación incluirá nuevos datos de seguridad y biomarcadores de cuatro cohortes de dosis de LX1001, una terapia génica basada en AAVrh10 diseñada para entregar el gen protector APOE2 a los homozygotos APOE4 con enfermedad de Alzheimer.
El ensayo, que completó su reclutamiento en el Q4 de 2023, evalúa la seguridad y la tolerabilidad en 15 pacientes con enfermedad de Alzheimer y dos copias del alelo APOE4. La presentación revisará las medidas de seguridad y eficacia, incluyendo la expresión de proteínas y biomarcadores de tau y amiloide. Incluirá datos a 12 meses para las Cohortes 1-3 y datos a 6 meses para la Cohorte 4.
Lexeo Therapeutics (Nasdaq: LXEO)는 스페인 마드리드에서 열리는 알츠하이머병 임상 시험(CAD) 회의에서 LX1001의 제1/2상 시험 중간 데이터를 발표할 예정입니다. 발표에는 LX1001의 네 가지 용량 집단에 대한 새로운 안전성 및 바이오마커 데이터가 포함됩니다. LX1001은 알츠하이머병을 앓고 있는 APOE4 동형접합체에 보호 유전자 APOE2를 전달하도록 설계된 AAVrh10 기반 유전자 치료제입니다.
이 연구는 2023년 4분기에 모집을 완료했으며 알츠하이머병 환자 15명의 안전성 및 내약성을 평가합니다. 이 발표는 단백질 발현 및 타우와 아밀로이드 바이오마커를 포함한 안전성 및 효능 측정을 검토할 것입니다. 1-3군에 대한 12개월 데이터 및 4군에 대한 6개월 데이터가 포함될 것입니다.
Lexeo Therapeutics (Nasdaq: LXEO) présentera des données intermédiaires de son essai de Phase 1/2 sur LX1001 lors de la conférence Clinical Trials on Alzheimer's Disease (CTAD) à Madrid, Espagne. La présentation comprendra de nouvelles données de sécurité et de biomarqueurs provenant de quatre cohortes de dosage de LX1001, une thérapie génique basée sur AAVrh10 conçue pour délivrer le gène protecteur APOE2 aux homozygotes APOE4 atteints de la maladie d'Alzheimer.
L'essai, qui a terminé son recrutement au quatrième trimestre 2023, évalue la sécurité et la tolérabilité chez 15 patients atteints de la maladie d'Alzheimer ayant deux copies de l'allèle APOE4. La présentation examinera les mesures de sécurité et d'efficacité, y compris l'expression protéique ainsi que les biomarqueurs de tau et d'amyloïde. Elle présentera des données sur 12 mois pour les Cohortes 1-3 et des données sur 6 mois pour la Cohorte 4.
Lexeo Therapeutics (Nasdaq: LXEO) wird auf der Konferenz Clinical Trials on Alzheimer's Disease (CTAD) in Madrid, Spanien, Zwischenergebnisse aus seiner Phase 1/2-Studie zu LX1001 präsentieren. Die Präsentation wird neue Sicherheits- und Biomarker-Daten aus vier Dosierungs-Kohorten von LX1001 umfassen, einer AAVrh10-basierten Gentherapie, die darauf abzielt, das schützende APOE2-Gen an homozygote APOE4-Träger mit Alzheimer-Krankheit zu liefern.
Die Studie, die im Q4 2023 die Rekrutierung abgeschlossen hat, bewertet Sicherheit und Verträglichkeit bei 15 Patienten mit Alzheimer-Krankheit und zwei Kopien des APOE4 Allels. Die Präsentation wird Sicherheits- und Wirksamkeitsmessungen, einschließlich der Proteinausdrücke sowie Tau- und Amyloid-Biomarker, überprüfen. Es werden 12-Monats-Daten für Kohorten 1-3 und 6-Monats-Daten für Kohorte 4 vorgestellt.
- Completed enrollment of 15 patients in Q4 2023
- Selected for late-breaking oral presentation at CTAD conference
- Will present new safety and biomarker data from four dose cohorts
- Targeting underlying genetic cause of APOE4-associated Alzheimer's disease
- None.
Late-breaking oral presentation to highlight safety and efficacy of LX1001 across four dose cohorts
NEW YORK, Oct. 22, 2024 (GLOBE NEWSWIRE) -- Lexeo Therapeutics, Inc. (Nasdaq: LXEO), a clinical stage genetic medicine company dedicated to pioneering treatments for genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease, today announced that interim data from the ongoing Phase 1/2 trial (NCT03634007) of LX1001 have been selected as a late-breaking oral presentation at the Clinical Trials on Alzheimer’s Disease (CTAD) conference taking place October 29 - November 1, 2024, in Madrid, Spain. The presentation will include new safety and biomarker data from four dose cohorts of LX1001, an AAVrh10-based gene therapy candidate designed to deliver the protective APOE2 gene into the central nervous systems of APOE4 homozygotes with Alzheimer’s disease.
“APOE4-associated Alzheimer’s disease is a devastating, genetically distinct condition and despite recent therapeutic advances, patients with this genetic profile have limited effective treatment options,” said Dr. Sandi See Tai, Chief Development Officer of Lexeo Therapeutics. “We look forward to presenting new data from the first clinical trial seeking to address the underlying genetic cause of APOE4-associated Alzheimer’s disease with a targeted approach.”
The Phase 1/2 clinical trial is an open-label, dose-ranging study evaluating the safety and tolerability of LX1001 in fifteen patients with Alzheimer’s disease and two copies of the APOE4 allele (APOE4 homozygous patients). Study enrollment was completed in Q4 2023. The presentation will review safety as well as multiple measures of efficacy, including protein expression and tau and amyloid biomarkers. 12-month data will be presented for all patients in Cohorts 1-3, and 6-month data for Cohort 4.
Oral presentation details:
- Title: Safety and Preliminary Efficacy of AAV Gene Therapy (LX1001) in Patients with APOE4 Homozygote Alzheimer’s Disease – Interim Data from a Phase 1/2, Open-Label, 52-Week, Multicenter Study, Abstract #486
- Date/Time: Wednesday, October 30, at 10:50AM, CET (5:50AM ET)
About LX1001
LX1001 is an AAVrh10-based gene therapy candidate for the treatment of APOE4-homozygous Alzheimer’s disease. Individuals homozygous for APOE4, an allele of the gene APOE, are approximately 15 times more likely to develop Alzheimer’s disease than the general population, and it is estimated that there are approximately 900,000 APOE4 homozygous patients with Alzheimer’s disease in the United States. Conversely, individuals homozygous for the APOE allele APOE2 are
About Lexeo Therapeutics
Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of cardiovascular and APOE4-associated Alzheimer’s disease programs.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, our expectations and plans regarding our current product candidates and programs, including statements regarding the potential benefits of LX1001 for the treatment of Alzheimer’s disease and the timing for receipt and announcement of data from its clinical trials, and the timing and likelihood of potential regulatory approval. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Lexeo believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements. These forward-looking statements are based upon current information available to the company as well as certain estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Lexeo’s filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different from those indicated by such forward looking statements as a result of many factors, including but not limited to: risks and uncertainties related to global macroeconomic conditions and related volatility; expectations regarding the initiation, progress, and expected results of Lexeo’s preclinical studies, clinical trials and research and development programs; the unpredictable relationship between preclinical study results and clinical study results; delays in submission of regulatory filings or failure to receive regulatory approval; liquidity and capital resources; and other risks and uncertainties identified in Lexeo’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024, filed with the SEC on August 12, 2024, and subsequent future filings Lexeo may make with the SEC. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Lexeo claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Lexeo expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
Media:
Media@lexeotx.com
Investors:
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ctanzi@kendallir.com
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