NewAmsterdam Pharma to Present New Clinical and Preclinical Data at 93rd EAS Congress
NewAmsterdam Pharma will present new clinical and preclinical data for its drug obicetrapib at the 93rd European Atherosclerosis Society Congress in Glasgow. The presentations include results from the BROADWAY and TANDEM Phase 3 trials, focusing on the drug's effectiveness in treating hypercholesterolemia.
Key presentations will highlight the fixed-dose combination of obicetrapib with ezetimibe for LDL-C reduction and the drug's safety profile in high cardiovascular risk patients. Additional sessions will cover obicetrapib's impact on atherosclerosis, vascular inflammation, and its effects when combined with moderate-dose statins.
The congress, scheduled for May 4-7, 2025, will feature multiple presentations across different sessions, including late-breaker oral presentations, poster networking sessions, and workshops. The research demonstrates obicetrapib's potential as a novel, oral, low-dose therapy for patients with elevated LDL-C who don't respond well to existing treatments.
NewAmsterdam Pharma presenterà nuovi dati clinici e preclinici sul suo farmaco obicetrapib al 93° Congresso della European Atherosclerosis Society a Glasgow. Le presentazioni includeranno i risultati degli studi di Fase 3 BROADWAY e TANDEM, focalizzati sull'efficacia del farmaco nel trattamento dell'ipercolesterolemia.
Le sessioni principali metteranno in evidenza la combinazione a dose fissa di obicetrapib con ezetimibe per la riduzione del LDL-C e il profilo di sicurezza del farmaco in pazienti ad alto rischio cardiovascolare. Ulteriori interventi tratteranno l'impatto di obicetrapib sull'aterosclerosi, l'infiammazione vascolare e i suoi effetti in associazione con statine a dose moderata.
Il congresso, previsto dal 4 al 7 maggio 2025, includerà diverse presentazioni in varie sessioni, comprese presentazioni orali late-breaker, sessioni di poster e workshop. La ricerca evidenzia il potenziale di obicetrapib come terapia orale innovativa a basso dosaggio per pazienti con LDL-C elevato che rispondono poco ai trattamenti attuali.
NewAmsterdam Pharma presentará nuevos datos clínicos y preclínicos de su fármaco obicetrapib en el 93º Congreso de la European Atherosclerosis Society en Glasgow. Las presentaciones incluirán resultados de los ensayos de Fase 3 BROADWAY y TANDEM, centrados en la eficacia del medicamento para tratar la hipercolesterolemia.
Las presentaciones clave destacarán la combinación de dosis fija de obicetrapib con ezetimiba para la reducción del LDL-C y el perfil de seguridad del fármaco en pacientes con alto riesgo cardiovascular. Otras sesiones abordarán el impacto de obicetrapib en la aterosclerosis, la inflamación vascular y sus efectos cuando se combina con estatinas en dosis moderadas.
El congreso, programado del 4 al 7 de mayo de 2025, contará con múltiples presentaciones en diferentes sesiones, incluyendo presentaciones orales late-breaker, sesiones de pósters y talleres. La investigación demuestra el potencial de obicetrapib como una terapia oral novedosa y de baja dosis para pacientes con LDL-C elevado que no responden bien a los tratamientos existentes.
NewAmsterdam Pharma는 글래스고에서 열리는 제93회 유럽 동맥경화학회(European Atherosclerosis Society) 총회에서 신약 오비세트라립(obicetrapib)의 새로운 임상 및 비임상 데이터를 발표할 예정입니다. 발표에는 BROADWAY 및 TANDEM 3상 임상시험 결과가 포함되며, 이 약물이 고콜레스테롤혈증 치료에 얼마나 효과적인지에 초점을 맞춥니다.
주요 발표에서는 오비세트라립과 에제티미브의 고정 용량 병용 요법이 LDL-C 감소에 미치는 영향과 고심혈관 위험 환자에서의 약물 안전성 프로필을 강조할 것입니다. 추가 세션에서는 오비세트라립이 동맥경화, 혈관 염증에 미치는 영향과 중간 용량 스타틴과 병용 시 효과에 대해 다룰 예정입니다.
2025년 5월 4일부터 7일까지 예정된 이번 총회에서는 후기 발표, 포스터 네트워킹 세션, 워크숍 등 다양한 세션에서 여러 발표가 진행됩니다. 연구 결과는 기존 치료에 잘 반응하지 않는 LDL-C 상승 환자들을 위한 혁신적이고 저용량 경구 치료제로서 오비세트라립의 잠재력을 보여줍니다.
NewAmsterdam Pharma présentera de nouvelles données cliniques et précliniques sur son médicament obicetrapib lors du 93e Congrès de la European Atherosclerosis Society à Glasgow. Les présentations incluront les résultats des essais de phase 3 BROADWAY et TANDEM, mettant l'accent sur l'efficacité du médicament dans le traitement de l'hypercholestérolémie.
Les présentations clés mettront en lumière la combinaison à dose fixe d'obicetrapib avec l'ézétimibe pour la réduction du LDL-C ainsi que le profil de sécurité du médicament chez les patients à haut risque cardiovasculaire. D'autres sessions aborderont l'impact d'obicetrapib sur l'athérosclérose, l'inflammation vasculaire et ses effets en association avec des statines à dose modérée.
Le congrès, prévu du 4 au 7 mai 2025, proposera plusieurs présentations lors de différentes sessions, incluant des communications orales late-breaker, des sessions de posters et des ateliers. Les recherches démontrent le potentiel d'obicetrapib en tant que thérapie orale innovante à faible dose pour les patients présentant un LDL-C élevé et ne répondant pas bien aux traitements existants.
NewAmsterdam Pharma wird neue klinische und präklinische Daten zu seinem Medikament obicetrapib auf dem 93. Kongress der European Atherosclerosis Society in Glasgow vorstellen. Die Präsentationen umfassen Ergebnisse der Phase-3-Studien BROADWAY und TANDEM, die sich auf die Wirksamkeit des Medikaments bei der Behandlung von Hypercholesterinämie konzentrieren.
Wichtige Präsentationen heben die Fixdosis-Kombination von obicetrapib mit Ezetimib zur LDL-C-Senkung sowie das Sicherheitsprofil des Medikaments bei Hochrisiko-Patienten hervor. Weitere Sitzungen behandeln die Auswirkungen von obicetrapib auf Atherosklerose, Gefäßentzündungen und die Effekte in Kombination mit moderaten Statin-Dosen.
Der Kongress, der vom 4. bis 7. Mai 2025 stattfindet, bietet zahlreiche Vorträge in verschiedenen Sitzungen, darunter Late-Breaker-Oralpräsentationen, Poster-Networking-Sessions und Workshops. Die Forschung zeigt das Potenzial von obicetrapib als neuartige, orale Niedrigdosis-Therapie für Patienten mit erhöhtem LDL-C, die auf bestehende Behandlungen schlecht ansprechen.
- Multiple Phase 3 clinical trial data presentations (BROADWAY and TANDEM) showcasing obicetrapib's efficacy
- Positive preclinical data showing obicetrapib reduces atherosclerosis and vascular inflammation
- Demonstrated efficacy of obicetrapib in combination with ezetimibe and moderate-dose statins
- Development of a novel oral, low-dose therapy targeting a significant market (hypercholesterolemia)
- Strong scientific validation with multiple presentations at major industry conference (EAS Congress)
- None.
Insights
NewAmsterdam will present new Phase 3 data for obicetrapib at EAS Congress, marking a significant milestone in their hypercholesterolemia drug development program.
NewAmsterdam Pharma (NAMS) has announced upcoming presentations of new Phase 3 clinical trial data for obicetrapib at the European Atherosclerosis Society Congress in May 2025. This represents a significant milestone in their clinical development program for this oral, non-statin medicine targeting patients with elevated LDL-C cholesterol.
The company secured two prestigious late-breaker oral presentation slots focused on their BROADWAY and TANDEM Phase 3 clinical trials. One presentation will focus on a fixed-dose combination of obicetrapib with ezetimibe for LDL-C reduction, while the other will address safety and efficacy in high cardiovascular risk patients.
Obicetrapib is a cholesteryl ester transfer protein (CETP) inhibitor, a drug class that has historically seen mixed development results. These Phase 3 results are particularly important for establishing obicetrapib's profile in the lipid-lowering therapeutic landscape.
Beyond the late-breaker presentations, the company is presenting additional research on obicetrapib's mechanism of action, effects on reverse cholesterol transport, impact on lipophilic antioxidants, and efficacy when combined with moderate-dose statins. This comprehensive research program suggests NewAmsterdam is thoroughly characterizing the drug's effects and potential applications.
Hypercholesterolemia represents a significant market opportunity, with millions of patients not achieving adequate LDL-C control with current therapies. The scheduled presentations indicate progress in NewAmsterdam's development program, though the actual clinical outcomes from these trials will be the crucial factors determining obicetrapib's potential medical impact.
Phase 3 obicetrapib presentations at EAS highlight NewAmsterdam's advanced-stage clinical program for hypercholesterolemia treatment.
NewAmsterdam's upcoming presentations at the European Atherosclerosis Society Congress represent significant progress in their obicetrapib clinical development program, with two Phase 3 trials (BROADWAY and TANDEM) featured in late-breaker oral presentations.
From a clinical research perspective, the focus on a fixed-dose combination of obicetrapib with ezetimibe is scientifically relevant. This approach potentially provides complementary mechanisms of action - CETP inhibition alongside ezetimibe's inhibition of intestinal cholesterol absorption - which could yield additive effects on LDL-C reduction.
The second late-breaker addressing safety and efficacy in high cardiovascular risk patients is particularly important given this is the primary target population for lipid-lowering therapies. Clinical outcomes in this high-risk group are crucial for determining obicetrapib's potential utility.
The additional presentations on mechanisms like reverse cholesterol transport, effects on lipophilic antioxidants, and HDL subfraction composition demonstrate comprehensive mechanistic studies beyond primary lipid endpoints. This thorough characterization may help differentiate obicetrapib from other lipid-lowering approaches.
The presentation on combination with moderate-dose statins addresses an important clinical scenario, as most patients requiring additional LDL-C reduction are already on statin therapy. While these presentations will provide valuable new data, the true clinical significance will depend on the magnitude of LDL-C reduction and safety profile shown in the actual data presentations in May.
Presentations include new data from BROADWAY and TANDEM Phase 3 clinical trials, demonstrating obicetrapib’s impact on key lipid and lipoprotein biomarkers
NAARDEN, the Netherlands and MIAMI, April 30, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced it will present new clinical and preclinical data highlighting the potential for obicetrapib as a novel, oral, low-dose therapy for hypercholesterolemia, at the European Atherosclerosis Society (EAS) 93rd Congress, taking place on May 4-7, 2025 in Glasgow, UK.
Late-breaker oral presentation details are as follows:
Title: Fixed-Dose Combination of Obicetrapib and Ezetimibe for LDL-C Reduction: A Phase 3 Randomized Trial
Session Name: Late Breaker Session: Clinical
Oral Presentation Date and Time: Wednesday, May 5, 2025, 12:00-12:15 PM BST (7:00-7:15 AM ET)
Location: William Harvey Hall
Title: Safety and Efficacy of Obicetrapib in Patients at High Cardiovascular Risk
Session Name: Late Breaker Session: Clinical
Oral Presentation Date and Time: Wednesday, May 5, 2025, 12:15-12:30 PM BST (7:15-7:30 AM ET)
Location: Will Harvey Hall
Additional session details are as follows:
Title: Obicetrapib Reduces Atherosclerosis and Vascular Inflammation, Mainly by Reducing Non-HDL Cholesterol, Improves Lesion Stability and Adds to the Beneficial Effects of Ezetimibe
Session Name: SaaG Session: Emerging Lipid-Lowering Strategies: Mechanisms, Pre-clinical Studies and Outcomes
Presentation Date and Time: Monday, May 5, 2025, 1:58-2:05 PM BST (8:58-9:05 AM ET)
Location: Station 7
Title: Obicetrapib Alone and in Combination with Ezetimibe Increases Reverse Cholesterol Transport and Does Not Affect VLDL Production
Session Name: SaaG Session: Emerging Lipid-Lowering Strategies: Mechanisms, Pre-clinical Studies and Outcomes
Presentation Date and Time: Monday, May 5, 2025, 2:05-2:12 PM BST (9:05-9:12 AM ET)
Location: Station 7
Title: Low-Dose Obicetrapib Significantly Increases Concentrations of Lipophilic Antioxidants, ApoE, and S1P in HDL Subfractions
Session Name: SaaG Session: Lipid Lowering Therapies and Advances in Vascular Therapeutics
Presentation Date and Time: Monday, May 5, 2025, 2:19-2:26 PM BST (9:19-9:26 AM ET)
Location: Station 4
Title: Obicetrapib Significantly Increases Plasma and High-Density Lipoprotein (HDL) Levels of Lipophilic Antioxidants
Session Name: SaaG Session: Lipoprotein Dynamics: HDL to Remnants
Presentation Date and Time: Monday, May 5, 2025, 3:17-3:24 PM BST (10:17-10:24 AM ET)
Location: Station 3
Title: Efficacy and Safety of Combination Obicetrapib with Moderate-Dose Statins
Session Name: Poster Networking Sessions
Presentation Date and Time: Monday, May 5 & Tuesday, May 6, 2025, 5:20 - 6:50 PM BST (12:17-1:24 PM ET)
Location: Poster Board #246, Exhibition Hall
Title: Safety and Efficacy of Cholesteryl Ester Transfer Protein Inhibition: From Genetics to Outcome Trials
Session Name: Workshop: New risk factors for atherosclerotic disease
Presentation Date and Time: Wednesday, May 7, 2025, 12:20 -12:30 PM BST (7:17-8:24 AM ET)
Location: James Black Hall
About NewAmsterdam
NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.
Company Contact
Matthew Philippe
P: 1-917-882-7512
matthew.philippe@newamsterdampharma.com
Media Contact
Spectrum Science on behalf of NewAmsterdam
Jaryd Leady
P: 1-856-803-7855
jleady@spectrumscience.com
Investor Contact
Precision AQ on behalf of NewAmsterdam
Austin Murtagh
P: 1-212-698-8696
austin.murtagh@precisionaq.com
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