お知らせ • Jul 02
NewAmsterdam Pharma Presents Data On Obicetrapib For Alzheimer’s Disease Prevention At AAIC 2026
NewAmsterdam Pharma Company N.V. announced that it will present data highlighting the potential for obicetrapib as a novel, oral, low-dose therapy for the prevention of early Alzheimer’s disease, at the Alzheimer's Association International Conference (AAIC) 2026, taking place on July 12 – 15, 2026 in London, United Kingdom. Presentation details are as follows: Title: Predictors of P-tau217 in Cardiovascular Patients: Insights from the Broadway Trial; Abstract ID Number: 2026-A-6102-AAIC; Session Title: 2-17-FRS-A Featured Research Sessions: Alzheimer’s Therapy: Mechanisms Beyond Amyloid; Oral Presentation Date and Time: Monday, July 13, 2026 at 9:30 AM BST; Location: George V 1/2. Title: Undiagnosed Alzheimer’s Pathology in Cardiovascular Patients and its Implications for Prevention: BROADWAY Trial Dissected; Abstract ID Number: 2026-A-5998-AAIC; Poster Number: 0057; Session Title: In-Person Posters: Drug Development; Poster Presentation Date and Time: Tuesday, July 14, 2026 at 7:30 AM – 4:30 PM BST; Location: ICC Maritime Hall. Title: ApoE4-Dependent Dose Response to CETP Inhibition: A Responder Analysis Informing Alzheimer’s Prevention Trial Enrichment Strategies; Abstract ID Number: 2026-A-8875-AAIC; Poster Number: 0435; Session Title: In-Person Posters: Biomarkers: Biomarkers (non-neuroimaging); Poster Presentation Date and Time: Tuesday, July 14, 2026 at 7:30 AM – 4:30 PM BST; Location: ICC Maritime Hall. Title: CETP Inhibition for Alzheimer’s Prevention: Obicetrapib’s Multi-Pathway Effects on Lipid Mediated Pathophysiology; Abstract ID Number: 2026-A-5685-AAIC; Poster Number: 0056; Session Title: In-Person Posters: Human Drug Development; Poster Presentation Date and Time: Wednesday, July 15, 2026 at 7:30 AM – 4:30 PM BST; Location: ICC Maritime Hall. Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company’s Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of MACE. The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, international pharmaceutical and diagnostics company. In BROADWAY, a pre-specified analysis was designed to assess plasma biomarkers of Alzheimer’s disease (“AD”) in patients enrolled in the BROADWAY trial and evaluated the effects of longer duration of therapy (12 months) with a prespecified ApoE population, based on phenotypic analysis. The analysis included 1,535 patients, including 367 ApoE4 carriers (ApoE3/E4 or ApoE4/E4), whose ApoE status was able to be determined. Because this analysis was based on a subset of patients from BROADWAY (which was designed to evaluate LDL-C reductions in an ASCVD and/or HeFH population), the AD analysis was not controlled for baseline differences between the treatment and placebo populations, but statistical analyses were adjusted for baseline biomarker values and age. The absolute and percent change over 12 months in p-tau217, a key biomarker of AD pathology, was measured among patients with baseline and end of study datapoints above the lower limit of quantitation. Additional outcome measures included NFL, GFAP, p-tau181, and Aß42/40 ratio absolute and percent change over 12 months. NewAmsterdam observed statistically significant lower absolute changes in p-tau217 compared to placebo over 12 months in both the full analysis set (p=0.025; n= 1,535) and in ApoE4 carriers (p=0.022; n=367) as well as favorable trends in the other AD biomarkers. Although a safety analysis was not performed in the AD analysis population, in BROADWAY obicetrapib was observed to be well-tolerated, with safety results comparable to placebo.