NewAmsterdam Pharma Presents Positive Data from BROADWAY Trial Demonstrating Statistically Significant Reductions in Key Alzheimer’s Disease Biomarkers at AAIC 2025

Core Insights - Obicetrapib significantly reduced plasma p-tau217 levels, a key Alzheimer's disease biomarker, in both the full analysis set and in ApoE4 carriers, indicating its potential as a novel approach to Alzheimer's prevention [1][3][12] - In ApoE4/E4 carriers, obicetrapib reduced p-tau217 levels by 20.5% over 12 months compared to placebo [1][4] - The results support obicetrapib's cardiometabolic profile, showing reductions in LDL-C and other cardiovascular risk factors [1][2] Company Overview - NewAmsterdam Pharma is a late-stage biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated LDL-C [1][15] - The company aims to address unmet needs in populations where existing therapies are not sufficiently effective or well-tolerated [15] Clinical Trial Details - The BROADWAY trial was a pivotal Phase 3 study designed to evaluate the LDL-C lowering efficacy of obicetrapib in patients with established atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia [2][10] - A total of 2,530 patients were randomized to receive either 10 mg obicetrapib or placebo for 52 weeks, with the primary endpoint being the percent change in LDL-C [10][11] Biomarker Analysis - The prespecified analysis evaluated the effect of obicetrapib on plasma biomarkers of Alzheimer's disease in 1,515 patients, including 367 ApoE4 carriers [2][12] - Statistically significant reductions in p-tau217 were observed, with additional favorable trends in other biomarkers such as NFL and GFAP [3][4][12] Implications for Alzheimer's Disease - The findings suggest that upstream lipid modulation may influence Alzheimer's disease risk, particularly in ApoE4 carriers, who represent over 25% of the population [7] - Obicetrapib's ability to reduce multiple important AD biomarkers alongside its LDL-C lowering effects highlights its potential to address both neurodegenerative and cardiovascular disease risks [7][14]