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

Core Insights - NewAmsterdam Pharma's 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][13] - In ApoE4/E4 carriers, obicetrapib reduced p-tau217 levels by 20.5% over 12 months compared to placebo [1][4][5] - The results support obicetrapib's cardiometabolic profile, showing reductions in LDL-C and other cardiovascular risk factors [1][2][15] 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][16] - The company aims to address unmet needs in populations where current therapies are inadequate or poorly tolerated [16] - Obicetrapib is being evaluated in multiple clinical trials, including the pivotal Phase 3 BROADWAY trial, which assesses its efficacy and safety in patients with established atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia [2][10][15] Clinical Trial Insights - The BROADWAY trial included 2,530 patients and was designed to evaluate the LDL-C lowering efficacy of obicetrapib [2][10] - A prespecified analysis of the trial assessed the effects of obicetrapib on plasma biomarkers of Alzheimer's disease in 1,515 patients, including 367 ApoE4 carriers [2][13] - The primary outcome measure was the absolute and percent change in p-tau217 over 12 months, with significant reductions observed [3][13] Biomarker Analysis - Statistically significant reductions in p-tau217 levels were observed in both the full analysis set and ApoE4 carriers, with p-values of 0.0019 and 0.0215, respectively [1][3][13] - Additional favorable trends were noted across other biomarkers, including NFL, GFAP, and p-tau181 [3][4][6] - The analysis highlights the potential of obicetrapib to influence Alzheimer's disease risk through lipid modulation, particularly in high-risk ApoE4 carriers [7][13] Future Directions - NewAmsterdam plans to discuss the results with regulatory authorities to determine potential next steps for obicetrapib [7][18] - The company is also exploring the commercialization rights of obicetrapib in Europe, which have been granted to the Menarini Group [15][16]