NewAmsterdam Pharma presents data from BROADWAY trial at AAIC

NewAmsterdam Pharma (NAMS) announced full data from the prespecified Alzheimer’s disease biomarker analysis in the BROADWAY clinical trial. The data were presented today during a Developing Topics oral session at the 2025 Alzheimer’s Association International Conference, AAIC, in Toronto. The BROADWAY trial was primarily designed as a pivotal Phase 3 trial to evaluate LDL-C lowering efficacy of obicetrapib, a potent CETP inhibitor, in adult patients with established atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. In connection with this trial, a prespecified analysis evaluated the effect of obicetrapib on plasma biomarkers of AD in 1,515 patients with established ASCVD and/or HeFH whose ApoE status was able to be determined, including 367 ApoE4 carriers. Safety in this population was not evaluated independently from the overall BROADWAY study population, where obicetrapib was observed to be well-tolerated, with safety results comparable to placebo. APOE4/E4 carriers, the highest risk category for Alzheimer’s disease, obicetrapib reduced p-tau217 levels by 20.5%, over 12 months, compared to placebo. Results build on obicetrapib’s cardiometabolic profile, including multiple clinical trials demonstrating reductions in LDL-C, small dense LDL particles, Lipoprotein(a), and biomarkers associated with diabetes and kidney function .