NewAmsterdam Pharma announces topline data from BROADWAY clinical trial

NewAmsterdam Pharma (NAMS) announced topline data from prespecified Alzheimer’s Disease biomarker analyses in the Phase 3 BROADWAY clinical trial. The pivotal Phase 3 BROADWAY study was primarily designed to evaluate the low-density lipoprotein cholesterol lowering efficacy of obicetrapib 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. As part of this pivotal registration trial for lowering LDL-C, a pre-specified sub-study was conducted to assess the effect of obicetrapib on plasma biomarkers of AD in both the full study population and in patients carrying the ApoE4 gene. The Company plans to present the full results from the AD sub-study analysis in a Developing Topics oral presentation at the Alzheimer’s Association International Conference in Toronto at the end of July 2025. “These findings strongly support a potential preventive strategy for Alzheimer’s disease,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. “In this study obicetrapib, a potent CETP inhibitor, improved the progression of key plasma biomarkers of AD pathology over a 12-month period in patients with ASCVD. These data further differentiate obicetrapib and underscore the critical role CETP inhibition may have in mitigating the risk of AD progression, alongside the significant cardiovascular benefits obicetrapib has shown in our pivotal Phase 3 trials.”