NewAmsterdam Pharma pany N.V.(US:NAMS) Globenewswireยท2025-06-09 11:00Core Insights - NewAmsterdam Pharma announced positive topline data from the Phase 3 BROADWAY clinical trial, indicating that obicetrapib treatment leads to significant reductions in Alzheimer's disease biomarkers in both the full population and ApoE4 carriers [1][2][3] Group 1: Clinical Trial Details - The BROADWAY study was designed to evaluate the LDL-C lowering efficacy of obicetrapib in patients with established atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) [2][4] - The trial involved 2,530 patients randomized to receive either 10 mg obicetrapib or placebo for 52 weeks, with a mean baseline LDL-C of approximately 100 mg/dL [4][5] - The primary endpoint showed a 33% reduction in LDL-C after 84 days for the obicetrapib group compared to placebo [6] Group 2: Alzheimer's Disease Sub-Study - A pre-specified sub-study assessed the effects of obicetrapib on plasma biomarkers of Alzheimer's disease, including p-tau217, in 1,727 patients, with significant results in both the full population (p<0.002) and ApoE4 carriers (p=0.0215) [7] - The sub-study aimed to evaluate the impact of a 12-month therapy duration on AD biomarkers, indicating a potential to alter disease trajectory in ApoE4 carriers [3][7] Group 3: Implications and Future Plans - The findings suggest a potential preventive strategy for Alzheimer's disease, particularly for the 25% of the population carrying ApoE4 risk alleles [3] - NewAmsterdam plans to present full results from the AD sub-study at the Alzheimer's Association International Conference in July 2025 [1][3] Group 4: About Obicetrapib - Obicetrapib is a novel, oral, low-dose CETP inhibitor developed to address limitations of current LDL-lowering treatments, showing significant LDL-lowering effects in multiple trials [9][10] - The company has also initiated the Phase 3 PREVAIL cardiovascular outcomes trial, which has enrolled over 9,500 patients [9]