NewAmsterdam's Obicetrapib Reduces Alzheimer's Biomarker p-tau217 In High-Risk ApoE4 Carriers, Supporting CETP Inhibition As Potential Preventive Approach

-- Pre-specified analysis shows obicetrapib significantly reduced absolute levels of plasma p-tau217, a key biomarker of Alzheimer's disease pathology, in both the full analysis set (p=0.0019) and in ApoE4 carriers (p=0.0215), supporting CETP inhibition as a potential novel, upstream approach to Alzheimer's prevention –

-- In 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 (p=0.010) --

-- 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 –

NAARDEN, the Netherlands and MIAMI, July 30, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (NASDAQ:NAMS), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease ("CVD") with elevated low-density lipoprotein cholesterol ("LDL-C"), for whom existing therapies are not sufficiently effective or well-tolerated, today announced full data from the prespecified Alzheimer's disease ("AD") biomarker analysis in the BROADWAY clinical trial (NCT05142722). 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 ("ASCVD") and/or heterozygous familial hypercholesterolemia ("HeFH"), 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 is both a risk factor for CVD and AD where ApoE4 carriers generally exhibit higher levels of LDL-C, Lp(a), and reduced cholesterol transport and clearance. Treatment with obicetrapib 10 mg daily for 12 months resulted in statistically significant lower absolute changes in plasma p-tau217, a key biomarker of AD pathology, in both the analysis set (p=0.0019) and in ApoE4 carriers (p=0.0215). Favorable trends were also observed across additional biomarkers, including neurofilament light chain ("NFL"), glial fibrillary acidic protein ("GFAP"), p-tau181, and the Aβ42/40 ratio, in the full analysis set and in ApoE4 carriers, with the greatest effect generally observed in carriers of two E4 proteins.