NewAmsterdam Pharma has reported encouraging topline data from a prespecified Alzheimer’s biomarker data analysis in the double-blind, multi-centre pivotal Phase III BROADWAY trial of obicetrapib.
This sub-study specifically examined the impact of obicetrapib on Alzheimer’s plasma biomarkers in the complete trial subjects and in those who carry the apolipoprotein E 4 (APOE4) gene.
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The primary aim of the registration BROADWAY study was to assess the efficacy of this oral therapy in reducing low-density lipoprotein cholesterol (LDL-C) among adults with established atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH).
These individuals do not have adequately controlled LDL-C despite being on maximally tolerated lipid-lowering therapy.
The therapy claims to have enhanced the progression of key plasma biomarkers of the disease’s pathology over 12 months in those with ASCVD.
The global, 52-week, double-blind, randomised, and placebo-controlled trial involved sites across Asia, Europe, Australia, and North America.
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By GlobalDataIt assessed a 10mg dose of the therapy against a placebo as an adjunct to maximally tolerated lipid-lowering treatments in this patient population.
A total of 2,530 subjects were randomised and given either 10mg of the therapy or a placebo daily for 52 weeks with/without food.
Despite the majority of subjects being on high-intensity statin therapy, the mean baseline LDL-C was around 100mg/dL in the therapy arm.
According to the company, the primary endpoint is the least squares mean per cent from baseline in LDL-C of the 10mg dose of the therapy against placebo post-84 days. This showed a 33% decrease with imputation.
Secondary goals included percentage changes in various lipid parameters.
The low-dose cholesteryl ester transfer protein (CETP) inhibitor obicetrapib is being developed by the company to address the limitations of present LDL-lowering treatments.
NewAmsterdam Pharma CEO Michael Davidson said: “In this study, obicetrapib, a potent CETP inhibitor, improved the progression of key plasma biomarkers of Alzheimer’s 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 the progression of Alzheimer’s, alongside the significant cardiovascular benefits obicetrapib has shown in our pivotal Phase III trials.”
In previous Phase II and III trials, obicetrapib demonstrated LDL-C reductions with a side effect profile comparable to placebo.
Last year, the company announced a win in the first of its four Phase III pivotal trials, showing obicetrapib can decrease cholesterol levels.
