NewAmsterdam Pharma has shared promising Alzheimer’s disease (AD) biomarker data from a late-stage study of its investigational oral cholesteryl ester transfer protein (CETP) inhibitor obicetrapib.
The 52-week phase 3 BROADWAY trial was primarily designed to assess the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of obicetrapib in adults with atherosclerotic cardiovascular disease (ASCVD), heterozygous familial hypercholesterolemia, or both, whose LDL-C was not adequately controlled despite being treated with maximally tolerated lipid-lowering therapy.
The company has already reported that the trial met its primary endpoint, with obicetrapib demonstrating a 33% reduction compared to placebo in LDL-C on top of maximally tolerated lipid modifying therapies at day 84.
However, results from a pre-specified AD sub-study showed that the candidate was also associated with statistically significant lower absolute changes in p-tau217, a biomarker for predicting cognitive decline, compared to placebo over 12 months in both the full BROADWAY population and in patients carrying the ApoE4 gene, a major risk factor for AD.
NewAmsterdam’s chief executive officer, Michael Davidson, said the findings “strongly support a potential preventive strategy for AD”.
He continued: “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.
“This data further differentiates obicetrapib and underscores 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.”
AD is the most common form of dementia, estimated to affect over seven million people in the US. The disease progressively destroys memory and thinking skills and, eventually, the ability to carry out simple tasks.
“Approximately two thirds of patients with AD carry the ApoE4 risk isoform that is associated with a much greater risk of developing AD, and the data shared… supports our belief that CETP inhibition and specifically raising small functional high-density lipoproteins particles offers a novel and targeted approach to reducing that risk,” said John Kastelein, NewAmsterdam’s chief scientific officer.
Full results from the AD sub-study are scheduled to be presented at this year’s Alzheimer’s Association International Conference at the end of July.