NewAmsterdam Pharma (NASDAQ: NAMS) has announced positive topline data from the prespecified Alzheimer’s disease ("AD") biomarker analyses in the phase 3 Broadway clinical trial (NCT05142722). The trial, primarily designed to evaluate the low-density lipoprotein cholesterol ("LDL-C") lowering efficacy of obicetrapib in adult patients with established atherosclerotic cardiovascular disease ("ASCVD") and/or heterozygous familial hypercholesterolemia ("HeFH"), showed statistically significant and clinically meaningful reductions in the primary outcome measure of AD biomarker in both the full study population and in apoe4 carriers. This supports the emerging link between CETP-inhibition and prevention of AD pathology.
The pivotal phase 3 Broadway study evaluated the efficacy and safety of 10 mg obicetrapib compared to placebo as an adjunct to maximally tolerated lipid-lowering therapies in patients with ASCVD and/or HeFH whose LDL-C is not adequately controlled. The trial, conducted globally, randomized 2,530 patients 2:1 to receive obicetrapib or placebo dosed as a once-daily oral treatment for 52 weeks. The primary endpoint showed a reduction of 33% in LDL-C levels with obicetrapib compared to placebo after 84 days.
In the prespecified AD sub-study, which included 1727 patients, including 367 apoe4 carriers, obicetrapib showed lower absolute changes in p-tau217 compared to placebo over 12 months in both the full study population and in apoe4 carriers. These findings have significant implications for AD prevention, especially for the over 25% of the population that carries one or two apoe4 risk alleles and who currently lack FDA-approved prevention options.
The company plans to present the full results from the AD sub-study analysis at the Alzheimer’s Association International Conference in Toronto at the end of July 2025. Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments, and the company is investigating its potential as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.
NewAmsterdam Pharma is also conducting the phase 3 PREVAIL cardiovascular outcomes trial, designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events (MACE). The company has commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, which have been exclusively granted to the Menarini Group, an Italy-based leading international pharmaceutical and diagnostics company. Following these announcements, the company's shares moved 0.05%, and are now trading at a price of $20.15. For the full picture, make sure to review NewAmsterdam Pharma Co's 8-K report.
