NewAmsterdam’s Alzheimer’s breakthrough shows promise

NETHERLANDS – NewAmsterdam Pharma has announced promising late-stage Alzheimer’s disease data from its Phase 3 BROADWAY clinical trial, highlighting obicetrapib’s potential role in prevention.

Originally designed to lower LDL-C in patients with cardiovascular disease, the investigational drug obicetrapib has now shown potential in slowing key Alzheimer’s biomarkers—an exciting development for neurodegenerative research.

The Alzheimer’s sub-study within BROADWAY analyzed the effects of obicetrapib on plasma biomarkers associated with Alzheimer’s disease, particularly in patients carrying the ApoE4 gene, which significantly increases the risk of developing the condition.

The results demonstrated statistically significant reductions in p-tau217—one of the key markers of Alzheimer’s pathology—over a 12-month treatment period.

“These findings strongly support a potential preventive strategy for Alzheimer’s disease,” said Michael Davidson, CEO of NewAmsterdam Pharma.

“Obicetrapib, a potent CETP inhibitor, improved the progression of key plasma biomarkers of AD pathology in patients with cardiovascular disease, showing that CETP inhibition may play a role in mitigating Alzheimer’s risk, alongside its significant cardiovascular benefits.”

The importance of these findings extends beyond conventional Alzheimer’s treatments, particularly for individuals carrying the ApoE4 gene, who currently lack FDA-approved preventive options.

“The ability to reduce pathological biomarker progression suggests a potential to alter disease trajectory,” explained Philip Scheltens, professor emeritus at Amsterdam University Medical Center.

“For the over 25% of the population that carries one or two ApoE4 risk alleles, this breakthrough could be a meaningful step toward delaying or even preventing Alzheimer’s symptoms.”

Obicetrapib has been extensively studied in cardiovascular treatment, but its potential impact on neurodegeneration is rapidly gaining attention.

“These results are the culmination of over two decades of scientific research,” said John Kastelein, Chief Scientific Officer of NewAmsterdam.

“Approximately two-thirds of Alzheimer’s patients carry the ApoE4 risk isoform, and our data suggest that CETP inhibition—specifically raising small functional HDL particles—offers a novel, targeted approach to reducing that risk.”

With a well-established safety profile across multiple large clinical trials and its simple oral administration, obicetrapib could offer a convenient and impactful option in Alzheimer’s prevention.

NewAmsterdam Pharma plans to present the full results at the Alzheimer’s Association International Conference in Toronto in July 2025, marking a significant milestone in Alzheimer’s research and drug development.