Key takeaways
- Obicetrapib 10 mg significantly reduced plasma p-tau217 levels over 12 months in both the full analysis set and ApoE4 carriers, suggesting potential to slow Alzheimer’s disease progression.
- The BROADWAY sub-study enrolled over 1,700 participants, including 367 ApoE4 carriers, offering robust data on neurodegenerative biomarker trends within a cardiovascular trial population.
- These Alzheimer’s biomarker findings complement obicetrapib’s LDL-C lowering profile, supporting further evaluation of CETP inhibition for dual cardiovascular and neuroprotective benefit.
NewAmsterdam Pharma has shared positive data from the Phase III BROADWAY clinical trial (NCT05142722) evaluating the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of obicetrapib, a CETP inhibitor. In a prespecified Alzheimer’s disease biomarker analysis, obicetrapib demonstrated a significantly significant reduction in absolute levels of plasma p-tau217, a key biomarker of Alzheimer’s pathology.1
p-tau217 levels decline in overall and ApoE4 patient groups
Further findings from this readout show:
- Daily treatment with obicetrapib 10 mg for 12 months led to a statistically significant reduction in plasma p-tau217 levels in both the overall analysis set (p=0.0019) and in ApoE4 carriers (p=0.0215).
- In APoE4/E4 carriers, the highest risk category for Alzheimer’s, obicetrapib lowered p-tau217 levels by 20.5% over 12 months, compared to placebo.
- Additional biomarkers, including neurofilament light chain, glial fibrillary acidic protein, p-tau181, and the Aβ42/40 ratio, also showed favorable trends.
- The most pronounced effects were observed in individuals with two copies of the ApoE4 allele.
ApoE4 is a known risk factor for both cardiovascular and Alzheimer’s disease, often associated with higher LDL-C, elevated Lp(a), and impaired cholesterol transport.
In a press release, Michael Davidson, MD, chief xecutive officer of NewAmsterdam Pharma, said: “Alzheimer’s disease remains a devastating global health challenge, with no effective preventive treatments available. Obicetrapib, our investigational once-daily oral therapy, shows promise by significantly slowing the progression of, and in some instances decreasing, plasma levels of p-tau217, a key Alzheimer’s biomarker, in this analysis. This is especially important in ApoE4 gene carriers—a group that represents over a quarter of the population and faces a heightened risk for this disease. Combined with its LDL-C lowering benefits observed in multiple clinical trials, obicetrapib may offer a unique opportunity to reduce both neurodegenerative and heart disease risks.”
