NewAmsterdam Pharma announced positive topline data from prespecified Alzheimer’s Disease (AD) biomarker analyses within its Phase 3 BROADWAY clinical trial. The analyses showed that obicetrapib treatment led to statistically significant lower absolute changes in plasma p-tau217, a key AD biomarker, over a 12-month period.
The statistically significant reductions in p-tau217 were observed in both the full analysis set (p<0.002) and specifically in ApoE4 carriers (p=0.0215). These findings build upon existing genetic, Mendelian randomization, and preclinical data, supporting a potential link between CETP inhibition and the prevention of AD pathology.
These results suggest a potential preventive strategy for Alzheimer's disease, particularly for ApoE4 carriers who face a heightened risk and currently lack FDA-approved prevention options. This new indication significantly broadens the therapeutic potential and addressable market for obicetrapib.
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