Obicetrapib - (OCEAN)

Sept. 29, 2026: NewAmsterdam Pharma (NASDAQ: NAMS) announced the first participant was dosed in SPINOZA, a Phase 2b randomized, double-blind, placebo-controlled trial of obicetrapib in approximately 400 adults ages 55-85 with preclinical Alzheimer’s disease. Participants with biomarker evidence of early AD pathology and ApoE4/E4, ApoE3/E4, or ApoE3/E3 genotypes will receive obicetrapib 10 mg or placebo for 52 weeks, stratified by genotype, with an optional at least 26-week open-label extension.

The primary endpoint is change from baseline to Week 52 in plasma p-tau217. Secondary endpoints include changes in plasma AD biomarkers including Aβ42/Aβ40, p-tau217/Aβ42, p-tau217/Aβ42/40, BD-tau, and change in PACC5 cognitive score.

The trial design was informed by a prespecified Alzheimer’s biomarker analysis from the Phase 3 BROADWAY trial. In that analysis, obicetrapib showed statistically significant lower absolute changes in p-tau217 versus placebo over 12 months in the full analysis set (p=0.025; n=1,535) and in ApoE4 carriers (p=0.022; n=367), with favorable trends in other AD biomarkers. BROADWAY was not designed for AD and the subset analysis was adjusted for baseline biomarker values and age.