NewAmsterdam Pharma said it has dosed the first participant in Spinoza, a phase 2b trial of obicetrapib in preclinical Alzheimer’s disease, and is planning to enroll about 400 adults ages 55 to 85.
The study will randomize participants 1:1 to obicetrapib 10 mg or placebo for 52 weeks, with a 26-week open-label extension available afterward. The primary endpoint is the change in plasma p-tau217 from baseline to week 52. Secondary measures include Aβ42/Aβ40, p-tau217/Aβ42, p-tau217/Aβ42/40, bd-tau and the Preclinical Alzheimer’s Cognitive Composite 5 score.
The trial’s design builds on the company’s Broadway biomarker analysis, which included 1,535 patients and 367 APOE4 carriers. In that analysis, NewAmsterdam said obicetrapib showed statistically significant lower absolute changes in p-tau217 versus placebo over 12 months in the full set, with p=0.025, and in APOE4 carriers, with p=0.022.
Spinoza is also being run alongside NewAmsterdam’s other late-stage studies of obicetrapib, including Rembrandt, Rubens and Prevail. The company said Prevail has completed enrollment and randomized more than 9,500 patients. The market has reacted to these announcements by moving the company's shares 4.43% to a price of $23.58. For more information, read the company's full 8-K submission here.
