NewAmsterdam announces initial date from Phase 2a trial of obicetrapib

NewAmsterdam Pharma Company announced initial data from its Phase 2a clinical trial evaluating obicetrapib in patients with early Alzheimer’s disease (“AD”) and at least one copy of the apolipoprotein E4 mutation. This Phase 2a trial was designed to explore the effects of obicetrapib on lipid metabolism in the brains of early AD patients who are ApoE4 carriers. Two key biomarkers measured in the trial include 24- and 27-hydroxycholesterol; increases in these oxysterols over time have been observed to lead to a rise in cognitive and related functional impairment. As such, NewAmsterdam believes reductions of 24- and 27-hydroxycholesterol in the CSF may indicate improved cholesterol metabolism in the brain and may lead to improved cognitive function. In addition, the Phase 2a trial assessed the Abeta42/40 ratio and plasma pTau181, also believed to be biomarkers of AD, with lower levels of Abeta42/40 and increased levels of pTau181 having been associated with a greater risk of AD. This trial builds on observations from NewAmsterdam’s preclinical studies and third-party genetic studies that inhibiting cholesteryl ester transfer protein may protect against ApoE4-associated AD risk by preventing the accumulation of amyloid plaque in the brain through improved cholesterol metabolism and, as a result, potentially slow disease progression. Initial Data from the Phase 2a Alzheimer’s Trial: NewAmsterdam observed reductions in the levels of 24- and 27-hydroxycholestrol of 11% and 12%, respectively, in the CSF. In addition, an increase of 8% in the Abeta42/40 ratio in patient’s plasma was observed and pTau181 levels were observed to be stable. Overall, obicetrapib was observed to be well-tolerated. No serious adverse events were reported, nor were any AEs considered to be related to the study drug.