Positive top-line Alzheimer’s disease data from NewAmsterdam

Dutch late-stage biotech NewAmsterdam Pharma (Nasdaq: NAMS) late yesterday announced positive top-line data from prespecified Alzheimer’s disease (AD) biomarker analyses in the Phase III BROADWAY clinical trial (NCT05142722). The firm’s US-traded shares were up 4.1% at $20.99 in pre-market activity this morning.

NewAmsterdam said the pivotal Phase III BROADWAY study was primarily designed to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of obicetrapib in adult patients with established atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH), whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. As part of this pivotal registration trial for lowering LDL-C, a pre-specified sub-study was conducted to assess the effect of obicetrapib on plasma biomarkers of AD in both the full study population and in patients carrying the ApoE4 gene.

“These findings strongly support a potential preventive strategy for Alzheimer's disease,” said Dr Michael Davidson, chief executive of NewAmsterdam, adding: “In this study obicetrapib, a potent CETP inhibitor, improved the progression of key plasma biomarkers of AD pathology over a 12-month period in patients with ASCVD. These data further differentiate obicetrapib and underscore the critical role CETP inhibition may have in mitigating the risk of AD progression, alongside the significant cardiovascular benefits obicetrapib has shown in our pivotal Phase III trials.”