NewAmsterdam Pharma Reveals Positive Topline Data From BROADWAY Clinical Trial

(RTTNews) - NewAmsterdam Pharma Company N.V. (NAMS), a late-stage, clinical biopharmaceutical company, announced positive topline data from prespecified Alzheimer's Disease (AD) biomarker analyses in the Phase 3 BROADWAY clinical trial (NCT05142722).

The pivotal Phase 3 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.

The AD sub-study results from BROADWAY build on genetic, Mendelian randomization, and NewAmsterdam's pre-clinical data and data from its Phase 2a clinical proof of concept trial.

The pre-specified analyses show that obicetrapib treatment leads to statistically significant and clinically meaningful reductions in the primary outcome measure of Alzheimer's disease biomarker in both the full ITT population and in ApoE4 carriers, supporting the emerging link between CETP-inhibition and prevention of AD pathology.