Newamsterdam Pharma Announced Topline Data From Prespecified Alzheimer's Disease Biomarker Analyses In The Phase 3 BROADWAY Trial Of Obicetrapib
Benzinga Newsdesk 1 year ago
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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
- 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 (p<0.002) and in ApoE4 carriers (p=0.0215), supporting the emerging link between CETP-inhibition and prevention of AD pathology.
- NewAmsterdam to present results during the AAIC conference in July.
- 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.