NewAmsterdam Pharma Company N.V. (NASDAQ:NAMS) on Monday released topline data from pre-specified Alzheimer’s Disease biomarker analyses in the Phase 3 BROADWAY clinical trial.
The study was primarily designed to evaluate the efficacy of obicetrapib in lowering low-density lipoprotein cholesterol (LDL-C) 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.
A pre-specified sub-study was conducted to assess the effect of obicetrapib on plasma biomarkers of Alzheimer’s in the full study population and patients carrying the ApoE4 gene.
Also Read: Why Is NewAmsterdam Pharma Stock Trading Higher On Tuesday?
The company plans to present the full results from the AD sub-study analysis in a Developing Topics oral presentation at the Alzheimer’s Association International Conference in Toronto at the end of July 2025.
The primary endpoint was the LS mean percent change from baseline in LDL-C of obicetrapib 10 mg compared to placebo after 84 days, which showed a 33% reduction with imputation.
Secondary endpoints also included percent changes from baseline of obicetrapib 10 mg compared to placebo in ApoB, Lp(a), ApoA1, HDL-C, non-HDL-C, total cholesterol, and triglycerides at day 84, and on LDL-C levels at days 180 and 365.
Other exploratory outcome measures included time from randomization until the first confirmed occurrence of MACE in the obicetrapib arm compared to the placebo.
The trial also evaluated the safety and tolerability profile of obicetrapib.
In a note to investors, the investment firm William Blair expressed continued confidence in NewAmsterdam Pharma’s drug, obicetrapib, following the release of new clinical trial data.
William Blair analyst Matt Phipps said, “We continue to believe obicetrapib will offer a differentiated product profile in the marketplace, and while we have not factored in Alzheimer’s benefit to our current assumptions, this could clearly provide significant long-term upside…we continue to believe seeing LDL reductions below 55% would be a positive for NewAmsterdam, particularly utilization of the fixed-dose-combination with ezetimibe.”
William Blair maintained an Outperform rating on NewAmsterdam Pharma, citing a 90% probability of success for obicetrapib. The analyst has derived a fair value for NewAmsterdam shares of $43.
Phipps asserted that obicetrapib could achieve a significant and clinically meaningful reduction in cardiovascular outcomes in the ongoing Phase 3 PREVAIL trial, potentially achieving a 20% or greater relative risk reduction.
Price Action: NAMS stock is trading lower by 1.04% to $19.93 at last check Monday.
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This article Analyst Says NewAmsterdam Stock Has Over 100% Upside, Citing 90% Success Probability For Obicetrapib originally appeared on Benzinga.com
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