Caristo Diagnostics, which uses artificial intelligence to detect the earliest signs of heart disease on cardiac CT scans, will play a major role in an upcoming study of NewAmsterdam Pharma’s cholesterol-lowering drug candidate obicetrapib.
U.K.-based Caristo will oversee global imaging for NewAmsterdam’s Rembrandt Cardiovascular Imaging trial.
The phase 3 trial, which spans 50 sites in seven countries, will study whether New Amsterdam’s obicetrapib and ezetimibe fixed-dose combination can lower the risk of adverse cardiovascular events like heart attack and stroke. Obicetrapib is New Amsterdam’s investigational CETP inhibitor while ezetimibe is an older cholesterol drug sold under the brand name Zetia.
Specifically, NewAmsterdam will use Caristo’s AI-powered CaRi-Heart and CaRi-Plaque technology to evaluate the efficacy of the combination drug on coronary plaque burden and inflammation, both considered major drivers of strokes and heart attacks.
Although coronary inflammation, a precursor to artery-blocking plaque buildup, is one of the earliest predictors of major cardiac events, it is invisible to the naked eye on routine CCTA (coronary computed tomography angiography) scans, according to Caristo.
The company’s CaRi-Heart platform uses an advanced AI algorithm to quantify inflammation on these scans, using its FAI (Fat Attenuation Index) score, a measure of inflammation in fat surrounding the coronary arteries.
The study will also use Caristo’s CaRi-Plaque platform to measure changes in noncalcified coronary atherosclerotic plaque volume. Favorable changes “may indicate a potential beneficial effect on atherosclerotic cardiovascular disease (ASCVD) events,” according to the press release.
“The Rembrandt trial and evaluation of the effects of obicetrapib on coronary plaque and inflammation metrics is an important part of New Amsterdam’s clinical development program,” NewAmsterdam co-founder and Chief Scientific Officer John Kastelein said in the release. “We are delighted to have Caristo as a partner on our journey.”
Under the agreement, Caristo will certify and train all trial sites, conduct baseline and follow-up analyses for all randomized patients at 6 and 18 months, and ensure image quality control, data anonymization and radiation dose optimization.
Financial terms were not disclosed.
This comes as NewAmsterdam pursues regulatory approval for obicetrapib based on Phase 3 readouts showing it lowered low-density lipoprotein cholesterol (LDL-C).
Another trial, Prevail, is studying cardiovascular outcomes of almost 10,000 patients with a history of atherosclerotic cardiovascular disease. That study is on track to wrap up in late 2026, as the biotech eyes a potential MACE (major adverse cardiovascular event) label for obicetrapib.
