NewAmsterdam Partners with Caristo Diagnostics for AI-Powered Cardiovascular Trial

NewAmsterdam Pharma has announced a strategic partnership with Caristo Diagnostics, leveraging artificial intelligence to enhance its upcoming cardiovascular drug trial. The collaboration aims to evaluate the efficacy of NewAmsterdam's cholesterol-lowering drug candidate, obicetrapib, in combination with ezetimibe.

AI-Driven Imaging in Cardiovascular Research

Caristo Diagnostics, a UK-based company specializing in AI-powered cardiac imaging analysis, will oversee global imaging for NewAmsterdam's Rembrandt Cardiovascular Imaging trial. The phase 3 study, spanning 50 sites across seven countries, will utilize Caristo's advanced AI algorithms to detect early signs of heart disease and assess the drug combination's impact on cardiovascular risk factors.

The trial will employ Caristo's CaRi-Heart and CaRi-Plaque technologies to evaluate coronary plaque burden and inflammation, both considered major drivers of strokes and heart attacks. CaRi-Heart's AI algorithm quantifies inflammation on coronary computed tomography angiography (CCTA) scans using the Fat Attenuation Index (FAI) score, a measure of inflammation in fat surrounding coronary arteries. Meanwhile, CaRi-Plaque will measure changes in noncalcified coronary atherosclerotic plaque volume.

Obicetrapib's Path to Approval

NewAmsterdam's obicetrapib, an investigational CETP inhibitor, is being studied in combination with ezetimibe, an established cholesterol medication. The company is pursuing regulatory approval for obicetrapib based on recent Phase 3 results demonstrating its ability to lower low-density lipoprotein cholesterol (LDL-C).

In addition to the Rembrandt trial, NewAmsterdam is conducting the Prevail study, a large-scale cardiovascular outcomes trial involving nearly 10,000 patients with a history of atherosclerotic cardiovascular disease. Set to conclude in late 2026, this study aims to support a potential major adverse cardiovascular event (MACE) label for obicetrapib.

Dr. John Kastelein, NewAmsterdam's co-founder and Chief Scientific Officer, emphasized the importance of the Rembrandt trial in the company's clinical development program, stating, "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 randomized patients at 6 and 18 months, and ensure image quality control, data anonymization, and radiation dose optimization. While financial terms of the partnership were not disclosed, the collaboration represents a significant step forward in the use of AI technology for cardiovascular drug development and evaluation.