NewAmsterdam Pharma Partners with AI Firm Caristo Diagnostics for Innovative Cholesterol Drug Trial

NewAmsterdam Pharma has announced a partnership with UK-based artificial intelligence company Caristo Diagnostics for its upcoming phase 3 Rembrandt Cardiovascular Imaging trial. The study will evaluate the efficacy of NewAmsterdam's cholesterol-lowering drug candidate, a fixed-dose combination of obicetrapib and ezetimibe, in reducing the risk of adverse cardiovascular events.

AI-Powered Imaging Technology to Assess Drug Efficacy

Caristo Diagnostics will play a crucial role in the trial by overseeing global imaging across 50 sites in seven countries. The company's AI-powered platforms, CaRi-Heart and CaRi-Plaque, will be used to evaluate the drug combination's impact on coronary plaque burden and inflammation, both considered major drivers of strokes and heart attacks.

The CaRi-Heart platform utilizes an advanced AI algorithm to quantify inflammation on coronary computed tomography angiography (CCTA) scans. This technology can detect early signs of heart disease that are often invisible to the naked eye, using a Fat Attenuation Index (FAI) score to measure inflammation in fat surrounding the coronary arteries.

Additionally, the CaRi-Plaque platform will measure changes in noncalcified coronary atherosclerotic plaque volume, which may indicate potential beneficial effects on atherosclerotic cardiovascular disease (ASCVD) events.

Comprehensive Trial Support and Future Outlook

Under the agreement, Caristo will provide extensive support for the Rembrandt trial, including:

• Certifying and training all trial sites
• Conducting baseline and follow-up analyses for all randomized patients at 6 and 18 months
• Ensuring image quality control, data anonymization, and radiation dose optimization

Dr. John Kastelein, co-founder and Chief Scientific Officer of NewAmsterdam, emphasized the importance of the Rembrandt trial in the company's clinical development program for obicetrapib.

This partnership comes as NewAmsterdam pursues regulatory approval for obicetrapib based on positive Phase 3 results showing lowered low-density lipoprotein cholesterol (LDL-C) levels. The company is also conducting the Prevail trial, studying cardiovascular outcomes in nearly 10,000 patients with a history of atherosclerotic cardiovascular disease, with results expected in late 2026.

As NewAmsterdam aims for a potential major adverse cardiovascular event (MACE) label for obicetrapib, this collaboration with Caristo Diagnostics represents a significant step in leveraging cutting-edge AI technology to advance cardiovascular drug development and patient care.