Clinical imaging in anti-atherosclerosis drug development

Area of Science:

• Cardiovascular Medicine and Pharmacology
• Medical Imaging in Clinical Trials

Background:

• Developing novel atherosclerosis drugs is hindered by large, expensive outcome trials.
• Lack of predictive biochemical biomarkers necessitates alternative endpoints for early-stage drug evaluation.

Purpose of the Study:

• To review the application and operational aspects of clinical imaging methods in interventional atherosclerosis trials.
• To highlight the utility of imaging data as intermediate Phase II endpoints for assessing drug efficacy.

Main Methods:

• Review of established and emerging clinical imaging modalities: Magnetic Resonance Imaging (MRI), Computed Tomography (CT), Ultrasound (Intima-Media Thickness [IMT], Intravascular Ultrasound [IVUS]), and Positron Emission Tomography (PET).
• Focus on imaging endpoints for assessing vascular plaque volume, morphology, and functional changes within the vessel wall.

Main Results:

• Clinical imaging offers detailed insights into vascular plaque characteristics, serving as valuable surrogate endpoints.
• These imaging endpoints can demonstrate mechanistic and anti-atherosclerotic activity, supporting risk mitigation for drug development.

Conclusions:

• Clinical imaging techniques are essential tools for interventional atherosclerosis trials, providing critical data for early-stage drug assessment.
• Utilizing imaging endpoints can streamline drug development, reducing reliance on costly late-stage outcome trials.