Systemic and Chronic

Imaging is critical in drug development for a broad range of systemic and chronic diseases. Fides brings a depth of expertise across imaging modalities and their application as a non-invasive  tool for early target validation and efficacy tracking across multiple diseases.

Fides has built standardised endpoints into its Aperis platform across a number of disease areas, and can rapidly implement bespoke endpoints and radiomic analysis to address complex scientific questions, particularly in the early stages of drug development. Our aim is to provide the highest possible level of treatment response characterisation to power early go/no go decision-making.

As a non-exhaustive list of systemic disease currently supported by Fides:

Metabolic Diseases: Imaging offers sensitive mechanism-linked biomarkers for use in early phase trials. Amongst the endpoints currently supported by FIdes, we number:

• Whole-body or regional DXA for total, lean and fat mass and fat distribution;
• MRI-Proton Density Fat Fraction (MRI-PDFF) and multiparametric MRI – used to assess ectopic fat deposition across multiple organs and tissue compartments to evaluate overall metabolic health;
• Body composition MRI – measuring visceral adipose tissue (VAT) volume, subcutaneous adipose tissue (SAT volume, total adipose tissue volume and skeletal muscle volume;
• MR Spectroscopy (MRS) – measuring hepatic triglyceride content, intramyocellular lipid content and myocardial lipid content

Bone Density and Bone Health: We offer a range of standard and novel endpoints for musculoskeletal disorders, including:

• DXA, the current regulatory standard, which includes multiple endpoints:
  • Bone Mineral Density (BMD)
  • T-score
  • Z-score
  • Percentage change from baseline
• Quantitative CT, which is used to measure volumetric BMD, trabecular bone density and cortical bone density, and which provides greater sensitivity that DXA in early phase studies.
• High-Resolution Peripheral Quantitative CT (HR-pQCT), measuring trabecular thickness, number and separation, along with cortical thickness and porosity;
• MRI Bone Biomarkers – making it possible to quantify bone marrow composition, marrow adiposity, bone perfusion and microstructural assessment.

Hepatology: A hotbed of imaging, with imaging often being used as a primary endpoint in Phase IIa MASH and MASHLD studies.Fides supports multiple endpoints in this therapy area, including:

• MRI-Proton Density Fat Fraction (MRI-PDFF), used to measure hepatic fat fraction and relative reduction in steatosis;
• Magnetic Resonance Elastography (MRE), which provides standardised measures of liver stiffness and fibrosis burden. MRE provides sensitive analysis of early fibrosis changes;
• Ultrasound-based Elastography: Includes FibroScan liver stiffness and Controlled Attenuation Parameter;
• Multiparametric MRI:
  • Corrected T1: providing measures of fibroinflammation and disease activity;
  • Iron-corrected T1: measuring inflammation, fibrosis and tissue injury

Fides’ expertise in measures of motility and organ movement enable us to layer assessments of organ function over standard endpoints, to deliver an holistic view of treatment response.