Ligand Pharmaceuticals Incorporated announced completion of enrollment of the Company’s Phase 1 clinical trial of its internal Captisol-enabled (CE) Iohexol program. The CE-Iohexol program is designed to develop a Captisol-enabled, next-generation contrast agent for diagnostic imaging with a reduced risk of renal toxicity.
Contrast agents are used to enhance diagnostic imaging. Despite their benefits and widespread use, contrast agents may place patients at an increased risk for acute kidney injury (AKI), especially those with certain risk factors undergoing cardiac interventional procedures utilizing intravascular iodinated contrast.
CE-Iohexol is designed to reduce the risk of AKI during imaging procedures where iodinated contrast agents are administered.
In animal models CE-Iohexol has been shown to prevent nephrotoxicity by more than 50%.
More than 30 million imaging procedures are performed each year in the U.S. Iodinated contrast agents represent more than 60% of all X-ray imaging agents sold with an annual U.S. market of approximately $1.5 billion. Iohexol, the most widely-used injectable diagnostic contrast agent for imaging procedures, has global sales exceeding $500 million3.
Contrast-induced acute kidney injury (CI-AKI) is the acute impairment of renal function following intravascular administration of an iodinated contrast agent, and occurs most frequently following coronary angiography, percutaneous coronary intervention and contrast-enhanced computed tomography, especially among patients at risk of renal injury such as those with advanced age, diabetes or heart failure. CI-AKI is an issue with broad medical visibility as more than 50% of cardiovascular imaging procedures are performed in patients age 65 or older.
Currently no products are approved to prevent or treat CI-AKI in this setting, and therefore a significant opportunity exists for a safer formulation. The goal is for CE-Iohexol to establish a new safety standard that enables a future partner to gain meaningful market share.