Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces 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. Ligand also provides below a summary of the findings of a survey of clinicians on radiocontrast agent selection and use.

“We are pleased to announce the progress of CE-Iohexol and look forward to reporting Phase 1 data later this year. This program holds the potential to increase the safety of widely-used commercial contrast agents, and, if successful, provide Ligand later-stage out-licensing opportunities,” said John Higgins, Chief Executive Officer of Ligand. “A key priority of Ligand’s business model is to conduct targeted R&D with the goal of advancing programs to secure significant financial terms upon out-license. Recent market research validates our view that there is a substantial unmet need for safer radiocontrast agents.”

Overview:

• 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.1
• 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%.2

Trial:

• The goal of the Phase 1 clinical trial is to establish pharmacokinetic bioequivalence to support subsequent clinical trials and to provide the basis for submitting a 505(b)(2) new drug application to the U.S. Food and Drug Administration.
• The trial design consists of a single-center, randomized, double-blind, two-period crossover study to determine relative bioavailability of CE-Iohexol and a reference Iohexol injection (OMNIPAQUE™) after IV administration in a population of 24 healthy adults (ClinicalTrials.gov identifier: NCT03869983).