Ligand Pharmaceuticals Incorporated announced positive top line results from a Phase 1 clinical trial of its internal Captisol-enabled (CE) Iohexol program. The CE-Iohexol program was established in January 2018 to develop a Captisol-enabled, next-generation contrast agent for diagnostic imaging with a reduced risk of renal toxicity. Based on top line data, the trial achieved the primary endpoint demonstrating pharmacokinetic bioequivalence between CE-Iohexol injection and a reference Iohexol injection (OMNIPAQUE™) after intravenous (IV) administration in healthy adults. CE-Iohexol injection was safe and well tolerated, and adverse events were in line with the known safety profile of OMNIPAQUE. Details and data from the Phase 1 trial have been submitted for presentation at future scientific conferences.
“Our team did an excellent job executing this trial ahead of schedule, and we are very encouraged by the top line results of this Phase 1 trial,” said John Higgins, Chief Executive Officer of Ligand. “We have confidence in the continued development of CE-Iohexol with the goal to advance it to additional studies to support a registration filing. After the full data is published later this year, we look forward to exploring potential commercial partnerships for this program.”
“This trial represents a promising milestone in the pursuit of a safer agent for patients who receive intravenous contrast for their radiology and cardiology tests and procedures,” said Peter A. McCullough, MD, MPH, Vice Chief of Medicine, Baylor University Medical Center, Dallas TX, and President, Cardiorenal Society of America. “Top line results showed that this unique product incorporating a patented formulation ingredient had the expected pharmacokinetic profile compared to the reference standard agent, yet it potentially offers less kidney injury when given in patients with baseline kidney disease, diabetes, and multiple associated risk factors.”