Ligand Pharmaceuticals, a US-based biopharmaceutical company recently announced positive top line results from clinical trial of its internal CE (Captisol-enabled) Iohexol program. The study attained primary endpoint indicating pharmacokinetic bioequivalence between OMNIPAQUE™ & Captisol-enabled Iohexol, cite sources.

For the record, Iohexol is a commonly used injectable diagnostic contrast agent for imaging procedures and has global sales that amount to more than $500 million with no generic competition in the U.S.

The Captisol-enabled Iohexol program was established in January 2018 to develop a next-gen contrast agent for diagnostic imaging that poses a decreased risk of renal toxicity. Based on data, the trial attained the primary endpoint indicating pharmacokinetic bioequivalence between OMNIPAQUE™, a reference Iohexol injection & CE-Iohexol injection after intravenous administration in healthy adults.

Captisol-enabled Iohexol injection was safe & well tolerated, adverse events were confined to established OMNIPAQUE safety profile. The details & data from the Phase 1 trial have been submitted for presentation at future scientific conferences.

John Higgins, CEO, Ligand, was reported to say that the Ligand team has executed the trial ahead of schedule. The company is looking forward to continuing development of Captisol-enabled Iohexol with the goal to advance it for additional studies to support a registration filing. He added, saying that after the data is published by the end of this year, the company has plans to explore potential commercial partnerships for this program.

Peter A. McCullough, President, Cardiorenal Society of America and MD, Vice Chief of Medicine, Baylor University Medical Center, Dallas, was reportedly quoted saying that this trial signifies a promising milestone that seeks safer agent for patients who are administered with intravenous contrast for their radiology & cardiology tests.

Top line results from the trial showed that this product which incorporates a patented formulation ingredient had the anticipated pharmacokinetic profile compared to the reference standard agent, and potentially offers less kidney injury when administered to patients with baseline kidney disease, diabetes, & multiple associated risk factors, McCullough added.

Source credits: https://investor.ligand.com/press-releases/detail/387/ligand-announces-positive-top-line-results-from-phase-1