March 24, 2021 — Guerbet announced positive results from two Phase III clinical studies comparing the diagnostic efficacy and safety of Gadopiclenol to Gadobutrol in a wide range of indications, covering the central nervous system and various other anatomical areas (head and neck, thorax, abdomen, pelvis, musculoskeletal system).
A total of 560 patients were recruited for these two studies in over 60 hospital medical imaging departments in 13 countries.
The endpoints were met in terms of the diagnostic benefit of injecting Gadopiclenol (0.05 mmol/kg) during MRI examinations, based on: 1/ the superiority of the examination with Gadopiclenol compared to the examination with no contrast agent; and 2/ the non-inferiority of Gadopiclenol (0.05 mmol/kg) compared to Gadobutrol (0.1 mmol/kg) for the visualization and detection of lesions of the central nervous system and in the other anatomical areas studied.
In addition to these Phase III trials, a study was conducted on 80 children between 2 and 17 years of age in 19 centers in five European countries. This study showed that the pharmacokinetic profile of Gadopiclenol at 0.05 mmol/kg in children was similar to that of adults. It will therefore be possible to extrapolate the efficacy of Gadopiclenol to the pediatric population based on data collected in adult patients.
No major safety signals were reported during the development of Gadopiclenol, and the adverse reactions reported during the two Phase III studies were similar for both of the products administered.
"We are very happy with the results of these studies, which demonstrate the diagnostic value and good tolerance of Gadopiclenol during an MRI examination in adults and children. By using a lower dose of gadolinium in clinical practice, we hope this macrocyclic contrast agent will become a 'best-in-class' diagnostic solution for doctors and their patients." said David Hale, CEO of Guerbet.
All this data will serve as a basis for regulatory submissions, which will begin in the United States and in the European Union (EU) early 2022.
For more information: www.guerbet.com