Guerbet see positive Phase III results for MRI agent
pharmafile | March 24, 2021 | News story | Research and Development |Â Â MRIÂ
Medical imaging company, Guerbet, have announced the success of its Phase III study into the safety and efficacy of Gadopiclenol, a high-relaxivity macrocyclic contrast agent used for magnetic resonance imaging (MRI).
A total of 560 patients participated in two studies in 60 hospitals spanning across 13 countries, exploring the use of Gadopiclenol which allows the dose of gadolinium during an MRI to be reduced by half, compared to products on the market.
The clinical trials compared Gadopiclenol with Gadobutrol, a no contrast agent, having indications covering the central nervous system and various other anatomical areas including the head and neck, thorax, abdomen, pelvis, and musculoskeletal system.
The study’s endpoints were met, proving the diagnostic benefit of injecting Gadopiclenol during MRI examinations and outperforming Gadobutrol for the visualisation and detection of lesions of the central nervous system and in the other anatomical areas studied.
David Hale, CEO of Guerbet, said: “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.”
In addition to these Phase III trials, a study was conducted on 80 children between the ages of 2 and 17 in centres across five European countries. This study showed that the pharmacokinetic profile of Gadopiclenol at 0.05mmol/kg in children was similar to that of adults, therefore showing it will be possible to extrapolate the efficacy of Gadopiclenol to the paediatric 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.
Guerbet is planning to make regulatory submissions early next year in a wide range of indications in adults and children from two years of age.
Kat Jenkins
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