The US Food and Drug Administration (FDA) has granted fast track designation for the development of Bracco Imaging’s molecular imaging ultrasound contrast agent, BR55, to identify active bowel inflammation areas in Crohn’s disease patients.
Engineered to specifically act on the vascular endothelial growth factor receptor 2 (VEGFR2), BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection claims to improve the ultrasound signal.
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Bracco Imaging Group chief medical and regulatory officer Alberto Spinazzi said: “The FDA fast track process is designed to facilitate development and expedite the review of important new therapeutics and medical imaging agents.
“It is aimed at improving the management of patients with serious conditions and filling an unmet medical need, such as the accurate monitoring of disease activity in patients with Crohn’s disease. This fast track designation supports our goal to get BR55 to the patient earlier and more efficiently.”
The designation comes after the completed Phase II studies, which demonstrated BR55-improved ultrasound imaging accuracy of over 95% in VEGFR2 expression detection in various cancer tissues.
The recent clinical findings have also highlighted the critical need for diligent monitoring of Crohn’s disease, as ongoing inflammation can lead to severe complications.
The use of BR55 in ultrasound imaging presents a radiation-free, non-invasive method to assess treatment ‘effectiveness’.
The company is currently preparing for controlled, prospective, large-scale Phase III trials to further assess the efficacy and safety of the agent in identifying both angiogenesis and active inflammation in individuals with Crohn’s disease.
In December 2024, Bracco Imaging’s US unit, Bracco Diagnostics, and German medical device company ulrich received 510(k) clearance from the FDA for the Max 3, a rapid exchange and syringeless injector for MRI procedures.
