MILAN, Feb. 6, 2025 /PRNewswire/ -- Bracco Imaging, a global leader in diagnostic imaging, announced today that the U.S. FDA has granted Fast Track designation for the development of BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection for detecting areas of active bowel inflammation in patients with Crohn's disease.

BR55 is a novel molecular imaging ultrasound contrast agent designed to specifically target the vascular endothelial growth factor receptor 2 (VEGFR2), a molecule highly expressed by endothelial cells in areas of angiogenesis, thus enhancing the ultrasound signal in areas with high angiogenesis activity.

The FDA designation follows the successful completion of Phase 2 studies, showing more than 95% accuracy of BR55-enhanced ultrasound imaging at detecting the expression of VEGFR2 in breast, ovarian, and thyroid cancer tissues, as well as in bowel segments showing active inflammation in patients with Crohn's disease.

Crohn's disease is a chronic, relapsing inflammatory disease of the gastrointestinal tract, in which angiogenesis and chronic inflammation are codependent, i.e., inflammation promotes angiogenesis, and the growth of new vessels enhances tissue inflammation, so that disease activity correlates with the extent of neovascularization.i,ii,iii,iv,v,vi

Recent clinical evidence has shown that, even in the absence of clinical symptoms, persistence of active inflammation can result in progressive bowel damage, serious complications and disability. Therefore, proactive monitoring of disease activity is of paramount importance for proper patient management.vii Detection of angiogenesis with molecular imaging, using a widely available, portable, noninvasive, radiation-free imaging modality like ultrasound, may emerge as a powerful tool to monitor the effectiveness of treatment used to control inflammation and disease activity in patients with Crohn's disease, especially now that new drugs and biologics are being developed, or have already been introduced in clinical practice.viii,ix,x,xi

"The FDA Fast Track process is designed to facilitate development and expedite the review of important new therapeutics and medical imaging agents.xii 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," said Alberto Spinazzi, MD, Chief Medical and Regulatory Officer, Bracco Imaging Group. "This Fast Track designation supports our goal to get BR55 to the patient earlier and more efficiently."

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