Bracco Imaging has received fast-track designation from the U.S. Food and Drug Administration (FDA) for development of the company’s BR55 imaging agent 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 biomarker for Crohn’s disease. An injection consists of perfluorobutane/nitrogen lipopeptide-coated microbubbles.
The FDA designation follows the successful completion of phase II studies, where BR55 successfully detected 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.
Bracco is now advancing BR55 to prospective, controlled, large-scale phase III studies. These studies will evaluate the safety and efficacy of the imaging agent when used to detect angiogenesis and active inflammation in patients with Crohn’s disease.