Bracco Imaging Receives FDA Fast Track Designation for BR55, Ultrasound Molecular Imaging Agent for the Detection of Active Bowel Inflammation in Crohn's Disease

• BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the detection of active bowel inflammation in patients with Crohn's disease.
• BR55 is a contrast agent for ultrasound imaging targeted at a molecule expressed in angiogenesis, i.e., the vascular endothelial growth factor receptor type 2, or VEGFR2.
• Phase 2 studies have provided satisfactory safety results and a high accuracy of BR55-enhanced ultrasound imaging at marking the expression of VEGFR2 in patients with breast, ovarian, and thyroid cancer, as well as in patients with Crohn's disease.
• The safety and efficacy of BR55 when used for the detection of areas of active bowel inflammation in patients with Crohn's disease is going to be evaluated in large-scale, multicenter, multinational adequate and well-controlled Phase 3 studies.

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."

Bracco Imaging is now advancing to prospective, controlled, large-scale Phase 3 studies aimed at evaluating the safety and efficacy of BR55 when used not only to detect angiogenesis but also active inflammation in patients with Crohn's disease. 

"Today's milestone is a result of our deep commitment to innovation that advances precision imaging technologies," said Fulvio Renoldi Bracco, CEO, Bracco Imaging Group. "As a leader in diagnostic imaging, Bracco will continue to invest in promising approaches, such as the science of microbubble technology, which enhances the contrast in ultrasound and shows great potential for additional targeted applications."

About BR55
BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) injection is an investigational ultrasound contrast agent designed to bind to VEGFR2, a protein that plays a central role in angiogenesis and inflammatory processes. By targeting VEGFR2, BR55 enables real-time, non-invasive imaging of areas of angiogenesis, offering the potential for earlier and more accurate assessment of active inflammation in conditions like Crohn's disease. This precision imaging approach may significantly enhance clinicians' ability to diagnose and monitor disease activity, guiding better treatment decisions.

About Bracco Imaging
Bracco Imaging is a global leader in diagnostic imaging, providing advanced imaging agents and state-of-the-art delivery systems across a wide range of modalities, including X-ray, MRI, Nuclear Medicine, and Ultrasound. With a legacy of innovation and a commitment to improving patient outcomes, Bracco continues to pioneer technologies that enhance diagnostic accuracy and transform patient care.

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Press Contact:
Carolina Bargoni
Bracco Imaging, Communications Director
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SOURCE Bracco Group