Bracco Imaging Receives FDA Fast Track Designation for BR55

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MILAN - February 6, 2025 -- 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."

i Jackson JR, Seed MP, Kircher CH, Willoughby DA, Winkler JD. The codependence of angiogenesis and chronic inflammation. FASEB J 1997; 11:457-465ii Costa C, Incio J, Soares R. Angiogenesis, and chronic inflammation: cause or consequence? Angiogenesis 2007; 10:149-166iii Halin C, Detmar M. Chapter 1. Inflammation, angiogenesis, and lymphangiogenesis. Methods Enzymol 2008; 445:1-25iv Pousa ID, Maté J, Gisbert JP. Angiogenesis in inflammatory bowel disease. Eur J Clin Invest 2008; 38:73-81v Knod JL, Crawford K, Dusing M, Collins MH, Chernoguz A, Frischer JS. Angiogenesis and Vascular Endothelial Growth Factor-A Expression Associated with Inflammation in Pediatric Crohn's Disease. J Gastrointest Surg 2016; 20:624-630vi Scaldaferri F, Vetrano S, Sans M, Arena V, Straface G, Stigliano E, Repici A, Sturm A, Malesci A, Panes J, Yla-Herttuala S, Fiocchi C, Danese S. VEGF-A links angiogenesis and inflammation in inflammatory bowel disease pathogenesis. Gastroenterology 2009; 136:585‑95.e5vii Dolinger M, Torres J, Vermeire S. Crohn's disease. Lancet 2024; 403:1177-1191.viii Chidlow JH Jr, Shukla D, Grisham MB, Kevil CG. Pathogenic angiogenesis in IBD and experimental colitis: new ideas and therapeutic avenues. Am J Physiol Gastrointest Liver Physiol 2007; 293:G5-G18ix Matsuno H, Yudoh K, Uzuki M, Nakazawa F, Sawai T, Yamaguchi N, Olsen BR, Kimura T. Treatment with the angiogenesis inhibitor endostatin: a novel therapy in rheumatoid arthritis. J Rheumatol 2002; 29:890-895x Nijhawan P, Behl T. The Role of Endostatin in Rheumatoid Arthritis. Curr Rheumatol Rev 2021; 17:68-75xi Danese S, Sans M, de la Motte C, Graziani C, West G, Phillips MH, Pola R, Rutella S, Willis J, Gasbarrini A, Fiocchi C. Angiogenesis as a novel component of inflammatory bowel disease pathogenesis. Gastroenterology 2006; 130:2060-2073xii U.S. Food and Drug Administration. Fast Track. Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track. Accessed January 27, 2025.

Source: Bracco Imaging

Posted : 2025-02-10 06:00

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