The FDA granted Fast Track designation to a novel ultrasound contrast agent designed to detect active bowel inflammation in Crohn’s disease.
Summary:
The FDA has granted Fast Track designation to a novel ultrasound contrast agent developed by Bracco Imaging for detecting active bowel inflammation in Crohn’s disease. The agent targets vascular endothelial growth factor receptor 2 (VEGFR2), a key marker of angiogenesis linked to disease activity. Phase 2 studies demonstrated over 95% accuracy in identifying active inflammation, and the designation supports Bracco’s plan to advance the agent to large-scale phase 3 trials. The technology could provide a noninvasive, radiation-free imaging tool for monitoring Crohn’s disease and assessing treatment effectiveness.
Key Takeaways:
- FDA Grants Fast Track Status – The designation accelerates the development of an ultrasound contrast agent designed to detect active inflammation in Crohn’s disease.
- High Accuracy in Phase 2 Trials – The imaging agent demonstrated over 95% accuracy in identifying VEGFR2 expression in bowel inflammation, supporting its potential clinical use.
- Advancing to Phase 3 Studies – Bracco Imaging is preparing large-scale trials to evaluate the agent’s safety and efficacy in monitoring Crohn’s disease activity.
Bracco Imaging announced today that the US Food and Drug Administration (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 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.
The Role of Angiogenesis in Crohn’s Disease
Crohn’s disease is a chronic, relapsing inflammatory disease of the gastrointestinal tract, in which angiogenesis and chronic inflammation are codependent, ie, inflammation promotes angiogenesis, and the growth of new vessels enhances tissue inflammation, so that disease activity correlates with the extent of neovascularization.
Recent clinical evidence has shown that, even in the absence of clinical symptoms, the 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.
Detection of angiogenesis with molecular imaging, using a widely available, portable, noninvasive, radiation-free imaging modality like ultrasound, may emerge as a 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.
Advancing to Phase 3 Clinical Trials
“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,” says Alberto Spinazzi, MD, chief medical and regulatory officer at Bracco Imaging Group, in a release. “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,” says Fulvio Renoldi Bracco, CEO at Bracco Imaging Group, in a release. “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.”
