US-based Boomerang’s device was granted breakthrough device designation by the US Food and Drug Administration (FDA) in March 2023. Image credit: Shutterstock/SewCreamStudio.

Boomerang Medical has completed stage two enrolment of a pilot study investigating the use of its bioelectronic technology to treat inflammatory bowel disease (IBD).

Boomerang Medical said the BOOM-IBD clinical trial (NCT05414955) has successfully enrolled patients with Crohn’s disease or ulcerative colitis – the two most common forms of IBD. The trial is recruiting across eight clinical sites in the US.

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As per a ClinicalTrials.gov entry, Boomerang has not outlined the therapy regimen in stage two of the study. Patients with IBD will be “treated with neuromodulation at various intervals”, according to the entry.

The single-group, open-label clinical trial is estimated to enrol 40 adult patients with diagnosed Crohn’s disease or ulcerative colitis. Boomerang stated that, unlike typical IBD studies, BOOM-IBD allows patients to be recruited who may not have already tried biologic therapy. The trial enrolled its first patient in April 2023.

US-based Boomerang’s device was granted breakthrough device designation by the US Food and Drug Administration (FDA) in March 2023. The technology uses sacral nerve stimulation to reduce inflammation and improve symptoms. The neurostimulator is implanted in a minimally invasive procedure.

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Sacral nerve stimulation devices have already been approved by the FDA to treat overactive bladder and chronic faecal incontinence. The first came in 1997 when Medtronic’s Interstim system gained approval to treat urge incontinence.

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It is estimated that more than half a million people in the US have Crohn’s disease. More than three-quarters of a million are estimated to be living with ulcerative colitis.

Medical device approaches to treatment also include stimulating the vagus nerve stimulation. Within the pharma industry, there is a plethora of options that target inflammation. The landscape has seen a significant shift in recent years with the arrival of Humira (adalimumab) biosimilars and high-profile drug approvals, including an expanded approval for AbbVie’s Rinvoq (upadacitinib) and approval for Pfizer’s Velsipity (etrasimod).

Dr Christian Stone, the principal investigator at one of the sites, said: “This study represents a promising step forward in the quest for expanding the armamentarium for managing IBD.”