SetPoint Medical, a biomedical technology company developing a bioelectronic medicine therapy for inflammatory diseases, announced the start of clinical testing to assess safety and efficacy in Crohn’s Disease, a debilitating disease caused by inflammation in the digestive tract. The trial launched as gastroenterologists gather this week in Orlando, Florida for “Advances in Inflammatory Bowel Diseases,” the Crohn’s & Colitis Foundation’s annual clinical and research conference.

“Despite recent advances in therapy for Crohn’s, most patients do not achieve full disease control, and many who are adequately controlled seek alternatives to standard drug treatments,” said Dr. Geert D'Haens, Professor of Gastroenterology at The Academic Medical Center (AMC), University of Amsterdam and Coordinating Investigator for the study. “SetPoint’s approach has shown encouraging results in patients with rheumatoid arthritis, and we look forward to evaluating its potential in Crohn’s patients in this important new study.”

The proof-of-concept study is being conducted at five centres in Europe, and will include patients with moderately-to-severely active Crohn’s despite treatment with a tumor necrosis factor (TNF) antagonist drug. The trial will use an implanted device to stimulate the vagus nerve, activating the body’s natural Inflammatory Reflex to produce a systemic anti-inflammatory effect.

“We are very encouraged by the positive results of our study in rheumatoid arthritis using this breakthrough approach to treating autoimmune and inflammatory diseases,” said Anthony Arnold, chief executive officer of SetPoint Medical. “We are pleased to launch this new study, which we anticipate will provide further evidence that our approach can have benefits for both patients and caregivers and will reduce healthcare costs.”

SetPoint is developing a novel proprietary bioelectronic medicine platform to treat a variety of inflammation-mediated autoimmune diseases. The emerging field of bioelectronic medicine aims to target disorders historically treated with drugs, instead using advanced implantable devices offering significant advantages. Research in this field is being driven forward by support from several recently announced funding initiatives including the DARPA ElectRx, NIH SPARC, and GlaxoSmithKline Bioelectronics Innovation Challenge programmes.

“Millions of people worldwide are living and suffering with Crohn’s disease, which causes abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition,” said Marjorie Merrick, vice president of research special projects at the Crohn's & Colitis Foundation of America. “Current treatments include medication, dietary changes and sometimes surgery, but there is no standard treatment that will work for all patients, and the need for new approaches and new treatment options is great and urgent. We applaud all efforts focussed on developing new treatments for Crohn’s and look forward to seeing the results of this trial.”