SetPoint Medical, a biotech company developing therapies for inflammatory bowel diseases (IBD), announced that it is now evaluating safety and efficacy for its novel treatment for Crohn’s disease. The announcement was made by the gastroenterologists responsible for the trial at the annual “Advances in Inflammatory Bowel Diseases” clinical and research conference hosted by the Crohn’s & Colitis Foundation in Orlando, Florida.
The Valencia, California-based company will conduct the trial with patients suffering from moderately-to-severely active Crohn’s despite treatment with a tumor necrosis factor (TNF) antagonist drug, and it will be held at five different research centers in Europe. The investigators will stimulate the patients’ vagus nerve with an implanted device in order to activate the natural inflammatory reflex of the body, and induce the production of the systemic anti-inflammatory effect.
“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” explained the coordinating investigator for the study, Geert D’Haens, who is a Professor of Gastroenterology at The University of Amsterdam’s Academic Medical Center (AMC). “SetPoint’s approach has shown encouraging results in patients with rheumatoid arthritisand we look forward to evaluating its potential in Crohn’s patients in this important new study.”
The novel platform being tested by SetPoint as a treatment for Crohn’s disease is an implantable miniature neuromodulation device that includes a wireless charger and iPad app. It is able to stimulate the body’s vagus nerve and, as a result, create a potent, systemic, anti-inflammatory effect. SetPoint had also previously demonstrated positive results of the technology in a first-in-human, open-label, proof-of-concept trial in rheumatoid arthritis, revealing its clinical efficacy when compared to immunosuppressive drugs, as presented at the American College of Rheumatology annual meeting in November 2012.
“We are very encouraged by the positive results of our study in rheumatoid arthritis using this breakthrough approach to treating autoimmune and inflammatory diseases,” added the chief executive officer of SetPoint Medical, Anthony Arnold. “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 has been dedicated to creating an innovative platform for bioelectronic medicine that helps in the treatment of a variety of inflammation-mediated autoimmune diseases. The company believes that by using bioeletronic medicine, it will be able to substitute and improve therapeutics that were previously administered with drugs. Therefore, SetPoint aims to target those conditions with advanced implantable devices instead of drugs, providing more treatment advantages.
“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 focused on developing new treatments for Crohn’s and look forward to seeing the results of this trial.”
Investigation in the field of bioelectronic medicine has gained attention and support from different organizations, including the DARPA ElectRx NIH SPARC and GlaxoSmithKline Bioelectronics Innovation Challenge programs. In addition, SetPoint currently has major investors for the conduction of the trial companies such as Morgenthaler Ventures Foundation Medical Partners Topspin Partners Covidien Ventures Action Potential Venture Capital Limited the GlaxoSmithKline (GSK).