GSK-backed SetPoint unveils clinical data for bioelectronic Crohn's treatment

GlaxoSmithKline-backed SetPoint Medical presented promising data from a study assessing its bioelectronic treatment for Crohn’s disease, just one of the various inflammatory diseases the company is targeting with its bioelectronic medicine platform.

The open-label pilot study is currently being conducted at 5 sites in Europe, according to a statement. It is using a bioelectronic implant to stimulate the vagus nerve in patients with moderately to severely active Crohn’s disease despite being treated with a tumor necrosis factor (TNF) antagonist. The treatment works by delivering electrical pulses to the vagus nerve and triggering the body’s inflammatory reflex to tamp down on inflammation.

Eight patients received a bioelectronic implant in the neck, SetPoint said in the statement. At 16 weeks post-implantation, their symptoms were assessed using the Crohn’s Disease Activity Index (CDAI). A CDAI score higher than 450 indicates severe Crohn’s. Six of the patients’ scores were cut by at least 70 points, while three of them reached endoscopic remission, or the normalization of their bowel lining as seen using an endoscope.

“The treatment was well tolerated and significantly reduced Crohn’s symptoms in six of eight patients. We are evaluating a new cohort of patients as the study continues,” said Dr. Geert D’Haens, a professor of gastroenterology at the University of Amsterdam’s Academic Medical Center, in the statement.

There is currently no cure for Crohn’s disease. Steroids and immunosuppressants are used to delay progression of the disease, but patients who do not see success with drugs may require surgery. “Patients living with Crohn’s need alternatives to existing treatments that often do not work well and carry significant risks, and modulating the inflammatory reflex shows promise as a new option to fight this debilitating disease using digital doses,” said SetPoint CEO Anthony Arnold in the statement.

GlaxoSmithKline is betting big on the emerging field of bioelectronic devices, also known as electroceuticals. Bioelectronics is based on using implantable devices to stimulate the body’s own impulses to heal itself from disease. The devices, which are envisioned to effect biochemical changes in the body typically brought on by drugs, could be used in combination with drugs or replace them altogether. The British pharma set up R&D ops for electroceuticals in 2012, and debuted its $50 million venture fund in 2013. SetPoint’s platform, which targets the body’s inflammatory reflex, is just one of the multiple early-stage electroceuticals the pharma is funding.