SetPoint Medical’s open-label study supports the use of the company’s bioelectronic therapy for Crohn’s Disease. The Valencia,CA-based company’s study was conducted at five European sites and included 16 patients with moderate to severe Crohn’s Disease with inadequate responses to tumor necrosis factor (TNF) antagonist drugs and other non-TNF targeted biologic agents.
The data, presented in a poster session at the Digestive Disease Week meeting in Washington, D.C., showed that more than 60% of patients achieved significant reductions in their disease activity as assessed by the Crohn’s Disease Activity Index (CDAI).
Improvement was assessed at 16 weeks by measuring the change from baseline in the CDAI, a clinical trial measurement used to quantify disease activity. Severe Crohn’s is defined by a CDAI greater than 450. Reduction of 70 or more points on the CDAI scale is considered to be clinically meaningful, and remission is defined as a score below 150.
“These positive clinical trial results, especially in patients who have failed biologic therapy, are very encouraging for patients who are in desperate need of new treatment options for Crohn’s and other inflammatory diseases,” said David Chernoff, MD, CMO of SetPoint Medical, said in a release. “We saw improvements in the clinical scores and in biomarkers of disease activity within two weeks of therapeutic dosing and a significant clinical response at the 16-week endpoint. Based on these preliminary results, we will continue to evaluate our bioelectronic medicine approach for the treatment of Crohn’s Disease as we are also conducting an ongoing clinical study in rheumatoid arthritis.”
SetPoint’s device is about the size of a penny and stimulates the vagus nerve with digital doses of electricity designed to activate the cholinergic anti-inflammatory reflex to produce a systemic immunorestorative effect. The company has published positive results from a first-in-human proof-of-concept trial in rheumatoid arthritis in Proceedings of the National Academy of Sciences (PNAS).
SetPoint spoke with MD+DI in March and said it had launched U.S. clinical trials to advance its bioelectronic technology for chronic inflammatory conditions.