Neuroimmune Modulation Device Looks Promising for Rheumatoid Arthritis

Treatment with the SetPoint System, a neuroimmune modulation device, was associated with significant clinical benefit in adults with moderate to severe rheumatoid arthritis (RA), according to topline results from a phase 3 study.

The SetPoint System is a rechargeable neurostimulation device that is implanted on the vagus nerve through an outpatient procedure and is programmed to deliver therapy once daily on a preset schedule. The device is designed to activate innate anti-inflammatory and immune-restorative pathways by electrically stimulating the vagus nerve.

The landmark, 2-staged, randomized, sham-controlled, double-blind RESET-RA study (ClinicalTrials.gov Identifier: NCT04539964) evaluated the efficacy and safety of the SetPoint System in 242 adults with moderate to severe RA who have had an inadequate response, loss of response, or intolerance to biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs). Study participants were randomly assigned 1:1 to receive either the SetPoint System or control device (non-active stimulation) through a surgical procedure under general anesthesia in an outpatient setting.

Results showed a statistically significantly greater proportion of patients in the SetPoint System group achieved an American College of Rheumatology (ACR) 20 response (primary endpoint) at week 12 compared with the control group (P =.0209). The SetPoint System was found to be well tolerated with low rates of adverse events for both the implant procedure and the stimulation therapy. No safety concerns were observed in the first 12 weeks and during long-term follow-up.

“We are thrilled with the results from the RESET-RA study as they highlight the potential of the SetPoint System for providing rheumatologists and their patients with a safe and effective treatment alternative to current rheumatoid arthritis therapies,” said Murthy V. Simhambhatla, PhD, CEO of SetPoint Medical. “As next steps, we look forward to submitting the data for presentation at upcoming rheumatology and neurosurgical medical meetings, and completing our premarket approval submission to the FDA.”

The FDA previously granted Breakthrough Device designation to the SetPoint System for patients with moderate to severe RA with an incomplete response or intolerance to 1 or more biological DMARDs or targeted synthetic DMARDs.

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