Pilot Study Underway to Evaluate Neuroimmune Modulation Treatment for Multiple Sclerosis

SetPoint Medical has begun enrolling patients in a pilot clinical study evaluating the SetPoint System as a potential pro-remyelination therapy for adults living with relapsing-remitting multiple sclerosis (RRMS).

The multicenter, randomized study received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to evaluate SetPoint Medical’s proprietary neuroimmune modulation device. Additionally, the neuroimmune modulation device has received Breakthrough Device Designation and was accepted into the Total Product Life Cycle (TPCL) Advisory Program (TAP) by the FDA.

The primary purpose of this sham-controlled, double-blind pilot study is to assess the safety and remyelinating effects of the SetPoint System as an adjunct to standard-of-care disease-modifying therapy (DMT) in adults with RRMS. The SetPoint System contains a miniaturized neurostimulator that is surgically implanted on the left vagus nerve and delivers electric stimulation to the nerve for one minute, once daily. The study will enroll up to 60 U.S. participants, with primary outcomes assessed at one year.

The study has enrolled patients at Shepherd Center’s Andrew C. Carlos MS Institute in Atlanta, and UW Medicine Multiple Sclerosis Center in Seattle.  Other centers participating in the study include Minnesota Center for Multiple Sclerosis in Plymouth, Minn.; West Virginia University in Morgantown, W.V.; Johns Hopkins University in Baltimore; UT Medicine Multiple Sclerosis and Neuroimmunology Center in Austin, Texas; and University of Texas Health Science Center in Houston.

“Remyelination is one of the most critical yet unmet clinical needs in the treatment of multiple sclerosis,” said Jacqueline Rosenthal, M.D., medical director of the MS Institute and the study’s principal investigator at Shepherd Center, where the first patient was enrolled. “While current therapies focus largely on suppressing inflammation, restoring the damaged myelin sheath is essential for preserving neuronal function and preventing long-term disability. Neuroimmune modulation is hypothesized to recalibrate immune activity while supporting the conditions necessary for myelin repair, and offers an innovative avenue to evaluate whether meaningful remyelination can be achieved in patients living with MS.”

Multiple sclerosis affects nearly 1 million U.S. residents and is an autoimmune disorder that damages the myelin sheath—the protective layer surrounding nerve fibers—disrupting signals between the brain and other parts of the body.

“Reaching this milestone of implanting the first patients in this RRMS pilot study is a meaningful step forward for us,” SetPoint Medical Chief Medical Officer David Chernoff, M.D., stated. “Our approach to activating the body’s innate neuroimmune pathways offers a compelling and novel mechanism that could complement current standards of care for multiple sclerosis. We are grateful to the investigators and patients participating in this study.”

The SetPoint System is used to treat adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response, or intolerance to one or more biological or targeted synthetic disease-modifying antirheumatic drugs. Using the SetPoint System for treating multiple sclerosis is not approved, is considered investigational, and its safety and effectiveness for this indication have not been established.

SetPoint Medical is a commercial-stage medical technology company striving to improve care for chronic autoimmune disease sufferers. The company’s FDA-approved SetPoint System is the first neuroimmune modulation therapy available for rheumatoid arthritis (RA) patients, offering a device-based alternative for those who do not respond to or cannot tolerate biologic or targeted drug therapies. SetPoint’s proprietary integrated neurostimulation platform is designed to activate innate anti-inflammatory pathways in the vagus nerve to reduce inflammation and restore immunologic setpoint. SetPoint is also planning to evaluate its platform technology for other conditions, including multiple sclerosis and Crohn’s disease.