Nerve stimulator for myelin repair to enter RRMS clinical trial
SetPoint device stimulating the vagus nerve could be tested in patients next year
SetPoint Medical is planning to launch a clinical trial next year to investigate its nerve stimulator device, intending to support myelin repair, in people with relapsing-remitting multiple sclerosis (RRMS).
The announcement comes after U.S. Food and Drug Administration (FDA) approval of an investigational device exemption, allowing the company to initiate clinical studies to collect safety and efficacy data on the device and its use, SetPoint reported in a company press release.
It also follows a Phase 3 trial of the device in people with rheumatoid arthritis, another autoimmune disease marked by damaging inflammation, that found clinical benefit with reasonable safety.
Aiming to enroll up to 60 RRMS patients at multiple sites in the U.S., the upcoming trial will randomly assign participants to treatment with the device or to a sham procedure. Assignment will be blinded, meaning neither patients nor their treating physicians will know who is receiving which procedure.
Neurostimulator might repair myelin sheath, an unmet need for MS patients
The device, which is believed to slow damage to the myelin sheath and promote its repair — an unmet need in demyelinating conditions such as multiple sclerosis (MS) — previously was designated a breakthrough device by the FDA in treating RRMS.
“We look forward to initiating this pilot study to advance SetPoint’s platform in another therapeutic area,” said David Chernoff, chief medical officer of SetPoint.
MS is due to inflammation in the brain and spinal cord that damages and destroys the myelin sheath, a fatty covering around nerve fibers that’s necessary for healthy nerve cell communication. This loss of myelin, or demyelination, results in a range of disease symptoms, from pain and fatigue to motor impairment and cognitive issues.
About 20 disease-modifying therapies are approved for relapsing forms of MS, which are marked by periods of MS flares during which symptoms suddenly worsen, followed by periods of remission in which symptoms ease. But the therapies all focus on modulating or suppressing the immune system to prevent or slow myelin damage. No approved therapy to date can repair the damage that has accrued.
Small device implanted in patients’ neck to allow for daily nerve stimulation
SetPoint’s device, the company reports, is designed to promote myelin repair (remyelination) by electrically stimulating the vagus nerve. This nerve, the longest in the body, runs from the brain to multiple organs to control essential functions like breathing, heart rate, and digestion.
The vagus nerve also can detect and respond to inflammatory signals, activating the inflammatory reflex pathway to dial down excessive inflammation and restore immune balance.
Company researchers report having identified the specific nerve fibers involved in this pathway, and the stimulation parameters needed to activate it. Biomarker analysis, SetPoint states on a webpage, also indicate that a single stimulation of the vagus nerve can control inflammation for more than 24 hours.
The rechargeable device is said to be about the size of an oral capsule and designed to be implanted in the neck, close to the vagus nerve, in an outpatient surgical procedure. Once implanted, it will be programmed to directly stimulate that nerve once a day.
Research in rat models of MS showed that vagus nerve stimulation significantly reduced immune cell activation in demyelinated regions and improved myelin repair, although best results in these animals were seen with continuous stimulation.
Top-line results of Phase 3 trial in rheumatoid arthritis show benefit
“The results from our studies in validated preclinical models of MS suggest that the SetPoint System has the potential to address the urgent unmet medical need for novel therapies that reduce demyelination and promote remyelination — providing new hope for people living with MS,” Chernoff said.
Earlier this year, the FDA brought SetPoint and its neurostimulator into its pilot Total Product Life Cycle Advisory Program, which aims to speed patient access to innovative devices by allowing more frequent communication with the regulatory agency.
SetPoint also recently announced positive top-line results from the RESET-RA Phase 3 study (NCT04539964) testing the safety and efficacy of its implanted device in people with moderate to severe rheumatoid arthritis. Patients were treated with vagus nerve stimulation for one minute each day for 12 weeks.
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