A pioneering new MS treatment which targets neuroimmune pathways will be the focus of a landmark study in the US next year following a breakthrough for its developer.
And yesterday it announced that it has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA), meaning it can now test its platform in people living with relapsing-remitting MS.
A multi-centre, randomised, double-blind, sham-controlled pilot study will be initiated next year and will enroll up to 60 patients across the United States.
MS is an autoimmune disorder that damages the myelin sheath, which is the protective layer that surrounds and insulates nerve fibers. This disrupts signals to and from the brain, causing neurodegeneration and a cascade of debilitating symptoms, such as visual impairment, difficulty walking, sensory disturbance, pain, cognitive difficulty, and fatigue.
There is currently no cure for MS, and while the currently approved medicines can help slow down disease progression and, in some instances, ease some of the symptoms, there are no approved treatments that work on reversing the root cause of MS – damage to the myelin sheath.
David Chernoff, chief medical officer of SetPoint Medical, said: “We look forward to initiating this pilot study to advance SetPoint’s platform in another therapeutic area.
“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.”
The SetPoint System includes an implantable, rechargeable neurostimulation device that electrically stimulates the vagus nerve once daily to activate innate anti-inflammatory and immune-restorative pathways.
After placement during an outpatient procedure, it is programmed to deliver scheduled therapy once daily. The device was also granted Breakthrough Device Designation and accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot in March 2024 for the treatment of relapsing-remitting multiple sclerosis (RRMS).
