Neurostimulator to repair myelin in RRMS named breakthrough device

FDA status supports work on potential treatment, trial in patients possible

Patricia Inacio, PhD avatar

by Patricia Inacio, PhD |

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The U.S. Food and Drug Administration has designated SetPoint Medical’s neurostimulator a breakthrough device for the treatment of relapsing-remitting multiple sclerosis (RRMS).

This designation is intended to accelerate the development of devices intending to more effectively treat or diagnose life-threatening or chronically debilitating diseases than standard approaches.

It was supported by evidence showing that SetPoint’s nerve stimulator platform may slow myelin damage and promote its repair, an unmeet need in multiple sclerosis (MS) and other demyelinating conditions. The company now is planning to work with the regulatory agency to open a clinical trial of the therapeutic device in RRMS patients.

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“This significant milestone highlights the platform potential of SetPoint’s device and therapeutic approach for the treatment of multiple chronic conditions,” Murthy V. Simhambhatla, PhD, CEO of SetPoint Medical, said in a company press release.

“As next steps, we look forward to working collaboratively with the FDA to initiate the first-of-its-kind clinical trial to investigate our device for people living with RRMS,” Simhambhatla added.

MS is caused by an erroneous immune response against components of the myelin sheath, a fatty substance that warps around nerve fibers to help them transmit nerve signals more efficiently. This results in myelin loss (demyelination) and nerve cell damage, ultimately leading to a range of disease symptoms.

While over 20 disease-modifying therapies now are approved to treat relapsing MS forms, these mostly work by reducing the inflammatory attacks that drive the disease, and have little to no ability to repair myelin.

“These drugs do not completely stop the development of new lesions, nor do they promote repair (remyelination) of existing lesions and damaged tissue,” said Shiv Saidha, a professor of neurology at Johns Hopkins University.

“There is an urgent unmet medical need for therapies that can promote protection and functional restoration of damaged axons through remyelination in patients, and SetPoint’s therapeutic approach could offer new hope to people living with this chronic debilitating condition,” Saidha added.

Device placed near vagus nerve in neck to trigger inflammatory reflex pathway

SetPoint’s device is believed to address this need by stimulating the vagus nerve, the longest nerve in the body that runs from the brain to multiple organs and controls such functions as digestion, heart rate, and breathing.

The vagus nerve also can detect and respond to inflammatory signals, triggering a pathway called the inflammatory reflex that reduces excessive inflammatory signals and restores balance to the immune system.

SetPoint reports that its researchers discovered the precise nerve fibers involved in the inflammatory reflex, and the specific stimulation parameters needed to activate this pathway.

The device is a small nerve stimulator, roughly the size of an oral capsule, that is designed to be implanted in the neck’s region of the vagus nerve through a small incision done during an outpatient procedure.

The implant has a battery that can be recharged with a wireless charger, and its electrical pulses can be adjusted for precision by physicians using an iPad application.

A number of proof-of-concept studies have demonstrated the device’s safety and effectiveness at reducing immune responses in people with rheumatoid arthritis and inflammatory bowel diseases, SetPoint reports.

An ongoing and pivotal Phase 3 trial (NCT04539964) may support a request for the device’s approval to treat adults with rheumatoid arthritis, a disease caused by immune system attacks on joints and other tissues.