US-based biomedical technology firm SetPoint Medical has initiated a pilot trial to evaluate its bioelectronic device for the treatment of refractory rheumatoid arthritis (RA) in adults.
SetPoint is developing the vagus nerve stimulation device as a miniaturised, rechargeable, wireless and implantable option for the disease.
It comes without any external battery or wires and can be removed based on requirement.
The randomised, multi-centre study will investigate the safety, efficacy and tolerability of the device in 15 subjects aged 22 to 75 years, who failed to achieve an adequate response to various biologic agents.
During the study, which will be conducted at seven US sites, the device will be surgically implanted on the vagus nerve to provide electrical doses according to a preset schedule.
Study principal investigator Mark Genovese said: “Despite the effectiveness of biologic and targeted agents for the treatment of rheumatoid arthritis, many patients either do not respond, lose therapeutic response or are intolerant to these agents.
“There remains a real need to develop alternative therapeutic approaches for the treatment of patients with drug refractory disease.
“Bioelectronic medicine represents a novel and promising approach for patients who need other options for treatment of their rheumatoid arthritis.”
In a prior proof-of-concept study, a modified commercial neuromodulation device is reported to have demonstrated a clinically meaningful decrease in disease activity score (DAS28) in more than 50% of the RA patients.
Furthermore, five out of seven subjects who previously failed to respond to different biologic agents have reportedly achieved significant DAS28 responses.
Based on these findings, the investigators concluded that active electrical vagus nerve stimulation can block TNF production and diminish disease severity in patients suffering from RA.