Bioelectronic device improves rheumatoid arthritis symptoms in first-in-human trial

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A trio of collaborators announced Monday clinical trial data showing that an implantable neuromodulation device improved symptoms of rheumatoid arthritis. The results may also have an impact on patients with other inflammatory diseases, such as Parkinson’s, Alzheimer’s and Crohn’s disease.

The Feinstein Institute, Academic Medical Center/University of Amsterdam and GSK-backed bioelectronics player SetPoint Medical announced the results, which were published in Proceedings of the National Academy of Sciences. It is the first study to examine the effect of stimulating the inflammatory reflex in humans. It involved 17 patients with active rheumatoid arthritis (RA), several of whom had previously failed multiple therapies, the partners said in a statement.

Patients had a stimulation device surgically implanted on the vagus nerve, which was then switched on and off according to a set schedule. Patient response was measured over 84 days and primary endpoints recorded at day 42 using a standard disease activity composite score that takes into account number of swollen and tender joints, patient and physician assessment of disease activity and serum C-reactive protein (CRP) levels.

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The results show that stimulating the vagus nerve blocks the production of TNF, one of several cytokines involved in rheumatoid arthritis, the statement said. No serious adverse events were reported.

“These results support our ongoing development of bioelectronic medicines designed to improve the lives of people suffering from chronic inflammatory diseases and give healthcare providers new and potentially safer treatment alternatives at a much lower total cost for the healthcare system,” said SetPoint Medical CEO Anthony Arnold in the statement.

Bioelectronics, also known as electroceuticals, are an emerging group of therapies that focus on stimulating the body’s electrical impulses to help it heal from illness. The theory is to bring about biochemical changes in the body that are typically caused by drugs, and to use the devices in combination with drugs or even replace them altogether.

“This is a real breakthrough in our ability to help people suffering from inflammatory diseases,” said Dr. Kevin J. Tracey, CEO of the Feinstein Institute for Medical Research, co-founder of SetPoint Medical and a study co-author, in the statement. “While we’ve previously studied animal models of inflammation, until now we had no proof that electrical stimulation of the vagus nerve can indeed inhibit cytokine production and reduce disease severity in humans."

Back in September, SetPoint picked up $15 million to advance its anti-inflammatory bioelectronic device, from Covidien Ventures and Boston Scientific ($BSX) as well as GlaxoSmithKline ($GSK). GSK has been stealthily working on electroceuticals since 2012 and recently said it plans to bring a device to market within the next decade. While it has funded a number of early-stage electroceuticals and has a $50 million venture fund, it also has its own prototypes in animal testing. It plans to start human trials using third-party devices next year, and begin testing its own electroceuticals in 2019.

- here's the statement

Special Report: FierceMedicalDevices' 2013 Fierce 15 - SetPoint Medical

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