SetPoint Medical has enrolled the first patient in the RESET-RA study of its bioelectronic platform in patients with rheumatoid arthritis (RA).
The development comes after the US Food and Drug Administration (FDA) granted an Investigational Device Exemption (IDE) approval to analyse the company’s proprietary platform.
The multi-centre, randomised, sham-controlled, double-blind pivotal study will assess the safety and efficacy of SetPoint bioelectronic platform in moderate-to-severe RA patients, who are incomplete responders or intolerant to biologic or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs).
It will have up to 250 patients at 40 US sites. The proportion of patients achieving an ACR20 response in the treatment versus sham groups at 12 weeks will form the study’s primary efficacy endpoint.
SetPoint Medical chief medical officer David Chernoff said: “There is a significant unmet medical need for finding new ways of treating RA patients whose disease activity is inadequately controlled with conventional biologic or targeted synthetic DMARDS.
“We look forward to initiating the pivotal study with our novel platform.”
The first patients were enrolled at Clinical Trials of Texas in San Antonio, Texas, US, and Arise Austin Medical Center in Austin, Texas.
The SetPoint System has a miniaturised stimulator, about 1in long, which is surgically implanted on the left side of the neck onto the vagus nerve.
All eligible participants will undergo implantation surgery under general anaesthesia in an outpatient setting.
On surgically placing the device on the vagus nerve, it is programmed to automatically offer electrical doses on a preset schedule.
Last October, SetPoint Medical secured breakthrough designation from the US Food and Drug Administration (FDA) for its new bioelectronic device.