SetPoint Medical has enrolled the first participant in the second stage of the RESET-RA pivotal study, which is assessing the company’s investigational platform technology to treat rheumatoid arthritis (RA).
This latest development follows receipt of the US Food and Drug Administration’s (FDA) approval to continue Stage 2 of the RESET-RA study. The approval was granted based on results from an interim data analysis.
The randomised, multicentre, sham-controlled, two-staged, double-blind pivotal study is evaluating the SetPoint system, which uses vagus nerve stimulation to activate the innate anti-inflammatory pathways.
The participant was enrolled by the Albuquerque Center for Rheumatology in New Mexico, US. The procedure was performed at the University of New Mexico Hospital in Albuquerque, New Mexico.
The FDA granted Breakthrough Device Designation to the SetPoint system to treat RA patients with incomplete response to, or intolerance to, multiple biologic drugs.
A small incision on the left side of the neck is used to implant a miniaturised stimulator on the vagus nerve.
After being surgically placed, the device is programmed to offer therapy automatically on a preset schedule.
SetPoint Medical president and CEO Murthy Simhambhatla said: “We are committed to delivering on our mission of pioneering a better alternative for the treatment of chronic autoimmune diseases – one with potentially less immunosuppresive risk, and lower cost than drug therapy – starting with RA, a serious autoimmune condition that causes significant pain and disability.
“The enrolment of the first patient in Stage 2 of our pivotal trial is a significant milestone on our journey toward gathering additional clinical evidence to support FDA approval of this novel approach.”
The RESET-RA study will assess the SetPoint System’s safety and efficacy to treat moderate-to-severe RA adult patients with an inadequate response or intolerance to biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).
Up to 250 patients will be enrolled in the study at 40 US sites.
The proportion of patients achieving an ACR20 response in the treatment group versus sham group at 12 weeks will be the study’s primary efficacy endpoint.