SetPoint Medical Gains FDA Nod to Continue RESET-RA Study

SetPoint Medical has gained U.S. Food and Drug Administration (FDA) approval to continue its RESET-RA clinical study.
 
The study gained Investigational Device Exemption (IDE) approval from the FDA to evaluate SetPoint’s therapeutic platform for rheumatoid arthritis (RA). It began in January 2021.
 
The RESET-RA study will evaluate safety and efficacy of SetPoint’s platform for moderate-to-severe RA in patients who are incomplete responders or intolerant to biologic or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs).
 
The study will enroll up to 250 patients at 40 U.S. sites in two stages with an interim analysis after Stage 1’s completion. Enrollment of 60 patients in Stage 1 finished in March 2022 at 18 U.S. sites.
 
The FDA approved study continuation without changes to the study protocol after review of Stage 1 safety and efficacy outcomes.
 
“This is another significant milestone for SetPoint Medical as we continue to develop this novel treatment option for RA patients,” David Chernoff, MD, chief medical officer of SetPoint told the press. “There is a significant unmet medical need for new treatment alternatives for RA patients whose disease activity is inadequately controlled with conventional biologic or synthetic DMARDs. We look forward to enrolling the remaining 190 patients in the second stage of the study.”
 
According to the company, RESET-RA is the first study of its kind to assess vagus nerve stimulation to treat RA. The vagus nerve plays a critical role in maintaining inflammatory balance. The RESET-RA study is actively recruiting following approval for Stage 2.