FDA approved the initiation of Stage 2 of SetPoint Medical’s pivotal IDE study based on the trial meeting the pre-specified criteria for interim analysis
Valencia, CA – September 13, 2022 – SetPoint Medical, a clinical-stage healthcare company dedicated to patients with chronic autoimmune disease, announced U.S. Food and Drug Administration (FDA) approval for continuation of the company’s RESET-RA study. The study, which received an Investigational Device Exemption (IDE) from the FDA to evaluate SetPoint Medical’s proprietary therapeutic platform in patients with rheumatoid arthritis (RA), was initiated in January 2021.
The primary purpose of the RESET-RA study, a two-staged, multicenter, randomized, sham-controlled, double-blind pivotal study, is to evaluate the safety and efficacy of SetPoint’s therapeutic platform in patients with moderate-to-severe RA who are incomplete responders or are intolerant to biologic or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs). The primary efficacy endpoint is the proportion of patients achieving an ACR20 response in the treatment group compared to sham group at 12 weeks.
The RESET-RA study is designed to enroll up to 250 patients at 40 sites across the US in two stages with a planned interim analysis after completion of Stage 1. The enrollment of 60 patients in Stage 1 was completed in March 2022 at 18 sites in the US. The FDA approved study continuation with no changes to the study protocol following their review of both safety and efficacy outcomes from Stage 1.
“This is another significant milestone for SetPoint Medical as we continue to develop this novel treatment option for RA patients,” said David Chernoff, MD, Chief Medical Officer of SetPoint Medical. “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.”
RESET-RA Study is the first of its kind study to evaluate vagus nerve stimulation for treatment of RA. The vagus nerve plays an essential role in maintaining inflammatory balance, and therefore, is a target for treating chronic conditions associated with an imbalanced immune response. With approval for Stage 2, the RESET-RA study is now actively recruiting.
About SetPoint Medical
SetPoint Medical is a privately held clinical-stage healthcare company dedicated to treating patients with chronic autoimmune diseases. The company is developing a novel platform designed to stimulate the vagus nerve to activate the inflammatory reflex to produce a systemic immune-restorative effect. SetPoint Medical’s platform technology is intended to offer patients and providers a treatment alternative for rheumatoid arthritis, inflammatory bowel disease and other chronic autoimmune conditions with potentially less risk and cost than drug therapy. For more information, visit www.setpointmedical.com.