First Patient Enrolled in SetPoint Medical’s Stage 2 Pivotal Study for Treatment of RA

The first participant has been enrolled in Stage 2 of SetPoint Medical’s RESET-RA pivotal study, which is evaluating SetPoint Medical’s investigational platform technology for treatment of rheumatoid arthritis (RA) using vagus nerve stimulation to activate innate anti-inflammatory pathways. The company recently announced FDA approval for continuation to Stage 2 of the study based on outcomes from an interim data analysis.
 
“We are committed to delivering on our mission of pioneering a better alternative for the treatment of chronic autoimmune diseases – one with potentially less immunosuppressive risk, and lower cost than drug therapy – starting with RA, a serious autoimmune condition that causes significant pain and disability,” said Murthy V. Simhambhatla, Ph.D., president and CEO of SetPoint Medical. “The enrollment 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 study participant was enrolled by Leroy Pacheco, M.D., of the Albuquerque Center for Rheumatology. The procedure was performed by Heather Spader, M.D., and James Botros, M.D., at University of New Mexico Hospital in Albuquerque.
 
“Stimulating the vagus nerve to control systemic inflammation offers a promising new way of treating patients with RA and other inflammation-mediated diseases,” said Dr. Pacheco, the site’s rheumatologist principal investigator. “Many RA patients experience inadequate response or intolerance to biologic therapies and are looking for alternative treatment options. The RESET-RA study represents an opportunity to evaluate this investigational approach for these patients.”
 
The SetPoint system has been granted FDA Breakthrough Device Designation for patients with RA who have incomplete response to, or are intolerant to, multiple biologic drugs. The system consists of a miniaturized stimulation device that is placed on the vagus nerve through a small incision on the left side of the neck during an outpatient procedure. Once surgically placed, the device is programmed to automatically deliver therapy on a preset schedule.

About the Trial

“RESET-RA is an innovative trial for the field of rheumatology and we are excited about our continued participation,” said Valarie Jackson, clinical research site director for Albuquerque Center for Rheumatology. “We enrolled multiple patients in Stage 1 of the study, and are looking forward to contributing more participants in the second stage of the study.”
 
The RESET-RA study is the first-of-its-kind study to evaluate vagus nerve stimulation for the treatment of RA. The two-staged, multicenter, randomized, sham-controlled, double-blind pivotal study will enroll up to 250 patients at 40 sites across the United States.
 
The study is designed 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 (a composite measure of the effectiveness of arthritis treatments set forth by the American College of Rheumatology) in the treatment group compared to sham group at 12 weeks.