February 1, 2021
RESET-RA Study: First patient was enrolled reports SetPoint Medical. The study received an Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to evaluate SetPoint Medical’s proprietary bioelectronic platform in patients with rheumatoid arthritis (RA).
The primary purpose of this multicenter, randomized, sham-controlled, double-blind pivotal study is to evaluate the safety and efficacy of the SetPoint bioelectronic 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 RESET-RA Study will enroll up to 250 patients at 40 sites in the U.S. The primary efficacy endpoint is the proportion of patients achieving an ACR20 response in the treatment versus sham groups at 12 weeks.
“Vagus nerve stimulation represents a completely novel approach for the treatment of autoimmune diseases,” said Jeffrey R Curtis, MD MPH, Professor of Medicine in the Division of Clinical Immunology and Rheumatology at the University of Alabama at Birmingham, and National Co-Principal Investigator. “Stimulating neural pathways that control systemic inflammatory pathways offers a potentially completely different way of treating RA patients who have experienced inadequate responses or intolerance to biologic agents or targeted synthetic DMARDS.”
The first patient enrolled in the RESET-RA Study was by Pendleton Wickersham, MD, at Clinical Trials of Texas in San Antonio, Texas, and Daniel Peterson, MD, at Arise Austin Medical Center in Austin, Texas. The SetPoint System contains a miniaturized stimulator, approximately one inch long, that is surgically implanted on the left side of the neck onto the vagus nerve. All eligible subjects will undergo the implantation surgery under general anesthesia in an outpatient setting. Once surgically placed on the vagus nerve, the device is programmed to automatically deliver electrical doses on a preset schedule.
“Neuromodulation of systemic inflammatory pathways using vagus nerve stimulation is an exciting new approach to the treatment of automimmune diseases such as RA,” said Mark Richardson, MD PhD, Director of Functional Neurosurgery at Massachusetts General Hospital, and National Co-Principal Investigator. “We are at the dawn of a new therapeutic era where an understanding of how the brain controls inflammation might lead to new and effective ways of treating chronic inflammatory disorders.”
“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,” said David Chernoff, MD, Chief Medical Officer of SetPoint Medical. “We look forward to initiating the pivotal study with our novel platform.”