Michael Barbella, Managing Editor02.16.21
SetPoint Medical has officially begun its clinical trial that will examine its rheumatoid arthritis treatment platform.
The compan recently announced the first patient enrollment in the RESET-RA study, which received an Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). The study will evaluate the firm's proprietary bioelectronic platform in patients with rheumatoid arthritis (RA). The first patient was enrolled by Pendleton Wickersham, M.D., at Clinical Trials of Texas in San Antonio, Texas, and Daniel Peterson, M.D., at Arise Austin Medical Center in Austin, Texas.
“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, M.D. Ph.D., 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.”
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 study will enroll up to 250 patients at 40 sites in the United States. The primary efficacy endpoint is the proportion of patients achieving an ACR20 response in the treatment versus sham groups at 12 weeks.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.
“Vagus nerve stimulation represents a completely novel approach for the treatment of autoimmune diseases,” said Jeffrey R Curtis, M.D. 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.”
“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, M.D., chief medical officer of SetPoint Medical. “We look forward to initiating the pivotal study with our novel platform.”
The compan recently announced the first patient enrollment in the RESET-RA study, which received an Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA). The study will evaluate the firm's proprietary bioelectronic platform in patients with rheumatoid arthritis (RA). The first patient was enrolled by Pendleton Wickersham, M.D., at Clinical Trials of Texas in San Antonio, Texas, and Daniel Peterson, M.D., at Arise Austin Medical Center in Austin, Texas.
“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, M.D. Ph.D., 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.”
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 study will enroll up to 250 patients at 40 sites in the United States. The primary efficacy endpoint is the proportion of patients achieving an ACR20 response in the treatment versus sham groups at 12 weeks.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.
“Vagus nerve stimulation represents a completely novel approach for the treatment of autoimmune diseases,” said Jeffrey R Curtis, M.D. 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.”
“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, M.D., chief medical officer of SetPoint Medical. “We look forward to initiating the pivotal study with our novel platform.”
