SetPoint Medical said today it launched the pilot trial of its neurostimulation device, looking to explore the system’s ability to to treat patients with drug refractory rheumatoid arthritis.
The device is designed to be surgically placed on the vagus nerve to activate the body’s natural inflammatory reflex, the Valencia, Calif.-based company said.
“Despite the effectiveness of biologic and targeted agents for the treatment of rheumatoid arthritis, many patients either do not respond, lose therapeutic response or are intolerant to these agents. There remains a real need to develop alternative therapeutic approaches for the treatment of patients with drug refractory disease. Bioelectronic medicine represents a novel and promising approach for patients who need other options for treatment of their rheumatoid arthritis,” trial principal investigator Dr. Mark Genovese of the Stanford University Medical Center said in a prepared release.
“The new implantable device designed by SetPoint Medical is an exciting development in RA therapy. It is extremely easy to place, with no external battery or wires that need to be connected, and it can even be removed if needed. All of these things make it an ideal potential new option for drug refractory rheumatoid arthritis,” Dr. Heather Spader of Joe DiMaggio Children’s Hospital said in prepared remarks.
The multi-center study will explore the safety and efficacy of the device in adult patients with rheumatoid arthritis who have failed with multiple biological agents. The study is slated to enroll a total of 15 subjects between 22 and 75 at seven US centers, SetPoint Medical said.
“I have conducted more than 100 clinical trials, and it is incredibly exciting to be the first center in the U.S. to enroll a subject in this trial of SetPoint Medical’s bioelectronic modulation system for the treatment of patients with rheumatoid arthritis who have had inadequate responses to multiple treatments. The opportunity to try a completely different therapeutic approach for my RA patients will hopefully lead to another treatment option for this very debilitating disease,” AARDS Research CEO Dr. Norman Gaylis said in a press release.
“We are recruiting patients to evaluate SetPoint’s proprietary miniaturized, rechargeable wireless bioelectronic device for RA, building on our body of previous work defining the mechanism of action and proof of concept. This is important because despite the availability of oral disease-modifying drugs such as methotrexate and multiple targeted biologic agents, only one third of RA patients on current therapies meet criteria for clinical remission,” SetPoint chief medical officer Dr. David Chernoff said in a prepared statement.
SetPoint Medical won FDA investigational device exemption clearance to launch the trial last December.