SetPoint Medical has completed enrollment in the US Food and Drug Administration (FDA) pilot investigational device exemption (IDE) study assessing its bioelectronic device to treat patients with drug refractory rheumatoid arthritis (RA).
The bioelectronic device from SetPoint Medical is about one inch long. Once surgically placed on the vagus nerve, the device is programmed to automatically deliver electrical doses on a preset schedule.
The primary purpose of the multi-center, randomized study is to evaluate the safety and tolerability of SetPoint’s device, which will be surgically placed on the vagus nerve.
The study will include 14 subjects who had failed or were intolerant of multiple mechanistically different, biologic therapies.
Initial feedback from neurosurgeons performing the implantation has been positive. The company expects the data readout to come in the first quarter of next year.
University of Pittsburgh Medical Center Neurological Surgery Associate Professor and a surgical investigator in the study R. Mark Richardson said: “While vagus nerve stimulation has demonstrated success in treating neurological conditions such as epilepsy for more than 20 years, this unique therapeutic approach is a compelling and exciting development for the treatment of chronic autoimmune diseases including rheumatoid arthritis.
“Implanting this miniaturized, integrated device directly on the vagus nerve was relatively straightforward, requiring only one small incision, and I look forward to the safety and tolerability results.”
SetPoint Medical chief medical officer David Chernoff said: “Physicians and their patients who have failed conventional therapy desperately need alternative approaches for the treatment of drug refractory RA.
“We were highly gratified with the rapid enrollment in our study and look forward to presenting the results of the trial early next year.”
SetPoint Medical is engaged in the development of bioelectronic medicine for treating patients with chronic autoimmune diseases.
The company is in the development of a bioelectronic medicine platform, which intends to offer patients with alternative treatment for rheumatoid arthritis, Crohn’s disease and other chronic autoimmune conditions with potentially less risk and cost than drug therapy.