FDA approves exemption for implantable bioelectric therapy for RA
The FDA has approved an investigational device exemption for SetPoint Medical to conduct a pilot trial in the United States on the use of an implantable bioelectric therapy among adult patients with drug-refractory rheumatoid arthritis.
Patients will have the device surgically implanted on their vagus nerves, and it will be activated based on a predetermined dosage schedule, according to a company press release. The researchers will enroll 15 patients with RA, aged 22 to 75 years, who have failed multiple biologic agents, to test the device’s safety and efficacy across seven investigational centers.
“The trial we are about to initiate builds off the earlier published trial design in several important ways,” David Chernoff, MD, chief medical officer of SetPoint Medical, told Healio Rheumatology. “We are offering this novel bioelectronic therapy to RA patients who have failed or been intolerant to multiple biologic agents with different mechanisms of action for whom there are few remaining options to treat their drug refractory disease.”
According to Chernoff, the researchers will evaluate the enrolled patients for therapeutic response in three ways.
“Standard disease activity metrics like the DAS28CRP will be measured over time to see if the clinical exam improves over the course of the 12-week trial,” he said. “We will also assess disease activity using Gadolinium enhanced wrist MRI in order to obtain quantitative images of joint inflammation using the standardized RAMRIS scoring system.”
Chernoff added that the researchers will follow an extensive set of biomarkers of disease activity, including the serum MBDA scores and ex vivo stimulated cells assays, as well as high resolution mass spec lipidomic profiling in order to assess molecular responses to vagal nerve stimulation.
“The trial will be conducted in multiple U.S. rheumatology clinical centers in close proximity to neurosurgical centers of excellence where the device implantation will be performed,” he said.
According to SetPoint, the company is developing a novel, proprietary bioelectronic treatment platform that activates the body’s inflammatory reflex to activate systemic anti-inflammatory pathways. The company noted that it aims to address unmet patient needs by delivering targeted digital doses to modulate physiological circuits for treatment of diseases that have historically been treated with drugs.
“Gaining [investigational device exemption] approval for the clinical trial with our propriety device is an important milestone in moving our bioelectronic medicine program towards commercialization,” Anthony Arnold, CEO of SetPoint Medical, said in a company press release. “This strengthens our resolve to give physicians a new therapeutic alternative designed to be safer and more cost effective for patients with not only RA but other chronic inflammatory diseases.” – by Jason Laday
Disclosure: Chernoff and Arnold report employment with SetPoint medical.