The Lancet Rheumatology Publishes Clinical Trial Data Demonstrating Promising Safety and Efficacy Profile for a Novel Bioelectronic Device in Patients with Drug Refractory Rheumatoid Arthritis
VALENCIA, Calif., July 29, 2020 (GLOBE NEWSWIRE) -- SetPoint Medical, Inc. today announced that data from a first-in-human pilot trial that evaluated its proprietary Vagus Nerve Stimulation (VNS) microregulator in a cohort of patients with multi-drug refractory rheumatoid arthritis (RA) were published in The Lancet Rheumatology. The study found the bioelectronic device reduced signs and symptoms of disease in 50% of the treated patients after 12 weeks of stimulation. This study marks the first to demonstrate the functionality and safety profile of SetPoint’s microregulator in patients with drug refractory RA.
“The development of new therapies to address unmet needs in patients with RA is extremely important,” said Dr. Jeffrey R. Curtis, Professor of Medicine in the Division of Clinical Immunology and Rheumatology at the University of Alabama at Birmingham (UAB), and national Co-Principal Investigator for SetPoint Medical’s upcoming pivotal trial of VNS in patents with RA. “This pilot study expanded the available evidence on the safety and efficacy from a previously conducted open-label European proof-of-concept study of VNS in patients with RA.”
“These new data confirm that activation of the cholinergic anti-inflammatory pathway by vagus nerve stimulation can reduce disease activity even in patients who have failed to respond to multiple classes of biological drugs and JAK inhibitors,” said Dr. David Chernoff, Chief Medical Officer of SetPoint Medical.
Based on the results of this pilot study and proof of concept data for the European study, the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) for SetPoint Medical to study its proprietary VNS system in a larger double blind, randomized, sham-controlled pivotal trial to be conducted at multiple study sites in the United States.
The two-stage, pilot study evaluated the safety and efficacy of the SetPoint Medical system i 14 patients with multi-drug-refractory RA over 12 weeks. Patients in this study had inadequate response to multiple prior biological drugs or JAK inhibitors, with 9 of 14 patients having had an inadequate response to both biological drugs and JAK inhibitors. The patients were enrolled in two phases: Stage 1 (3 patients) was open-label, and Stage 2 (11 patients) was randomized and sham controlled, with the sites and patients blinded to treatment assignment. The primary outcome was treatment-emergent incidence rates of adverse events. A secondary outcome was the assessment of clinical efficacy.
In this pilot study, 50% of stimulated patients had a reduction in Disease Activity Score (DAS28-CRP) that exceeded the minimal clinically important difference for this measure, and 2 patients went into remission, as defined by a DAS28-CRP of less than 2.6 at 12 weeks. The release of pro-inflammatory cytokines decreased by more than 30% in stimulated groups after 12 weeks. None of the patients in the sham stimulated group had a clinical response or a mean decrease in pro-inflammatory cytokines. There were no device-related or treatment-related serious adverse events. Surgery-related adverse events included a single case each of transient Horner’s syndrome and left vocal cord paralysis that resolved without clinically significant sequelae.
Full results published in The Lancet Rheumatology available online: https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(20)30172-7/fulltext
About SetPoint Medical
SetPoint Medical is a privately held clinical-stage bioelectronic medicine company dedicated to treating patients with chronic autoimmune diseases. SetPoint Medical’s bioelectronic medicine platform is intended to offer patients and providers a treatment alternative for rheumatoid arthritis, inflammatory bowel disease and other chronic autoimmune conditions with potentially less risk and cost than drug therapy. The company is developing a novel bioelectronic medicine platform that stimulates the vagus nerve to activate the inflammatory reflex to produce a systemic immune-restorative effect. Current investors in the company include New Enterprise Associates (NEA), Morgenthaler Ventures, Topspin Partners, SightLine Partners, GlaxoSmithKline’s Action Potential Venture Capital and Boston Scientific as well as an additional undisclosed strategic investor (leading medical device company). For more information, visit www.setpointmedical.com.
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