Clinical Results in RA and Crohn’s, Looking Ahead at MS
By Anthony Arnold, CEO of SetPoint Medical
Inflammation – it’s a term that conjures up two very different scenarios in the body: one that is vital to healing and another that can lead to chronic inflammatory diseases. Inflammation, at its best, is the part of the body’s fight response where it rushes blood, fluid and proteins to an impacted area to create swelling and heat to protect, repair and heal.
In the second scenario, when this carefully regulated system goes awry and inflammation in the body becomes chronic and systemic, it can lead to a growing list of cardiovascular and autoimmune diseases including heart disease, stroke, peripheral vascular disease, rheumatoid arthritis (RA), Crohn’s disease and multiple sclerosis (MS).
Within the last decade, chronic disease numbers have grown rapidly. About half of all adults, an estimated 117 million people, are currently living with one or more chronic health conditions, and one in four adults have two or more chronic health conditions, according to the CDC.
While medical devices have not historically played a role in treating inflammatory diseases, that is changing due to the fast-growing field of bioelectronic medicine.
Bioelectronic medicine builds on traditional neuromodulation and combines advances in bioengineering, immunology and neuroscience with a deeper understanding of disease mechanisms to create a new way to harness the body to fight chronic conditions using electric pulses. What sets bioelectronic medicine apart is the biological impact it has in the body, going beyond the mediation of symptoms to address the underlying disorder by harnessing the body’s own mechanisms to treat disease.
Scientists and researchers at the NIH, DARPA, MIT, Northwell Health’s Feinstein Institute, GSK, SetPoint Medical and other academic institutions believe bioelectronic medicines will have an important role to play in diseases ranging from RA and Crohn’s to Alzheimer’s, asthma, MS and diabetes, leading to more than $1 billion being invested in bioelectronic medicine to date.
California-based SetPoint Medical is first in the clinic with bioelectronic medicine trials in rheumatoid arthritis and Crohn’s disease. SetPoint is targeting chronic inflammatory diseases, stimulating the immune cells in the spleen, gut and elsewhere to drive a coordinated response to regulate inflammation.
SetPoint bioelectronic implant
First Clinical Data: RA and Crohn’s
SetPoint published data demonstrating positive results from a first-in-human trial in rheumatoid arthritis in Proceedings of the National Academy of Sciences (PNAS) (available here).
Eleven of 17 patients saw a clinically meaningful drop in their DAS28 (Disease Activity Score).
Seven of the ten patients that had failed to respond to multiple biologic agents of differing mechanisms demonstrated robust DAS28 responses.
The findings indicate that active electrical stimulation of the vagus nerve inhibits tumor necrosis factor (TNF) production in RA patients and significantly attenuates RA disease severity.
SetPoint is following up its proof-of-concept trial with a U.S. pilot trial in RA using its proprietary bioelectronic medicine device.
SetPoint recently completed a bioelectronic medicine study in Crohn’s disease, conducted at five European centers in 18 patients with severe Crohn’s who were not responsive to traditional TNF-targeting drug therapy.
We presented positive initial results in Crohn’s disease at the 2016 United European Gastroenterology meeting: six of the eight patients had seen a substantial reduction in their disease activity index scores, and three were in remission from the disease.
As SetPoint looks ahead, several chronic disease areas are emerging as key bioelectronic medicine therapy targets, and our company is exploring a number of these. One of our preclinical programs explores bioelectronic medicine’s potential role as a treatment for MS.
New Target: Multiple Sclerosis
In late 2017, SetPoint presented positive data from a study exploring the therapeutic effects of a bioelectronic medicine approach for MS at the European Committee and Americas Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS-ACTRIMS).
Data showed that SetPoint’s therapy reduced demyelination and, more importantly, accelerated remyelination, which is a significant challenge in treating MS with currently available drugs/biologics.
The study also demonstrated this approach reduced leakage of the blood-spinal cord barrier, which can prevent immune cell infiltration and further reduce disease progression.
Current approved treatments for MS target the overactive immune response but do not repair damage to the myelin sheath – a critical aspect.
These results show promise for a possible bioelectronic treatment for MS and lay the groundwork for further studies.
Bioelectronic Medicine Device: How it Works
Bioelectronic medicine uses a small implanted device to deliver targeted electrical pulses along existing physiologic pathways, triggering the body’s natural biological responses to create a systemic disease-fighting effect that can last hours or days.
SetPoint developed the first self-contained rechargeable bioelectronic device for placement on the vagus nerve to deliver electrical doses on a preset schedule. This approach requires only one surgical site, potentially making implantation take less time with less risk for patients. Bioelectronic doses are prescribed by the treating clinician using a prescription pad application on a standard iPad and the doses are automatically delivered by the implant.
Bioelectronic medicine has the potential to offer an alternative for physicians and patients with improved quality of life – a solution that could provide fewer side effects, lower cost and better compliance. SetPoint continues its research to bring this important new medical technology to patients.
The need for new treatment options for inflammatory diseases is great and urgent. Many believe this new approach could be life changing for patients living with chronic conditions and a disruption to what we previously believed was possible in treating them.
Anthony Arnold is CEO of SetPoint Medical, a biomedical technology company developing a bioelectronic therapy for inflammatory diseases. Arnold has more than 20 years of medical device industry experience, including key roles at Advanced Bionics/Boston Scientific, Medtronic and Smith+Nephew. For more info: www.setpointmedical.com.