SetPoint Medical based out of Valencia, CA presented at the ACR annual meeting this past weekend and highlighted positive first-in-human results from an open label pilot study focused on RA. The study results suggested that by stimulating the vagus nerve using a commercially available neuromodulation device, the inflammatory reflex can be regulated to improve “clinical manifestations of rheumatoid arthritis (RA)”. Although the study used a commercially available device, SetPoint is developing a proprietary neuromodulation device which is smaller and more compact, allowing it to be implanted directly on the vagus nerve. The device is also designed to be programmed using an iPad, eliminating the need for a custom programmer like other neuromodulators on the market. It is also projected to be more cost-effective over currently approved drugs to treat RA. Medgadget interviewed Anthony Arnold, CEO of SetPoint Medical (via phone) to discuss this new product, treatment, and the company’s focus for 2013.
Janelle Chang, Medgadget: Can you provide a brief explanation of the clinical procedure and how the device works?
Anthony Arnold, SetPoint Medical: The procedure is traditional where [a physician] performs surgery in the cervical neck area, right below your chin and implants the device on the vagus nerve. There are a few other companies that have been doing this for other indications now for more than 15 years. Tens of thousands of patients have had their vagus nerve stimulated for epilepsy, or heart failure. This is the first time the vagus nerve has been stimulated in humans for an inflammatory disease such as RA. SetPoint’s device is 95% smaller than the devices in use today. The entire device is implanted right on the vagus nerve…. About an inch long segment of a number 2 pencil [size-wise].
Janelle Chang: What is the current gold standard for this type of condition and how is this device a possible improvement?
Anthony Arnold: Current drugs on the market such as Enbrel and Remicade sell billions of dollars per year and the market is growing more than 10% each year because the drugs do work for many people…. But not all patients want to be on these types of potent drugs due to the concern over serious side effects. We help the physicians by giving them another tool or alternative to these potent drugs and help reduce the healthcare cost for these patients by up to 75%. The device, procedure, plus management of the device will cost approximately as much as 18 months of today’s drug therapy. Since the device will last about 10 years, patients will get 10 years of device therapy for the cost of only 12 to 18 months of drug therapy.
Janelle Chang: How does this differ from other vagus nerve stimulators on the market?
Anthony Arnold: Difference is with the frequency and duration of the pulses we deliver (compared to commercially available neuromodulation devices) – we administer few pulses at a lower power. Because we deliver fewer pulses over a shorter duration of time with a different pattern, our device can be much, much smaller. The device is so small it can be directly attached to the nerve itself and since it can be programmed with an iPad, making it user friendly.
Janelle Chang: Is there any risk to overstimulating the vagus nerve?
Anthony Arnold: Haven’t found any risk to overstimulating it. Biggest concern around overstimulation would be the nerve getting too used to it. Studies and experience with tens of thousands of patients implanted for other diseases have shown that’s not a significant concern. If you over stimulate with too much power, the patient can feel it and tell you it’s really uncomfortable and the degree of stimulation can be adjusted.
Janelle Chang: Why did the company choose to focus on RA versus other inflammatory diseases for the first generation product?
Anthony Arnold: We selected RA to start because it is a disease that responds rapidly to both drug and device therapy. When you start treating a patient and you don’t see a result within 2 weeks it’s unlikely it’s going to work. If you don’t see a result within a month it’s not going to work. The objective markers in the disease and the visible signs and symptoms are easy to measure and observe and there are standards already agreed upon. Compared to Crohn’s disease for example, some of the markers are good but the end points are much harder to discern and responses can require a longer time to observe.
Janelle Chang: What were the patient inclusion/exclusion criteria and study end points?
Anthony Arnold (supplemented by ACR poster presentation): The open label pilot study was patterned after a Phase 1 study for drugs e.g. Embrel so that the results could be reasonably compared. We recruited similar patient populations (male/female, 18-75 years of age) and sickness levels (at least 6 months onset RA as defined by 2010 ACR/EULAR criteria). Patients were “drug naïve” patients, largely disabled by the disease and with poor quality of life. The study end points included analysis of biomarkers (e.g. FACS, serum cytokines, LPS-induced TNF release assay), synovial biopsy, and various ACR and EULAR response rates. Six of the eight enrolled showed significant and meaningful improvement by EULAR and ACR standards.
Janelle Chang: Are larger clinical trials planned and will they focus exclusively on RA or other inflammatory diseases?
Anthony Arnold: In 2013, we will continue to develop the device but will put significant focus towards a randomized trail modeled much like a Phase 2 drug trial to prove in a blinded study the same results we saw in our pilot. We plan to include around 100-150 patients across multiple centers around the world. We also plan to do a similar pilot study specifically targeted at Crohn’s disease across Europe because for a Crohn’s patient there are very few therapies available unlike RA.
Company website: SetPoint Medical…
