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The Future of Autoimmune Treatment

This session featured Dr. Barbara Fox, CEO of Rheos Medicines, Dr. David Chernoff, CMO of Setpoint Medical, and Lilly Stairs, Vice Chair of the Board of Directors of the Autoimmune Association, who came together to close out the Summit in a discussion about the future of biotech treatments for autoimmune conditions.

Recorded October 2021 at the Autoimmune Community Summit.

Dr. Fox on Precision Medicine

Dr. Fox represents Rheos Medicines, a biopharmaceutical company developing novel medicines to treat autoimmune and inflammatory diseases with greater precision by targeting the metabolic ‘hubs’ of the immune system.

“The easiest way to start,” Dr. Fox explained, “is to kind of take a step back and think about what the immune system does. When a normal functioning immune system responds to an infection, bacteria or virus that comes in, it needs to turn on incredibly fast. It uses an enormous amount of energy to fight off this threat. Once the threat has been neutralized, the immune system has to very actively turn itself off or else the body becomes completely overwhelmed with that inflammatory response. It’s one of the most energy-demanding systems in the body.”

Metabolism is the process of how the body uses energy, and that is what Rheos studies, with the goal of finding drugs that can affect that process, and what makes patients’ immune responses different.

Precision Medicine takes into account individual variability in genes, environment, and lifestyle for each person to predict which treatments and preventions work best in what groups of people. This has been more available in cancer, but less so in autoimmune diseases, so far.

Without precision medicine, treatments can be very hit and miss. This encourages insurer policies like step therapy or “treat to fail”. Being able to precisely predict how someone will respond to a therapy, eliminates much of the trial-and-error phase.

On the importance of developing precision medicine, Dr Fox added, “As you know, it’s not just that you had to suffer for an extra six months without being treated, but that the untreated disease can cause permanent damage.”

“My hope for the future is that we can have more options available for patients, better insights into what’s going to work where, so that we can deal with these extraordinarily complex diseases in a meaningful way.”

Dr. Chernoff on Bioelectronic Medicine

Dr. Chernoff represents Setpoint Medical. His passion and interest in autoimmune disease was cemented during the early years of the AIDS epidemic, when there was so little guidance and so few tools in immune disease.

The brain plays an important role in inflammation. It “listens” to the immune system and organs by using the vagus nerve, the longest of the cranial nerves. Taking a Bioelectronic Medicine approach has value because of how few drugs work in all patients. Bioelectronic medicine allows scientists to implant devices that can be activated when needed to stimulate or dial down a nerve’s activity. This is particularly useful in nerves that regulate the body’s many immune and metabolic responses.

“For the last 25 years people in the epilepsy field have been implanting devices that are used to control epilepsy. So, the idea of using something to stimulate the vagus, and the surgery involved, is well established.” The technology used in epilepsy is relatively large, so Setpoint set out to develop something smaller and less invasive.

In brief, a patient can have an electronic device about the size of a penny implanted next to the vagus nerve. This is an outpatient procedure. The device is controlled by an “electronic prescription pad” to control the precise delivery of impulses to the vagus nerve. This device is in clinical trials in the US currently.

Dr. Chernoff explained how in clinical trials, the earlier, larger versions of these devices were tested on autoimmune patients who had experienced no improvement on other treatments. The results were promising and showed reduction in disease activity.

“We conducted a pilot study of the miniaturized device and found that patients with RA who had failed almost everything (biologics, methotrexate, jak inhibitors), that in half of those patients we were able to get significant declines in disease activity, similar to what drugs might do.” And in discussing why these trials are so complex he added, “There is a balance between suppressing your immune system so that your psoriasis and your Crohn’s goes away, and not killing the person with infections. That is the constant battle, to figure out where is the right setpoint (and that’s why our company is called SetPoint) where you find the balance between those opposing forces.”

 

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