Interview with Dr. Hehenberger of Coronado Biosciences–Using worms to treat diabetes

Coronado Biosciences specializes in developing and applying immunotherapy biologic agents to treat autoimmune diseases. This company is now working on a novel way to use the eggs of parasites to slow down the progression of Type 1 Diabetes.

We spoke with Dr. Karin Hehenberger, the executive Vice President and Chief Medical Officer at Coronado BioSciences, about this revolutionary treatment.

Coronado Biosciences is currently focusing on a project involving the use of pig whipworm eggs to manage and prevent Type 1 Diabetes. How exactly do these eggs work within the human body to help with Type 1 Diabetes?

The TSO (Trichuris suis) ova, or the eggs from the pig whipworm, are given to a patient in a liquid solution. They are tasteless, odorless, and microscopic, so you can't see them. Every two weeks the patient takes 15 milliliters of the ova solution. The solution then goes down the intestinal tract into the stomach and the intestines, where the eggs hatch and grow into little larvae, which are also microscopic.

During the time when they're alive, they have an affect on the immune system. In a person with an autoimmune disease, the immune system cannot decipher between one's self and one's non-self. When these larvi hatch, the body starts trying to get rid of them instead of hurting one's own body. This shifts how the immune system works, so the body is essentially healing itself. The larvae then die by the end of the two weeks.

In Type 1 Diabetes specifically, when the patient has high blood sugar, the beta cells in the pancreas are gone because the immune system has destroyed them. In a person without diabetes, the body is trying to defend itself from foreign objects, but in Type 1 Diabetes, the body is hurting his or her own pancreas.

We are trying to do two things with our studies on Type 1 Diabetes–first, we want to identify patients before they have high blood sugar and before the beta cells have been destroyed. The second approach we are taking is to treat people who have already developed diabetes. In the beginning of developing diabetes, there is a so-called "honeymoon period," when there are still beta cells that can produce insulin. We want to maintain beta cell function for a period of time in people with diabetes so they have less risk of developing diabetes-related complications. This would be our reversal trial.

How did you and your team discover that this TSO compound could be a possible agent to help with Type 1 Diabetes?
There are many animal studies in this field which have been conducted. One in particular involved the NOD (non-obese diabetic) mice. The NOD mice model shows that if you give these mice the parasite, you can prevent diabetes from ever occurring. That was a strong piece of evidence that we used to help develop our method. We know a lot about diabetes and since it is an autoimmune disease, there is a lot of speculation if you can shift the immune system from hurting your own body, you can prevent people from having Type 1 Diabetes.

So now you are starting clinical trials for this process with Type 1 Diabetes. How far along are these trials and what do these trials entail for the participants?
The trials are being planned right now, but it will be in collaboration with investigators and under the guidance of the FDA. In the case of the reversal trial, they would take the regular insulin and medication and add TSO.

In the case of prevention, we would like to focus on children who are predisposed to diabetes. The optimal situation would be to take TSO every two weeks for about a three-year period before the end of the trial. Hopefully, that amount of time would help to prevent them from developing diabetes altogether.

Would the TSO eventually completely cure Type 1 Diabetes in the patients over time, or would it be an ongoing treatment for life?
In the reversal diabetes trial, it cannot reverse the disease completely. We can hope that the symptoms of diabetes would be milder, but when you have only 10-20% beta cell function left, it is not possible to cure. The reversal treatment would be more about the maintenance of the existing beta cell function, so that instead of going from 10-20% beta cell function to 0% and having risk of complications, we hope to keep the diabetics at a certain beta cell function, which can be monitored.

Looking toward the future, are there any other new treatments that Coronado BioSciences is researching for diabetes, Type 1 or Type 2?
We have not yet talked about Type 2 Diabetes in relation to the TSO compound, but in Type 2 Diabetes, there is a lot of evidence that there is an autoimmune component to it, which worsens the disease. I can see eventually, if the Type 1 Diabetes treatment is approved, that people with Type 1 Diabetes would like to try TSO as well because their glucose levels may improve. If you can avoid the highs and lows that come with glucose level imbalance, it has an enormous impact on everyday life. I can see us going in that direction if everything goes well.

You yourself were diagnosed with Type 1 Diabetes. How has that affected your career choices and your outlook on diabetes research and development?
I was diagnosed with Type 1 Diabetes when I was 16. I was hospitalized and put on insulin immediately. It really was a big life-changing moment, especially as a teenager. I had diabetes for almost 20 years before I developed serious micro-vascular complications, and I need treatments for my eyes and kidney. Eventually, my kidney could not take it anymore, and I was lucky to have my father give me one of his kidneys. After getting the kidney, I was also offered a pancreas transplant. Every day I wake up and am grateful for the family who gave me the pancreas, and also for all the people that made it possible. These experiences gave me a very good sense of what it's like to live with diabetes and how glucose ups and downs affect a person's life.

I studied medicine and did my PhD in molecular biology with a focus on diabetes. I think of the patient in a more holistic way, and diabetes is a good example for that, because it affects the entire body and people's behavior. I was definitely driven by diabetes my entire career and am in a place right now that I hope I can have value and learn more about diabetes.

To learn more about this study, visit Coronado Bioscience's website by clicking here.

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