Tour of Celiac Treatments…E40

Over the counter gluten degrading enzymes don’t work. I repeatedly say that if they worked, the company should put their gluten degrading enzymes through the FDA drug approval process to prove it. The company could make a lot more money if the product were being sold as an FDA approved drug rather than a supplement. Well, Nemysis is doing just that.

Nemysis found a bacteria that creates a gluten degrading enzyme in the soil of Northern Italy and they are calling it E40. In a Petri dish, the E40 enzyme is able to break down gluten without the acidic environment of the stomach and small intestine. The E40 enzyme seems to work better in a simulated digestive system environment. But the difference between working in a Petri dish vs. working in the human body is vast. At this point, there is no record of a clinical trial in live subjects.

Nemysis is taking a two-pronged approach to this drug. It seems the company is going to release a version of E40, called E40-01, as a non-drug for the gluten sensitive and another version, E40-02 will go through the FDA drug approval process for celiac disease. Nemysis is already attempting this process with their iron deficiency anemia drug. I’m not sure what the differences between the over the counter or FDA approved drug will be. We will have to wait on that answer.

This is a new drug for me. I find their business approach to E40 very interesting. We will have to see how this plays out.

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