If you are a drug developer dealing with the lack of cures for Celiac Disease — this project developed E40, a single-enzyme treatment that destroys gluten's toxic potential. It can be classified as a medical device, which shortens the time to market.
Preventive Enzyme Treatment for Celiac Disease and Gluten Sensitivity
Imagine a biological shield you take before eating that breaks down gluten before it can cause harm. This enzyme acts like a pair of molecular scissors that works in both the stomach and intestines to neutralize gluten. It prevents the inflammatory reaction that makes people with gluten intolerance feel sick.
What needed solving
Celiac Disease and NCGS affect up to 10% of the population, but the only current management is a strict, expensive, and difficult Gluten Free Diet. There is a massive unmet need for a preventive treatment to handle accidental gluten exposure.
What was built
A purified, single-enzyme endoprotease (E40) produced by a patented strain that degrades gluten in both the stomach and intestine.
Who needs this
Who can put this to work
If you are a supplement manufacturer dealing with the high cost and difficulty of strict Gluten Free Diets — this project developed a purified enzyme that reduces residual gluten to under 20ppm. This allows sufferers to manage accidental exposure more safely.
If you are a healthcare provider dealing with the high cost of treating Celiac Disease and NCGS — this project developed a preventive treatment that reduces total healthcare costs. It improves patient quality of life by reducing anxiety and social isolation.
Quick answers
What is the cost advantage of E40?
E40 comprises a single enzyme, which results in a clear cost advantage compared to multi-enzyme alternatives.
How is the product produced at scale?
E40 is produced by an engineered, patented acidic Streptomyces lividans TK24 strain and is directly purified in its mature, functional form.
What is the IP status of the technology?
The technology utilizes a patented Streptomyces lividans TK24 strain for enzyme production.
What regulatory path is proposed for faster market entry?
The project suggests that E40 can be classified as a medical device, which would shorten the time to market and increase access.
What is the timeline for clinical validation?
The project period runs from 2023-06-01 to 2025-12-31, with Dose Range Finding studies already completed to prepare for upcoming clinical trials.
Who built it
The project is led by a single SME, Nemysis Limited from Ireland, which holds 100% of the industry ratio. This lean structure suggests a highly focused commercial drive, as the entire EU contribution of EUR 2,499,999 is directed toward a single entity's development of the E40 enzyme.
Contact Nemysis Limited in Ireland regarding E40 licensing
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