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FDA Okays Celiac Disease Engineered Microbe Trial

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(fancycrave1, Pixabay)

19 Aug. 2019. A company making synthetic biological therapies received authorization to begin clinical trials in the U.S. for an engineered microbe to treat celiac disease. ActoBio Therapeutics Inc. in Ghent, Belgium says the U.S. Food and Drug Administration cleared its investigational new drug application, in effect giving permission to begin clinical trials of the company’s treatment for celiac disease code-named AG017.

Celiac disease is an inherited autoimmune disorder, where the body’s immune system reacts to gluten, a protein found in wheat, rye, and barley. The immune reaction destroys the nutrient absorption capacity of the small intestine, leading to tissue damage. About 1 percent of people worldwide have celiac disease, with the only protection against symptoms being a strict gluten-free diet. An estimated 2.5 million Americans, according to the Celiac Disease Foundation, have celiac disease, but are undiagnosed and at risk for long-term complications.

ActoBio Therapeutics, a subsidiary of Intrexon Corp. in Germantown, Maryland, develops treatments for disease that invoke the immune system. The company’s therapies use engineered forms of the natural bacterium, Lactococcus lactis, similar to microbes found in yogurt, to deliver protein therapeutics into the gut, which would otherwise degrade in the gastrointestinal tract. In this case, AG017 is designed to induce immune-system tolerance of gluten.

The company says AG017 alters the L. lactis bacterium to express a peptide, or short chain of amino acids, with gliadin, a protein similar to gluten found in wheat and other grains. AG017 also contains a cytokine, another peptide, for regulating the immune system response and reverse gluten sensitivity.

“We have demonstrated that this product is safe and efficacious in animal studies,” says Pieter Rottiers, CEO of ActoBio Therapeutics in a company statement. “Our approach with AG017 is to target the underlying cause of celiac disease, and this next stage of the program will allow us to evaluate how our preclinical results will translate in patients.” ActoBio expects to begin early- and mid-stage clinical trials in the U.S. and Europe later this year.

The company is developing a similar treatment for the autoimmune disease type 1 diabetes, code-named AG019, also designed to induce immune tolerance, in this case of insulin-producing beta cells. ActoBio says in tests with lab mice, AG019 combined with a synthetic targeted antibody induced reversion to normal blood sugar levels in 60 percent of the animals, and reversed the disease in 89% of mice treated in its early stages. AG019 is in an early- and mid-stage clinical trial as a treatment for early-onset type 1 diabetes.

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