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Celiac Disease

Celiac Disease Treatment Licensed and Headed to Late-Stage Clinical Trials

stockwheatlabA promising treatment for celiac disease will enter Phase 3 clinical trials in late 2016. Photo: Thinkstock

Larazotide acetate, the compound that many hope holds the key to a future treatment for patients living with celiac disease, entered a new important phase on Feb. 29, 2016. It was announced that Innovate Biopharmaceuticals Inc. has licensed all of Alba Therapeutics’ assets related to larazotide acetate, and that the treatment would head to Phase 3 clinical trials – “the first ever conducted in celiac disease” – later this year.

The compound, used in a treatment that was recently evaluated during phase 2b clinical trials for its efficacy, safety and tolerability in 342 patients with celiac disease, has been renamed INN-202. The results of those trials? Larazotide acetate was shown to be safe and effective in a “real world setting” for celiac patients, according to Alba’s website.

The treatment is now headed to Phase 3 trials in “late 2016”, and has received “fast track” designation from the Food and Drug Administration. INN-202 has the potential to become the first medicine for treating celiac disease.

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“We are pleased to complete the agreement with Alba and are tremendously excited to start the final development of larazotide acetate for celiac disease, a high unmet medical need because the symptoms are painful and socially debilitating despite being on a gluten free diet,” said Chris Prior, CEO of Innovate.

Larazotide acetate helps regulate tight junctions, which are located in the bowel, and in healthy people remain closed except to shed dead cells. In patients with celiac disease, the presence of gluten causes the tight junctions to remain open, thus starting an inflammatory cascade that eventually destroys the intestinal villi, tiny, finger-like projections in the small intestine that are essential for the body to absorb nutrients. Early research suggests larazotide acetate helps to keep the tight junctions closed when it’s taken before a meal, thus reducing or stopping the domino effects of inflammation.

The compound would work as a support to the gluten-free diet. By taking it before a meal, the idea would be to minimize any effects of accidental gluten ingestion. Research shows that up to 65 percent of those with celiac disease on a gluten-free diet continue to be exposed to gluten.

“For the past 10 years, Alba has been working diligently to research and develop larazotide acetate for patients who have celiac disease. The celiac disease patient community and their gastroenterology physicians have been instrumental to the success of our research and work in this field,” said Wendy Perrow, CEO of Alba.

“There is a huge demand for adjunctive therapies from the celiac patient community, and I am happy to see larazotide acetate moving ahead with what will be the first Phase 3 trials ever conducted in celiac disease,” said Dr. Daniel Leffler, director of research at The Celiac Center at Beth Israel Deaconess Medical Center.

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