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First Celiac Disease Treatment Licensed and Set for Late-Stage Clinical Trials
Celiac.com 04/04/2016 - Any one eager to try the first approved treatment for celiac disease might not have to wait much longer.
Alba Therapeutics has announced that their celiac treatment, larazotide acetate, will enter the first Phase 3 clinical trials ever conducted in a celiac disease drug later this year.
Lorazotide acetate works by improving regulation of tight junctions in the bowel. In healthy people, these junctions remain closed except to shed dead cells, but in patients with celiac disease, gluten keeps tight junctions open, triggering an inflammatory reaction that eventually destroys the intestinal villi, tiny, finger-like projections in the small intestine that are essential for nutrient absorption.
Early research suggests larazotide acetate helps to keep the tight junctions closed when it's taken before a meal, thus stopping, or reducing the reaction and the resulting inflammation.
Larazotide acetate recently completed during phase 2b clinical trials for efficacy, safety and tolerability in 342 patients with celiac disease. Those trials showed larazotide acetate 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.
Alba has announced that Innovate Biopharmaceuticals Inc. has licensed all of Alba Therapeutics' assets related to larazotide acetate, and that larazotide acetate has been renamed INN-202.
If approved on schedule, INN-202 will become the first prescription medicine for treating celiac disease.
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BL-710 Wins Designation as EU Medical Device for Celiac Treatment
BL-7010, a non-absorbable, orally available co-polymer for the treatment of celiac disease, has received designation as Class IIb medical device in the European Union, according to manufacturer BioLineRx Ltd.... [READ MORE]
An Update on Every Celiac Disease Drug Currently in Development
Here's every celiac disease treatment currently in development in a single list:
ALV003, by Alvine Pharmaceuticals, is a combination of two enzymes that break down gluten before it can provoke an immune reaction.... [READ MORE]
Could Egg Yolks Hold the Key to Celiac Disease Treatment?
There are numerous pills, enzymes, and other products in development that are all designed to provide moderate protection against accidental gluten exposure to people with celiac disease to gluten-intolerance.... [READ MORE]
How Close Are New Celiac Disease Treatments?
Of course, a strict gluten free diet is still the only safe and effective treatment for celiac disease.... [READ MORE]
Jefferson Adams is a freelance writer living in San Francisco. His poems, essays and photographs have appeared in Antioch Review, Blue Mesa Review, CALIBAN, Hayden's Ferry Review, Huffington Post, the Mississippi Review, and Slate among others.
He is a member of both the National Writers Union, the International Federation of Journalists, and covers San Francisco Health News for Examiner.com.View all articles by Jefferson Adams