Larazotide Acetate and Celiac Disease

There is no cure for celiac disease. But, there is an experimental medication in Phase IIB testing, Larazotide Acetate, to be used along with a gluten-free diet.

Alessio Fasano University of Maryland Celiac Disease Alba Therapeutics

Alessio Fasano, MD. University of Maryland Celiac Disease Center

The investigational medicine, Larazotide Acetate, was developed by Alba Therapeutics. The experimental medicine has been used in Phase I and Phase II studies and currently being studied to determine how effective it is in different doses and whether side effects develop. Alba Therapeutics was co-founded by celiac disease researcher, Dr. Alessio Fasano, director of the Celiac Disease Center at the University of Maryland.1

The therapy is based on Dr. Fasano’s discovery that tight junctions between cells in the intestine can be opened or closed and that gluten relaxes these junctions. It is this process that leads to gluten improperly crossing into the body, thereby eliciting an immune reaction that leads to inflammation and damage characteristic of celiac disease.

“The reality is that the paracellular space is a gate, not a wall or fence. And if material gets through that space – even if it is only 1 to 5% of what normally travels through the cell – it could be associated with disease.”
-Alessio Fasano, MD1

Dr. Fasano discovered the potentially therapeutic utility of down-regulating intestinal permeability of celiac disease.1 In other words, he discovered that stopping tight junctions from inappropriately relaxing may be a way to treat celiac disease.

What Is Larazotide Acetate?

Larazotide acetate is a non-absorbed oral peptide and experimental medication which may improve intestinal lining barrier function by inhibiting cellular reorganization and closing tight junctions.2

It is taken by mouth, but stays in the gut and does not enter the body through the intestinal lining. While in the gut, it stops normally tight junctions between cells that line the small intestine from relaxing in the presence of gluten. Larazotide acetate is orally formulated (a capsule), has been granted “Fast Track” designation by the U.S. Food and Drug Administration for the treatment of Celiac disease.2

Larazotide Acetate is an experimental medication to be used in conjunction with a gluten-free diet. Basically, slip ups can happen and people can be inadvertently exposed to gluten. Larazotide Acetate is believed to minimize the damage such exposure would cause.1

A Phase IIB medical research study to test the effectiveness of various amounts of Larazotide Acetate in people with celiac disease is underway and signing up participants at CeliacTrial.com.

About the author

Author Information: John Libonati, Philadelphia, PA Publisher, Glutenfreeworks.com & The Gluten Free Works Health Guide. Editor & Publisher, Recognizing Celiac Disease.