First Licensed Celiac Treatment Heads to Phase 3 Trials

A drug to treat celiac disease could very well be just around the corner. Alba Therapeutics is on the FDA fast track, and we're here to share with you all of the details of this exciting development! 

Since celiac disease still continues to cause pain even for those on a strict gluten-free diet, there is a high demand for adjunctive therapies and treatment options. Enter Alba Therapeutics, who have developed a treatment for celiac disease that is the first to enter phase 3 clinical trials, and could be available before we know it. 

Who is Alba Therapeutics? 

Alba Therapeutics is a Maryland based biopharmaceutical company focused on the development of treatments for autoimmune and inflammatory diseases. They have decided to focus their research specifically on celiac disease, and for the past 10 years have been developing Larazotide Acetate, a compound aimed to help individuals with celiac disease by fighting leaky gut and other symptoms experienced due to gluten ingestion. Alba's multiple clinical trials have consistently demonstrated a reduction in symptoms of celiac disease in more than 800 patients. Alba has recently renamed the compound INN-202. 

What Exactly Does This Drug Do?

INN-202, or Larazotide Acetate, helps to regulate tight junctions, which are located in the bowel, and in healthy people remain closed except to shed dead cells. In individuals with celiac disease, the presence of gluten causes these tight junctions to remain open, thus leading to an inflammatory downward spiral of symptoms that eventually destroys the intestinal villi (tiny, finger-like projections that are crucial in aiding the body's absorption of vital nutrients). 

Alba Therapeutics' research suggests that larazotide acetate helps to keep the tight junctions closed when taken before a meal, thus reducing or stopping the domino effect of symptoms and intestinal damage. 

Does This Mean We'll Be Able to Eat Gluten?

Unfortunately, the compound would work in conjunction with a gluten-free diet, not in place of it. By taking it before a meal, the idea would be to minimize any effects of accidental gluten ingestion. 

Research shows that up to 65% of those with celiac disease who are on a strict gluten-free diet continue to be exposed to and to suffer from accidental gluten exposure. Because the symptoms of gluten exposure can be so painful and socially debilitating, these types of treatments are especially important. 

When Will It Be Available? 

Alba has been designated by the FDA to have "fast track status," and is set to start phase 3 clinical trials in "late 2016." This makes INN-202 potentially the first treatment that will be available to the public to combat celiac disease. 

And what does phase 3 even mean? Basically, this is the final countdown. Alba has already passed the tests with flying colors regarding whether this drug works to treat symptoms of gluten exposure - now it's just some final rounds of safety tests and (fingers crossed) this product can be made available to the public.

This is very exciting news! We hope to bring you updates about Larazotide Acetate later on this year, as well as news regarding the other celiac treatments currently being developed.