This drug would be used in conjunction with a Gluten Free diet to reduce Celiac Disease's "leaky gut" condition. "Leaky Gut" can also be described as intestinal permeability and is not only the cause of Celiac Disease issues but is also made worse by Celiac Disease. Two Clinical Trials have been conducted on this drug with promising results.
Trial 1 began in June 2007 and is still currently ongoing although not recruiting participants.
This study will look at 3 doses of AT1001 for efficacy and safety for the treatment of Celiac Disease. The primary efficacy outcome is to evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by a 6- week gluten challenge.
Trial 2 began in February 2008 and is currently still recruiting participants.
The purpose of this research study is to look at how effective and safe larazotide acetate (AT-1001) is when it is given to subjects who have active Celiac Disease. A "leaky gut" is often found in Celiac Disease patients, and it is thought that the leakiness contributes to the disease, possibly by letting more gluten enter the body. Larazotide acetate (AT-100l) is an experimental drug that may possibly reduce gut leakiness and is being investigated to see if it can help people with Celiac disease along with a gluten free diet.
In an October 8th, 2008 press release, Alba presented new data from the two clinical trials listed above at the 2008 American College of Gastroenterology Annual Scientific Meeting. They confirmed that their studies have shown that Larazotide Acetate Prevented Immunologic Changes Induced by Gluten in Patients with Celiac Disease. Larazotide acetate has the potential to become the first approved medicine to treat Celiac Disease and has been granted “Fast Track” designation from the U.S. Food and Drug Administration (FDA) for this indication. Both trials are in Phase II and expected to move to Phase III soon.
For more information about Alba Therapeutics and Larazotide acetate, see the following...
Click here for Alba's Web site