By Van Waffle
Summary: ALV003 is an experimental drug that can break gluten proteins into small particles. Alvine Pharmaceuticals, based in California, has investigated it to treat celiac disease patients who remain sick despite following a gluten-free diet. To determine the safety and effectiveness of ALV003, a team of Finnish and American scientists conducted a phase II clinical trial in 47 patients who had followed a gluten-free diet for at least a year.
Every day for six weeks they consumed up to 6 grams of normal breadcrumbs and doses of either ALV003 or a placebo. A small number withdrew due to intolerable symptoms from the gluten challenge. The study assessed the response of those who continued by looking at intestinal health before and after the challenge. Tissue samples were analyzed for flattening of the villi and immune T-cells produced in response to gluten.
Conclusion: Patients taking a placebo rather than ALV003 showed increased damage in their gut tissue over the six-week study, while those taking the drug showed no significant change.
The authors recommend tissue biopsy as the most effective tool to evaluate other potential celiac disease therapies.
They found no adverse reaction to the drug itself. This is the first study to identify a drug that breaks down ingested gluten, reducing intestinal injury in celiac disease patients who consume gluten.
Now that it has worked in healthy celiac disease patients, the authors recommend testing for safety and effectiveness in people who continue to have symptoms despite following the gluten-free diet. A larger study would be necessary to determine whether ALV003 actually makes patients feel better, because the small study size prevented finding any statistical difference in symptoms such as cramps reported between the two groups.
[1] “The glutenase ALV003 attenuates gluten-induced mucosal injury in patients with celiac disease”, Lähdeaho M-L, Kaukinen K, Laurila K, Vuotikka P, Koivurova O-P, Kärjä-Lahdensuu T, Marcantonio A, Adelman DC, Mäki M, #Gastroenterology# (2014), doi: 10.1053/j.gastro.2014.02.031.
