Celiac disease is an autoimmune disorder in which the body destroys its own intestinal lining in response to the ingestion of gluten, a protein found in wheat, rye and barley. I previously discussed how Bob Anderson and his colleagues from the Walter and Eliza Hall Institute’s Celiac Center discovered the three specific peptides responsible for most celiac symptoms. Those same peptides have been used to develop an anti-celiac vaccine called Nexvax2®, which Anderson has been testing in a Phase I trial.
Phase I trials are designed to determine the safety and tolerability of a drug, as well as it’s bioactivity. Thus far, a group of celiac patients have been given weekly injections of Nexvax2® for three weeks. Although the patients were on a strict gluten-free diet, some of them experienced typical celiac symptoms at the highest doses of the drug. Patients also exhibited the desired T-cell response to the vaccine. In all, this indicates that the right peptides were chosen for the vaccine, and that it’s reasonably well tolerated.The next step (possibly beginning later this year) will be the Phase II trials, in which a larger group of patients receive the vaccine. Dosing and efficacy testing will continue during this phase. If those tests are promising, large scale Phase III testing will begin.