I've just returned home after a trip to Baltimore for initial screening for a clinical drug trial. As it happened, after I provided my medical history I was excluded from the trial, so I won't be participating.
The trial is being conducted by a company named Parexel, and they are testing a drug that is currently called AT-1001 and is a product of a new pharmaceutical firm, Alba Therapeutics. This drug is based on the work of the world famous celiac expert, Dr Fassano, widely considered one of the most expert on celiac disease in the world.
The intended and hoped for final result of this study, still many years away, would be a drug that celiacs can take 3 times a day and then eat an unrestricted diet.
It is being conducted as a double-blind placebo controlled study. 2/3rds of those participating will be given the actual drug during a 3 day hospitalization, the remaining 1/3rd will be given a placebo. All of the study participants will be given a meal or a snack that contains undeclared gluten at some unannounced time during the study. Medical care will be immediately available to any study participant that may need it.
If this study proceeds as hoped, it is estimated that it will be 6 to 8 years until any drug might become available, and of course there is a lot more testing that would still need to be done after this test.
I did travel all the way from Palm Springs, CA to Baltimore to participate in this test, so I was willing. Unfortunately my current medical situation and my medical history were not a good fit for their test protocol.
Steve
