October 27, 2011 — A prescription drug currently in development for celiac disease that would help to break down gluten before it causes symptoms and intestinal damage shows "tremendous" potential, says celiac expert Dr. Peter Green, director of the Celiac Disease Center at Columbia University.
"The main group of patients we see are those with ongoing symptoms, usually associated with ongoing villous atrophy," Dr. Green said in a conference call Oct. 27 to discuss testing results for Alvine Pharmaceuticals' drug ALV003.
"This is very exciting. I think, based on the study just presented ... the promise is just tremendous. We've all been waiting expectantly, looking for a potential therapy. There's a potential for the use of this drug in all sorts of subsets of celiac disease patients," Dr. Green said.
- Learn more: Celiac Disease Drugs in Development
ALV003 is an enzyme-based drug designed to degrade gluten molecules "in vitro" — i.e., in your stomach — into smaller pieces that will not cause symptoms.
The drug isn't designed to allow people with celiac disease to eat all the gluten they want; instead, it potentially would allow celiacs to avoid ongoing damage and symptoms from the tiny amounts of gluten we already consume on a daily basis. As such, it's considered an adjunct to the gluten-free diet, not a replacement of the diet.
Earlier this month, Alvine Pharmaceuticals announced it had achieved "clinical proof of principle" in its Phase 2a trial. In the Oct. 27 conference call, Alvine chief medical officer Dr. Daniel Adelman elaborated on those results.
According to Dr. Adelman, a total of 41 patients enrolled in the ALV003 trial, which was held in Finland. About half the group received ALV003 and half received a placebo. Everyone, meanwhile, ate gluten during the six-week trial — a total of two grams a day, or about half a slice of bread.
Virtually everyone in the trial entered with signs of ongoing inflammation due to accidental gluten consumption. At the end of the trial, however, the patients taking ALV003 while eating gluten weren't any worse, while the patients taking the placebo while eating gluten had significantly worse inflammation.
Although the trial wasn't designed to consider improvement in symptoms, those taking ALV003 seemed to have less indigestion and abdominal pain than those taking the placebo. However, patients taking the experimental drug didn't report any significant changes in diarrhea, constipation or reflux.
"ALV003, administered in the context of an everyday gluten-free diet, attenuates gluten-induced mucosal injury, as demonstrated in this rigorously conducted, controlled clinical trial," Dr. Adelman concluded.
Alvine Pharmaceuticals is proceeding with development of ALV003, and intends to begin a phase 2b trial in 2012, he said.
Since ALV003 won't allow people with celiac disease to consume tons of gluten, it's not the "cure" that many are seeking. However, if it truly does work to prevent symptoms and damage from ongoing gluten exposure, I think its developers will find it has a huge potential market in the celiac community.