On a different note than Wednesday’s alert, today’s post is about promising data on a drug for those of us with celiac disease.
The drug, currently carrying the less-than-sexy moniker ALV003, was designed by Alvine Pharmaceuticals to diminish, “gluten-induced intestinal mucosal injury in well-controlled celiac disease patients.” Phase 2a trials went well, hence this post.
Data from 34 celiac disease patients was included in the study; some patients were given the drug and others a placebo. All ingested 2g of gluten every day for six weeks. The group with the placebo reported higher incidence of “non-serious adverse events” (code for GI symptoms). They also had significantly more mucosal injury in their small intestines, as measured by biopsy data.
How does ALV003 work? The specifics are beyond me, but the basic info is that it breaks the gluten molecule down into nontoxic fragments. You can read more on Alvine’s website, as well as more about their other celiac-related in-process products.
To read the press release about these most recent findings, have a looksee here.
ALV003 will enter Phase 2b trials soon; after that come Phase 3 trials and (hopefully) submission to the FDA for approval.