My two lives collided last week – and I should have mentioned it then, but you know how busy things are at the moment …
In my other life, I comment on corporate websites, and as part of that role, learned that Shire (a FTSE 100 bio-pharmaceutical company here in the UK) have bought rights to a celiac disease medicine from Alba Therapeutics Corp.
They’re paying $25m for up-front rights to market the product outside the US and Japan. The product (AT-1001) is in mid-stage phase II clinical trials using 140 coeliacs undergoing a gluten challenge, and is being developed for coeliac disease, though Shire say that they also have rights to develop it as a medicine for Crohn’s.
Back in May, Alba announced the results of their Phase IIa trial, which involved giving patients (biopsy positive, at least six months gluten free) gluten three times a day for fourteen days. They were also given four doses of AT-1001 before each gluten challenge, and then symptoms – and intestinal permeability – were monitored. Patients who received both gluten and AT-1001 did better than those receiving gluten and a placebo. Because this IIa trial went well, they moved on to a phase IIb trial in September, involving a six-week gluten challenge.
In 2008, they plan to test on newly diagnosed adults, and on adults who are unable to follow a gluten free diet. At some point, they will also test on children.
What does AT-1001 do?
The problem seems to be that in people with coeliac disease, the space between the cells lining the inner walls of the small intestine is too wide, making the lining more permeable, and allowing the large gluten proteins to slip into the lining. This stimulates the immune system, causing chronic inflammation and damaging the villi – with the results that we all know about.
AT-1001 is designed to prevent the lining becoming too permeable, which should, in turn reduce the inflammation and damage to the villi.
Definitely something to watch. Shire obviously think they’re onto a winner here …