Alba reaches goal in celiac trial

Alba’s study, the first phase IIa trial in celiac disease (CD) and the first to assess dosing requirements for AT-1001 in CD, was designed to evaluate the safety, tolerability and efficacy of multiple doses of AT-1001 in CD subjects during a 2-week gluten challenge.

The randomized, double-blind, placebo-controlled clinical trial enrolled 86 patients who were confirmed biopsy positive for CD and in compliance with a gluten-free diet for at least six months prior to enrollment. Patients were randomized into seven drug-treated and placebo groups and challenged three times a day with gluten during a 14-day period.

Four doses of the enteric coated oral formulation of AT-1001, all less than 10 mg, were given prior to each gluten challenge. Study endpoints included intestinal permeability – a marker of disease state in CD – as well as patient symptoms and outcomes.

Patients on the AT-1001 drug performed better than those on the gluten/placebo arm and analyses demonstrated that several symptoms and outcomes improved at statistically significant levels. Safety and tolerability of multiple oral doses of AT-1001 in the patient population was demonstrated, with no severe adverse events reported.

Based on these results, Alba said that it will advance AT-1001 into a phase IIb clinical study in CD subjects during the third quarter of 2007.