Larazotide: Phase IIb data

The double-blind, North American Phase IIb CLIN1001-012 trial in 342 celiac disease patients who have persistent symptoms despite being on a gluten-free diet showed that thrice-daily oral larazotide met the primary endpoint of improving the celiac disease domains of the gastrointestinal symptoms rating scale from baseline to week 12 vs. placebo. Patients received placebo or thrice-daily 0.5, 1 and 2 mg larazotide. Alba said it has started planning for Phase III trials with larazotide, but declined to disclose details. ...