November 13, 2008
Alba Therapeutics Initiates Enrollment in Phase IIb Celiac Disease Study
Alba Therapeutics, a clinical-stage biopharmaceutical company, has announced that for the first time, a European patient with active celiac disease has been enrolled in its clinical trial to investigate a treatment for the disease.
Alba has enrolled and randomized the newly diagnosed patient from Spain in an eight-week Phase IIb trial with oral larazotide acetate, a tight junction regulator, for the treatment of patients with active celiac disease (CD).
The global multi-center, randomized, double-blind, placebo-controlled study will evaluate the clinical and histological efficacy, safety and tolerability of larazotide acetate in 106 active CD subjects adhering to a gluten-free diet, while assessing improvement in the clinical signs and symptoms of celiac disease.
Francisco Leon, vice president of clinical development and medical affairs at Alba, said: "This is a major milestone for the celiac community in Europe. This is Alba's sixth human trial with larazotide acetate, and we are excited to be advancing our investigational program for larazotide acetate in this important region of the world."