Recombinant Glutenase Cuts Gluten-Induced Mucosal Injury
(HealthDay News) — A mixture of two recombinant gluten-specific proteases, ALV003, given orally can reduce gluten-induced small intestinal mucosal injury in patients with celiac disease, according to a study published in the June issue of Gastroenterology.
Marja-Leena Lähdeaho, M.D., from the Tampere University Hospital in Finland, and colleagues conducted a phase 2 trial to examine whether ALV003 given orally could protect patients with celiac disease from gluten-induced mucosal injury. The researchers selected a daily dose of 2g gluten for the intervention study. Adults with biopsy-proven celiac disease were randomized to receive ALV003 (16 patients) or placebo (18 patients). At baseline and after gluten challenges, they collected duodenal biopsies.
The researchers found that after the gluten challenge there was evidence of mucosal injury in biopsies from patients in the placebo group, but no significant deterioration was observed in biopsies from the ALV003 group. From baseline to week six, morphologic changes and CD3+ intraepithelial lymphocyte counts differed significantly between the groups (P=0.0133 and 0.0123, respectively). There were no significant between-group differences in symptoms.
"The glutenase ALV003 appears to attenuate gluten-induced small intestinal mucosal injury in patients with celiac disease in the context of an everyday gluten-free diet containing daily up to 2g gluten," the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Alvine Pharmaceuticals, which funded the study and manufactures glutenase ALV003.