ZED1227 attenuates gluten-induced duodenal mucosal damage among patients undergoing daily gluten challenge
THURSDAY, July 1, 2021 (HealthDay News) — For patients with celiac disease, treatment with a selective oral transglutaminase 2 inhibitor (ZED1227) attenuates gluten-induced duodenal mucosal damage, according to a study published in the July 1 issue of the New England Journal of Medicine.
Detlef Schuppan, M.D., Ph.D., from the Johannes Gutenberg University in Mainz, Germany, and colleagues conducted a proof-of-concept trial of a six-week treatment with ZED1227 at three dose levels versus placebo among adults with well-controlled celiac disease who underwent a daily gluten challenge. The primary end point of attenuation of gluten-induced mucosal damage was assessed among 35, 39, 38, and 30 patients assigned to 10-mg, 50-mg, and 100-mg ZED1227 and placebo, respectively.
The researchers found that at all three dose levels, ZED1227 treatment attenuated gluten-induced duodenal mucosal injury. From baseline to week six, the mean ratio of villus height to crypt depth estimated difference from placebo was 0.44, 0.49, and 0.48 in the 10-, 50-, and 100-mg groups, respectively. For the change in intraepithelial lymphocyte density, the estimated differences from placebo were −2.7, −4.2, and −9.6 cells per 100 epithelial cells, respectively, for 10-, 50-, and 100-mg ZED1227. Symptom and quality-of-life scores may have been improved with use of the 100-mg dose.
“Although this trial is very encouraging, whether treatment with ZED1227, and more generally transglutaminase 2 inhibition, in patients with celiac disease will be efficient in real life and during long-term gluten exposure remains to be determined,” writes the author of an accompanying editorial.
The study was funded by Dr. Falk Pharma, the manufacturer of ZED1227.
Editorial (subscription or payment may be required)
Copyright © 2021 HealthDay. All rights reserved.
