Dr. Falk Pharma GmbH and Zedira GmbH have announced successful completion of the phase 2a clinical trial of ZED1227, a direct-acting and specific inhibitor of tissue transglutaminase, in patients with celiac disease. The clinical trial demonstrated a substantial protective effect of the first-in-class drug candidate ZED1227 on the duodenal mucosa during a 6-week gluten challenge. The placebo controlled dose-finding study revealed that each of the three active dose groups met the primary endpoint: ZED1227 attenuated the gluten-induced mucosal damage as indicated by the villous height to crypt depth ratio. Compared to placebo, difference in duodenal mucosal injury reached statistical significance for all three doses. Moreover, ZED1227 protected from inflammation and yielded significantly improved patient reported outcome. Further, the oral compound was found to be safe and well tolerated. The results of the study were published on July 1st, 2021 in the New England Journal of Medicine.
Crown CRO assisted in conducting this proof-of-concept study which enrolled patients in several European countries including Germany, Finland, and Norway.
As we say at Crown: Together for a healthier future!