Dr. Falk Pharma GmbH and Zedira GmbH are announcing the start of a phase 2a clinical trial of tissue transglutaminase inhibitor ZED1227 in patients with non-alcoholic fatty liver disease (NAFLD). The study plans to enroll 160 patients in several European countries including Germany, France, and Spain. The first patient was enrolled into the study in April 2022. This placebo-controlled dose-finding study will evaluate the efficacy and tolerability of ZED1227 in patients with NAFLD with significant fibrosis.

Following the successful completion of a phase 2a study of ZED1227 in patients with celiac disease (N Engl J Med 2021;385:35-45. DOI: 10.1056/NEJMoa2032441), Dr. Falk Pharma and Zedira decided to expand its testing to NAFLD, a hepatological disease with high unmet need for effective therapies.

Non-alcoholic fatty liver disease is the most common cause of chronic liver disease in Western countries. With an increasing prevalence of about 25% worldwide, interest in NAFLD has grown in recent years. Patients with advanced fibrosis are at a high risk of developing severe liver disease, generating a high need for medical therapy. To date, no pharmaceutical has been approved for the treatment of NAFLD or its more rapidly-progressive subtype, non-alcoholic steatohepatitis (NASH). Instead, dietary modifications and lifestyle changes are currently the only available and recommended therapeutic options for managing these diseases. Because progression of liver fibrosis is associated with a higher risk of clinical disease progression, improving liver fibrosis is crucial for patients’ health.

ZED1227 (Cells 2022, 11(10), 1667; https://doi.org/10.3390/cells11101667) is a synthetic peptidomimetic compound designed by Zedira scientists to specifically inhibit the enzymatic activity of human tissue transglutaminase (TG2). Dr. Falk Pharma has acquired the licensing rights to ZED1227 in Europe and several non-European countries and has assumed responsibility for pharmaceutical, preclinical, and clinical development of the new chemical entity towards a pharmaceutical product.

By inhibiting TG2 in liver tissue, ZED1227 is expected to improve liver fibrosis in patients with NAFLD.
Following pre-clinical proof of concept testing, Dr. Falk Pharma and Zedira have initiated a phase 2a study to investigate the efficacy and safety of three doses of ZED1227 in patients with NAFLD with significant fibrosis. The results of this study are awaited in Q3 2023.

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