Celimmune LLC, a clinical development-stage immunotherapy company focused on treating and preventing immune-mediated diseases, announced that it has dosed the first patient in its Phase 2 clinical study for AMG 714 in celiac disease.
AMG 714 is an investigational anti-IL-15 monoclonal antibody being studied for the treatment of gluten-free diet non-responsive celiac disease (NRCD) and refractory celiac disease Type II (RCD-II). The celiac disease study is being conducted by several expert academic medical centers in Tampere, Oulu, and Turku, Finland, a country where the incidence and understanding of celiac disease ranks among the highest in the world.
The randomized, double-blind, placebo-controlled, parallel-group study is expected to enroll 63 patients with a diagnosis of celiac disease confirmed by intestinal biopsy at least 12 months prior to screening. The study will evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge. Study duration is 20 weeks and visits to the site take place every two weeks.
Francisco Leon, M.D., Ph.D., CEO and Chief Medical Officer of Celimmune, commented, “Dosing the first celiac disease patient with AMG 714 is an important milestone for our company and an exciting step forward in the endeavor to find much-needed therapeutic treatment options for celiac disease when the gluten-free diet is not effective and for refractory celiac disease type II (RCD-II). We have chosen Finland for the excellence of its celiac research, its efficient clinical research community and its generous celiac patients, at the forefront of advancing the field.”
Markku Maki, professor and celiac disease researcher at Tampere University and University Hospital of Tampere, and an eminent figure in the field of celiac disease, commented, “AMG 714 is the first experimental therapeutic for celiac disease designed to block IL-15. We believe this approach to treating celiac disease has strong potential and look forward to continuing the enrollment of this study and evaluating the results to further our understanding of celiac disease.”
AMG 714 is a human immunoglobulin monoclonal antibody that binds to IL-15 and neutralizes its effects. IL-15 is considered to have a central role in celiac disease and to be a key driver of the generation of aberrant and malignant intraepithelial lymphocytes (IELs) in RCD-II. In four previous clinical studies, AMG 714 has been well tolerated by healthy volunteers, as well as by patients diagnosed with rheumatoid arthritis or psoriasis.
NRCD is defined as persistent symptoms, elevated celiac antibodies, or small intestinal damage following 6-12 months on a strict gluten-free diet. In most cases, NRCD is caused by unintentional gluten exposure from unrecognized gluten-containing products, such as foods believed to be, or labeled, gluten-free, or non-food products such as medications or household items (e.g. toothpaste, lipstick).