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Phase 2 study of AMG 714 for refractory celiac disease begins enrollment
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Celimmune has begun screening patients for its phase 2 clinical study of AMG 714, an anti-interleukin-15 monoclonal antibody in development for the treatment of refractory celiac disease Type II, also known as refractory sprue, according to a company press release.
AMG 714 (Celimmune) is a fully human immunoglobulin monoclonal antibody that binds to IL-15, which is believed to be responsible for generating aberrant and malignant intraepithelial lymphocytes in refractory celiac disease Type II (RCD-II). The agent was well tolerated by healthy participants and patients with rheumatoid arthritis or psoriasis in four prior clinical studies, according to the press release.
Francisco León
“We are pleased to have commenced patient screening in this unprecedented industry-sponsored clinical trial evaluating an experimental therapeutic in refractory celiac disease Type II, an in situ T cell lymphoma that appears in the intestine of certain individuals with celiac disease as a rare complication of years of exposure to gluten,” Francisco León, MD, PhD, CEO and Chief Medical Officer of Celimmune, said in the press release. “Refractory celiac disease Type II has been treated with cladribine and bone marrow transplants, but these approaches have a limited response rate and carry their own risks. AMG 714, which neutralizes a molecule believed to be a key driver of this disease, IL-15, is an exciting new experimental approach that could provide a treatment option for patients diagnosed with refractory celiac disease Type II.”
There is currently no approved treatment for RCD-II, which affects about one in every 200 patients with celiac disease, whose risk for enteropathy-associated T cell lymphoma increases to greater than 50%, and whose average survival is 3-10 years after diagnosis resulting from intractable diarrhea and/or high-grade lymphomas.
Leon and colleagues anticipate they will enroll 24 patients with confirmed RCD-II in this 20-week randomized, double blind, parallel-group study. Patients will receive IV AMG 714 or placebo every 2 weeks while adhering to a strict gluten-free diet, and efficacy will be evaluated by intestinal biopsies taken before and after treatment.
“In addition to this trial, we recently started screening patients in another phase 2 clinical study evaluating AMG 714 as a potential therapeutic for gluten-free diet, non-responsive celiac disease,” Leon added.
Disclosure: Leon is employed by Celimmune.