PRV-015: A monoclonal antibody treatment in late-stage trials for celiac disease

November 2, 2021

Monoclonal antibodies can be used for treating many different types of disease and are being studied in celiac disease after showing proof-of-concept in earlier trials

by Kate Avery, MPH

Monoclonal antibodies have been in the news recently because there are several monoclonal antibody treatments with emergency authorization from the FDA for the treatment of COVID-19 infections. Monoclonal antibodies are man-made proteins that can bind to substances in the body. For COVID-19, the antibodies bind to the spike protein on the virus, which helps the body fight the infection.

Monoclonal antibodies are not just used to treat infections. They are also used to treat a number of autoimmune diseases, certain cancers, and gastrointestinal diseases.  Monoclonal antibodies are also being explored as potential celiac disease treatments. One example is PRV-015, a monoclonal antibody in Phase 2b clinical trials right now.

Monoclonal antibodies can treat autoimmune diseases by blocking cytokines. Cytokines are produced by the immune system and create inflammation. In people with celiac disease, cytokines are released with gluten consumption. These cytokines create inflammation and damage the small intestine, leading to symptoms. One of the key cytokines released that creates inflammation and damage is interleukin-15 (IL-15). PRV-015, being developed by Provention Bio and Amgen, is an anti-interleukin-15 antibody, meaning it may block IL-15 and its effects on the intestine. In a previous Phase 2a clinical trial in celiac disease, participants who received PRV-015 showed a reduction of the inflammation and symptoms triggered by gluten exposure.

PRV-015 is currently being studied in the PROACTIVEPhase 2b Celiac Disease Trial, which is ongoing across the US, Canada, Spain and the Netherlands. This is the last stage before the confirmatory Phase 3 study in a larger study population. If you are interested in learning more about the study, you can visit the website and fill out a survey to see if you qualify.

Beyond Celiac is helping to recruit for this study as part of our commitment to accelerating research into treatments and a cure for celiac disease.

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