Beyond Celiac, the leading catalyst for a celiac disease cure in the United States, today announced it has partnered with Provention Bio, Inc. (Nasdaq: PRVB) to provide clinical trial recruitment for the biopharmaceutical company’s Phase 2b PROACTIVE (PROvention Amgen Celiac ProtecTIVE) study of PRV-015 (an anti-interleukin-15 monoclonal antibody). This novel approach to treating celiac disease is designed to block interleukin-15, a cytokine that plays a central role in celiac disease, creating inflammation and intestinal damage.
“At Beyond Celiac, we are the bridge between our celiac disease community and the researchers who are focused on finding answers to our challenges,” said Beyond Celiac CEO Alice Bast. “PRV-015 has shown promising results in earlier studies, making it a therapeutic candidate to watch for treatment in adult celiac disease patients not responding to a gluten-free diet. Our organization is committed to playing a vital role in supporting this and other important research that will move us closer to effective treatments and a cure.”
Provention Bio’s clinical trial is expected to enroll approximately 220 adults with non-responsive celiac disease and will use the expertise of Beyond Celiac for trial recruitment. Beyond Celiac draws on extensive knowledge of the celiac disease patient community to reach people who are interested in participating in clinical trials. Previous Research Symposiums have emphasized the need for clinical trial participation. Furthermore, Go Beyond Celiac, an online patient database launched in 2017, allows its thousands of users to participate in research by sharing their celiac disease stories and experiences and learn how to become involved in research studies such as the Phase 2b PROACTIVE study.
“Across the healthcare field, patients’ stories are shaping what researchers study and how they study it. Collaborating with biotechnology and pharmaceutical companies such as Provention Bio to unite them with patients is what will advance development of potential treatments and a cure,” added Bast.
Celiac disease is a serious genetic autoimmune disorder that affects an estimated 1 in 133 Americans, more than half of whom are still undiagnosed. The disease causes damage to the small intestine, resulting in debilitating symptoms, and if left untreated, can lead to serious long-term health problems including infertility and some types of cancer