Celiac Disease Foundation focuses on accelerating the pace of novel therapy development with targeted patient-centric recruitment for clinical trials.

LOS ANGELESOct. 7, 2020 /PRNewswire/ — Building on its role as the nation’s leading celiac disease patient advocacy organization and the largest nonprofit patient recruiter for celiac disease clinical trials and studies, the Celiac Disease Foundation is pleased to announce its partnership with Provention Bio, Inc. (Nasdaq: PRVB), to provide clinical trial recruitment for the biopharmaceutical company’s Phase 2b PROACTIVE (PROvention Amgen Celiac ProtecTIVE) Celiac Study testing the safety and effects of PRV-015 (an anti-interleukin-15 monoclonal antibody).

Utilizing the Celiac Disease Foundation’s full suite of patient recruitment services, including the iQualifyCeliac screening and call center platform, brand strategy, marketing campaign and website development, and digital patient recruitment, the PROACTIVE Celiac Study will enroll 220 adults with celiac disease who continue to experience symptoms while following a gluten-free diet.

In August 2020, the PROACTIVE Celiac Study began enrolling patients in the United States, with plans to launch recruitment in Canada later this year.

PRV-015 is designed to block interleukin-15, a cytokine that plays a central role in celiac disease, creating inflammation and intestinal damage. In combination with a gluten-free diet, PRV-015 aims to reduce symptoms and intestinal inflammation caused by accidental gluten exposure.

“PRV-015 could be the first-ever approved therapeutic for celiac disease,” stated Doug Jacobstein, Vice President, Clinical Development and Clinical Lead for the PROACTIVE Celiac Study at Provention Bio. “In previous clinical studies, PRV-015 has shown simultaneous reduction in gluten-induced symptoms and markers of intestinal inflammation as compared to placebo. We look forward to continuing our work with this investigational candidate, as we seek to bring forward therapies designed to intercept or prevent immune-mediated diseases.”

Marilyn G. Geller, CEO of the Celiac Disease Foundation, stated, “Patient recruitment is a central element in our efforts to accelerate research to develop treatments and a cure for celiac disease. With our established trust in the celiac patient community, we are pleased to offer our biopharmaceutical partners proven, cost-effective services to ensure the success of clinical trial patient outreach and enrollment.”

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About Celiac Disease
Celiac disease is a serious autoimmune disorder affecting an estimated 3 million Americans, of whom only 20-30% have been correctly diagnosed. A peer-reviewed research study by the Celiac Disease Foundation and Columbia University has documented the ineffectiveness of the gluten-free diet for a sizable percentage of diagnosed patients, forcing patients to live with a host of debilitating symptoms. Data from the Foundation’s iCureCeliac®, the nation’s celiac disease patient registry, continues to demonstrate patient need for adjunct treatments to a gluten-free diet.

About Celiac Disease Foundation
Founded in 1990, the Celiac Disease Foundation is the nation’s leading patient advocacy organization dedicated to accelerating the diagnosis and treatment of celiac disease. Through strategic investments in research, advocacy, and education, the Celiac Disease Foundation seeks to improve the quality of life for the more than 3 million individuals in the United States affected by this chronic, immune-mediated disease. Hosting the iCureCeliac® patient registry and offering robust patient recruitment services, the Celiac Disease Foundation targets patient candidates to speed enrollment and improve trial retention to drive discoveries that may lead to better treatments, and ultimately, a cure. For more information please visit celiac.org.

Celiac Disease Foundation Partners with Provention Bio on Its Phase 2b Study of Celiac Disease Therapeutic PRV-015