PredictImmune said today it is partnering with the Crohn’s & Colitis Foundation to jointly fund and launch a clinical study designed to validate the company’s PredictSURE IBD biomarker, which if approved would be the first prognostic test for inflammatory bowel disease (IBD) authorized in the U.S.
The PRECIOUS Study: Predicting Crohn’s and Colitis Outcomes in the United States (NCT03952364) is a multi-center, observational study of patients with active Crohn’s disease or ulcerative colitis, who are not receiving systemic steroids, immunomodulators or biologics. Up to 200 patients will be recruited from about 15 centers across the U.S., then classified at diagnosis into high-risk and low-risk cohorts using PredictSURE IBD.
The test stratifies patients based on their risk of subsequently experiencing a severe disease course, which is characterized by the requirement for multiple escalations in treatment due to frequently relapsing or chronically active disease.
“It’s exciting to get the PRECIOUS study underway, enabling us to extend our validation cohort and reinforce the utility of the test in delivering insights into the long-term disease course of IBD patients at the point of diagnosis,” PredictImmune CEO Paul Kinnon said in a statement. “The study takes both PredictImmune and the Crohn’s & Colitis Foundation a step closer to a common goal of improving disease outcomes and quality of life for patients with IBD in the US.”
In a tweet posted at 3:30 am ET, PredictImune added: “2 sites open & 4 patients recruited so far.”
Patients recruited by NYU Langone Health’s Bellevue Hospital Center are the first to join the study, which will track the progress of patients for up to 12 months following initial blood sample collection.
“There is a critical need for improved biomarkers in IBD to advance us toward precision medicine and improving patient care,” stated Caren Heller, MD, MBA, Chief Scientific Officer of the Crohn’s & Colitis Foundation. “The validation of the PredictSURE IBD biomarker in the U.S. would be a great step toward the goal of treating the right patient, with the right therapy, at the right time.”
Added Lea Ann Chen, MD, of NYU Langone Health, the principal investigator for the PRECIOUS Study: “In expanding the validation of PredictSURE IBD for patients in the U.S., we hope to advance the efforts that will allow each patient to determine his or her best treatment options.”
PredictSURE IBD is based on 10 years of research into gene expression profiling of CD8+ T cells by researchers at Prof. Ken Smith’s laboratory at the University of Cambridge.
PredictImmune successfully launched the test in the U.K. and Ireland in April, and since then has worked to expand the test’s distribution worldwide.
On October 22, PredictImmune said it entered into an exclusive commercial partnership with KSL Biomedical to promote and provide PredictSURE IBD, throughout North America. Under that agreement, whose value was not disclosed, KSL will manage and facilitate the fulfilment of orders of PredictSURE IBD, as well as receive and process all samples.
Six days later on October 28, PredictImmune and French diagnostic specialist Theradiag announced a strategic agreement to commercialize PredictSURE IBD in France, Belgium, Luxembourg, Switzerland and the Maghreb countries, which include Algeria, Libya, Morocco, and Tunisia. The value of that partnership was also not disclosed.