PredictImmune and the Crohn’s & Colitis Foundation announce start of jointly- sponsored study to validate PredictSURE IBDTM, the first prognostic test for IBD, in the US market
The study gets underway with the first patients recruited at New York University/Bellevue the study’s first site in the United States
Cambridge, UK, 7 November 2019: PredictImmune, developers of pioneering prognostic tools for guiding treatment options and improving patient outcomes in immune-mediated diseases, today announced the start of the PRECIOUS (Predicting Crohn’s and Colitis Outcomes in the United States) study, which it is jointly funding with the Crohn’s & Colitis Foundation.
The PRECIOUS study is a multi-centre, observational study of patients with active Crohn’s disease or ulcerative colitis, who are not receiving systemic steroids, immunomodulators or biologics. The study will recruit up to 200 patients from about 15 centres across the US. The patients recruited by New York University/Bellevue are the first to join the study, which will continue to recruit. Patients’ progress will be tracked up for up to 12 months following initial blood sample collection.
PRECIOUS study patients will be classified at diagnosis into high-risk and low-risk cohorts using PredictImmune’s PredictSURE IBDTM biomarker. PredictSURE IBDTM stratifies patients based on their risk of subsequently experiencing a severe disease course, which is characterised by the requirement for multiple escalations in treatment due to frequently relapsing or chronically active disease. The study will provide important data towards validation of PredictSURE IBDTM in a diverse US patient population.
PredictSURE IBDTM is based on 10 years of extensive research into gene expression profiling of CD8+ T cells by researchers at Professor Ken Smith’s laboratory at the University of Cambridge, UK.
The start of the PRECIOUS study follows the recent announcement that PredictImmune has entered into an exclusive commercial partnership with KSL Biomedical (KSL), to promote and provide PredictSURE IBDTM, throughout North America. Under that agreement, KSL will manage and facilitate the fulfilment of orders of PredictSURE IBDTM, as well as receive and process all samples. The partnership with KSL in North America follows on from PredictImmune’s announcement of a strategic agreement with French diagnostic specialist, Theradiag, to commercialise PredictSURE IBDTM in France, Belgium, Luxembourg, Switzerland and the Maghreb countries. Both these announcements follow in the wake of the successful launch of PredictSURE IBDTM in the UK and Ireland in April this year and all are further strides towards making PredictSURE IBDTM available worldwide; enabling better patient treatment.
Paul Kinnon, CEO, PredictImmune commented of the study: “We see our partnership with the Crohn’s & Colitis Foundation as a positive step for both PredictImmune and IBD patients in the US. 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. 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.”
Caren Heller, MD, MBA, Chief Scientific Officer of the Crohn’s & Colitis Foundation, added: “There is a critical need for improved biomarkers in IBD to advance us toward precision medicine and improving patient care. The validation of the PredictSURE IBDTM biomarker in the US would be a great step toward the goal of treating the right patient, with the right therapy, at the right time.”
Lea Ann Chen, MD, PRECIOUS Study US PI also commented: “Personalised therapy is key to optimising outcomes and minimising risks for our patients with IBD. It is also dependent on having accurate predictors of disease behaviour. That is why we’re particularly excited to be a part of the PRECIOUS study. In expanding the validation of PredictSURE IBDTM for patients in the US, we hope to advance the efforts that will allow each patient to determine his or her best treatment options.”