PredictImmune and the Crohn’s & Colitis Foundation announce start of jointly-sponsored study to validate PredictSURE IBD™, 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 IBD™ biomarker.  PredictSURE IBD™ 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 IBD™ in a diverse US patient population.  

PredictSURE IBD™ 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 IBD™, throughout North America. Under that agreement, KSL will manage and facilitate the fulfilment of orders of PredictSURE IBD™, 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 IBD™ in France, Belgium, Luxembourg, Switzerland and the Maghreb countries.  Both these announcements follow in the wake of the successful launch of PredictSURE IBD™ in the UK and Ireland in April this year and all are further strides towards making PredictSURE IBD™ 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 IBD™ 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 IBD™ for patients in the US, we hope to advance the efforts that will allow each patient to determine his or her best treatment options.”

About PredictImmune

PredictImmune Ltd was created in early 2017 as a spin-out from the Department of Medicine, University of Cambridge, UK.  It is a new generation molecular diagnostics company offering a unique approach to the prognosis of immune-mediated diseases such as Inflammatory Bowel Disease (IBD), Lupus, Multiple Sclerosis etc.

PredictImmune is developing whole blood based prognostic assays that are simple, robust, RT- PCR based tests compatible with methods used routinely in clinical laboratories. We aim to be the first company to offer predictive tests in immune-mediated diseases which will facilitate personalised treatment and thereby improve patient outcomes and health economics.

PredictImmune has just completed a £10m fund raising and has successfully launched its first test for IBD globally; it will be providing its proprietary technology as both a laboratory service and as a kit depending on the needs of global markets requirements.

PredictImmune’s mission is to improve patient treatment and outcome in these under served and chronic immune-mediated diseases by enabling clinicians to make the right decision at the time of diagnosis.

www.predictimmune.com

About the Crohn’s & Colitis Foundation

The Crohn's & Colitis Foundation is the leading non-profit organisation focused on both research and patient support for inflammatory bowel diseases (IBD). The Foundation’s mission is to cure Crohn's disease and ulcerative colitis, and to improve the quality of life for the estimated three million Americans living with IBD. For over 50 years, we have been inspiring and engaging patients and caregivers in the country’s largest IBD community and helping to dramatically accelerate the pace of research by breaking down traditional barriers to patients, data, funding, and collaborations. We also provide extensive educational resources for patients and their families, medical professionals, and the public. For more information, visit www.crohnscolitisfoundation.org, call 001-888-694-8872, or email info@crohnscolitisfoundation.org