PredictImmune PROFILE trial recruits over 200 patients

The first biomarker stratified study for Crohn’s disease, funded by Wellcome Trust, reaches its half way mark

Cambridge, UK, 07 January: PredictImmune, developers of pioneering prognostic tools for guiding treatment options and improving patient outcomes in immune-mediated diseases, is pleased to confirm that its PROFILE trial has reached the half way mark in terms of recruitment, having secured over 200 patients.

Funded by Wellcome Trust as part of its translational grant award funding stream, the PROFILE trial is the first biomarker stratified study for Crohn’s disease and potentially immune-mediated diseases as a whole. The trial seeks to demonstrate that stratifying patients based on their risk of experiencing a frequently relapsing disease course, coupled with top-down or step-up treatment options, will result in improved outcomes. The approach is the first attempt at a more personalised approach to treating patients with Crohn’s disease and uses PredictImmune’s PredictSURE® IBD test as the basis for the risk-stratification of the patients.

The PROFILE trial opened for recruitment in December 2017 and aims to enrol 400 newly diagnosed patients with active Crohn’s disease (defined as those diagnosed within the last 6 months) from approximately 50 acute hospital trusts across the UK. The trial is currently open for recruitment at 44 sites, with additional sites still being accepted. The goal of the study is to dramatically reduce the impact of Crohn’s disease on the lives of future patients and is testament to PredictImmune’s vision to improve outcomes for patients with immune-mediated diseases.

Dr Miles Parkes, Chief Investigator, PROFILE trial commented: “I am delighted to see this important recruitment milestone reached. PROFILE is a ground-breaking trial – the first of its type in any inflammatory disease, evaluating a new test which we believe will predict the future behaviour of Crohn’s disease, and help clinicians to target the right treatment to the right patient from the beginning. This is an essential part of ‘personalised medicine’, and has the potential to dramatically improve outcomes for our patients. Recruiting to any research study is always a challenge, particularly when people have just received a diagnosis of Crohn’s disease.

“It is testament to the dedication of participating patients and hard work of all the research nurses and clinical teams who are helping to run the PROFILE trial that we have reached the half way mark.”

Paul Kinnon, CEO, PredictImmune added: “We are very pleased with the way the study is progressing and excited to demonstrate that the benefits of personalised medicine can be used to improve patient outcomes in Crohn’s disease and are not just confined to fields such as oncology. The PROFILE study is purely focussed on improved treatment and long-term wellness in Crohn’s patients, but this is the first step towards our wider objective of bringing significantly improved treatment and benefits to patients with a range of immune-mediated diseases.”

Helen Terry, Director of Research, Crohn’s & Colitis UK said: “We are determined that research involves patients every step of the way, so it’s fantastic that the PROFILE study has reached this significant milestone. We believe the future of Crohn’s and Colitis research is personalised and are

really excited that the PROFILE study and PredictSURE® IBD are working towards giving people with Crohn’s and Colitis the right treatment at the right time, the first time.”

To discover more about the PROFILE (Predicting Outcomes for Crohn’s Disease using a Molecular Biomarker) trial please visit:

When: 21st – 23rd October 2019 | Venue: Fira Barcelona Grand Via, Barcelona, Spain | Stand 86

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