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PredictImmune, a developer of prognostic tools to guide treatment of patients with immune-mediated diseases, announced today that it has been awarded £4.3m by the Wellcome Trust.

The funding will be used to support a prospective multi-centre clinical trial of its prognostic biomarker test for treatment guidance in Crohn’s disease, one of the major forms of inflammatory bowel disease. The study is sponsored by Cambridge University Hospital NHS Foundation Trust and the University of Cambridge. The trial is entitled Predicting Outcomes for Crohn’s disease using a Molecular Biomarker, “PROFILE” (www.crohnsprofiletrial.com).

The PredictImmune biomarker test was developed and validated in Crohn’s disease and ulcerative colitis patients by researchers at the Department of Medicine at the University of Cambridge, part-funded by Wellcome. A simple whole blood test based on genetic markers, it enables for the first time and at first diagnosis of disease, prediction of which course a patient’s illness will take and, therefore, identification of patients likely to experience a severe, relapsing form of disease.

Patients likely to suffer from more severe disease have been shown, in other studies, to benefit from first line treatment with state-of-the-art biologic immunomodulator drugs, which are usually reserved for use when other anti-inflammatory treatments have failed to prevent frequent relapse.   Prediction of the likely long term severity of Crohn’s disease at first diagnosis may help to avoid patient suffering caused by over- or under-treatment.

The PROFILE clinical trial is the third study to use the biological principles of the prognostic test. The PROFILE trial is designed to prospectively evaluate the test’s ability to guide treatment choice between standard so-called “step-up” therapy compared with first line use of biologic immunomodulator drugs, such as tumour necrosis factor (TNF) inhibitors, in a “top-down” protocol.

Andrew Sandham, Chairman, PredictImmune commented: “The investment from Wellcome allows us to take a very positive step forward in the development of this, our first product.  The efficient and effective management of Crohn’s disease is crucial to patients’ long-term well-being. This prognostic tool accurately identifies patients, at diagnosis, who are at risk of experiencing severe, relapsing disease and who are therefore likely to benefit from early biologics therapy.  When combined with current diagnostic procedures, this new test is designed to guide physicians in selecting a treatment protocol that is best suited for the patient’s predicted longer-term prognosis.”

PredictImmune raised £4.7m Series A equity funding in May 2017 led by Parkwalk Opportunities Fund with co-investment from Cambridge Enterprise and Wren Capital. The company is using these funds for commercial development of laboratory services and diagnostic kits for routine use in clinical gastroenterology in Europe and the United States.

Published studies indicate that there are likely to be significant clinical and economic benefits in the use of biomarker tests to guide first line treatment based on prognosis of disease course. PredictImmune is also in discussion with multinational pharmaceutical companies about potential use of the test in the stratification of patients for clinical studies of novel biologic immunomodulator drugs.