Crohn’s disease is 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.

PredictImmune’s biomarker test has been developed and validated in Crohn’s disease and ulcerative colitis patients by researchers at the Department of Medicine at the University of Cambridge, which was partly funded by Wellcome.

The company said a simple whole blood test based on genetic markers, it allows 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.

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

Studies have also shown that patients who are more likely to suffer from a severe form of the disease can benefit from the first line treatment with biologic immunomodulator drugs. These are generally used when other anti-inflammatory treatments have failed to prevent frequent relapse.

Predicting the likely long-term severity of Crohn’s disease at first diagnosis may help avoid patient’s suffering caused by over- or under-treatment.

PredictImmune executive chairman Andrew Sandham said: “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.”

In May 2017, PredictImmune raised £4.7m in series A equity funding led by Parkwalk Opportunities Fund with co-investment from Cambridge Enterprise and Wren Capital.