PredictImmune has received a £4.3 million (US$5.85 million) grant to fund a prospective clinical trial to determine if its prognostic biomarker test can help personalize treatment strategies for patients with Crohn’s disease, a type of inflammatory bowel disease (IBD).

This funding is being provided by the Wellcome Trust, a nonprofit that supports health and medical research. The trial, titled “Predicting Outcomes for Crohn’s disease using a Molecular Biomarker” (PROFILE), is sponsored by Cambridge University Hospital NHS Foundation Trust and the University of Cambridge in the U.K.

PredictImmune’s prognostic test is based on a molecular signature detectable in CD8 T-cells, a specialized type of immune cell. It consists of a simple blood analysis for specific genetic markers of these cells, allowing both diagnosis and, for the first time, prediction of disease progression.

Using this test, patients with a higher chance of experiencing a severe, relapsing form of the disease can be identified early. Predicting long-term disease severity in Crohn’s patients may help reduce suffering caused by over- or under-treatment.

This prognostic test was already validated in patients with Crohn’s disease and ulcerative colitis. Several studies demonstrated the clinical and economic benefits of the biomarker test in determining first-line treatment based on prediction of the disease course.

The PROFILE trial is intended to evaluate the ability of the test to determine whether a patient would benefit more from standard “step-up” therapy or first-line treatment with biologic immunomodulatory medicines, such as tumor necrosis factor (TNF) inhibitors.

“The investment from Wellcome allows us to take a very positive step forward in the development of this, our first product,” Andrew Sandham, executive chairman of PredictImmune, said in a press release.

“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 combining 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 long-term prognosis,” he said.

PredictImmune is also negotiating with pharmaceutical companies to use this test in the stratification of patients for clinical trials involving biologic immunomodulatory medicines.

In May 2017, PredictImmune raised £4.7 million (US$6.38 million) through Parkwalk Opportunities Fund in collaboration with Cambridge Enterprise and Wren Capital. These funds are being used for the commercial development of diagnostic kits and laboratory services for use in clinical gastroenterology, both in Europe and the U.S.