Pioneering EU-backed trial seeks biomarkers to prevent Crohn’s disease

BELGIUM – A pioneering clinical trial, supported by the EU and pharmaceutical company Takeda, aims to identify biomarkers that could predict the risk of developing Crohn’s disease, enabling early intervention to prevent symptoms from ever manifesting.

Known as the INTERCEPT study, this initiative is funded with €38 million (approximately US $40 million) over five years and is hailed as “the first-ever prevention and disease interception trial using biomarkers with the goal of transforming Crohn’s,” according to its organizers.

The trial focuses on applying predictive biomarkers to disease management by developing a “blood risk score” capable of identifying individuals at high risk of developing Crohn’s disease within five years of evaluation.

Although some biomarkers for Crohn’s risk have been identified, their potential has not yet been validated. INTERCEPT represents a critical step toward turning this vision into reality.

Similar biomarker-based prevention strategies are already more advanced in other diseases, such as type 1 diabetes and rheumatoid arthritis.

The INTERCEPT trial seeks to close that gap for Crohn’s disease by validating biomarkers identified through prior research.

Examples include proteins such as ITGAV, EpCAM, IL-18, SLAMF7, and IL-8, discovered by scientists from the IBD-Character Consortium, an international team conducting multi-omic studies in large prospective inflammatory bowel disease (IBD) populations.

To achieve its goals, INTERCEPT will recruit 10,000 healthy first-degree relatives of individuals with Crohn’s disease from seven European countries.

Among these, 80 participants at the highest risk of developing symptomatic Crohn’s will be selected for a trial to test whether early treatment can prevent full-blown disease.

A coalition of 21 organizations from Europe, North America, and South Korea, operating under the EU’s Innovative Health Initiative (IHI) public-private partnership, emphasized the urgency of tackling Crohn’s disease.

Currently, around three million people in Europe suffer from IBD, experiencing debilitating symptoms such as diarrhea, abdominal pain, weight loss, and an increased risk of colon cancer and other complications.

Despite significant therapeutic advances, such as Takeda’s integrin inhibitor Entyvio (vedolizumab), launched nearly a decade ago, achieving remission remains a challenge.

Nearly half of Crohn’s patients require surgery within 10 years of diagnosis, and only about 10% achieve long-term remission.

“Biomarkers are key to future research and have the potential to revolutionize the treatment landscape for IBD,” remarked Awny Farajallah, Takeda’s Chief Medical Officer.