In a groundbreaking effort to change the future of Crohn’s Disease, the INTERCEPT project has launched Europe’s first-ever trial using biomarkers aimed at preventing the symptomatic onset of the disease before it even begins. This multi-million Euro initiative funded by the Innovative Health Initiative Joint Undertaking (IHI JU) with a total budget of more than EUR 38 million for the next five years aims to transform Crohn’s Disease from an incurable condition to one that can be effectively managed and potentially halted before it even starts, improving the quality of life for millions globally.
Approximately three million people in Europe are affected by Inflammatory Bowel Disease (IBD) with an increasing incidence in children and young adults. In addition to the debilitating symptoms – such as diarrhoea, stomach pain and weight loss – patients also face increased risks of complications, including colon cancers, delayed growth in children and mental health challenges like depression. Crohn’s Disease, one of the most common forms of IBD, is chronic and incurable, with patients enduring waves of remission and flare-ups.
Despite major advances in medication and therapeutic treatments, remission is still far from a universal experience and there is a persistent treatment gap. Nearly 50% of patients require surgery within ten years of diagnosis and only a minority, around 10%, experience prolonged remission. This chronic condition presents a significant burden not only on individuals and their families but also on societal productivity and national health systems.
In other inflammatory conditions, such as Type 1 Diabetes and Rheumatoid Arthritis, biomarkers – measurable substances found in body fluids – can signal the presence of the earliest stages of the disease before it clinically manifests, enabling the potential for predicting who is at risk for developing these conditions. There is growing evidence that biomarkers could also be used to detect Crohn’s Disease in the preclinical phase long before symptoms develop. Candidate biomarkers have been developed for Crohn’s Disease but not yet validated across multiple populations.
This is where the newly launched INTERCEPT project steps up. In discussing the significance of the project, Prof Geert D’Haens, Project Coordinator from Stichting Amsterdam UMC (AUMC), stated: “We have been able to design this project due to our colleagues in North America laying the scientific foundation of predictive biomarkers for Crohn’s Disease. Although our field is somewhat behind Type 1 Diabetes and Rheumatoid Arthritis, we are confident that we have strong and reliable biomarkers and very safe treatments to offer.”
Awny Farajallah, MD, FACP, Chief Medical Officer at Takeda Pharmaceutical Company Limited, Industry Lead for INTERCEPT, continued: “Biomarkers are key to future research and have the potential to revolutionise the treatment landscape for IBD.”
The INTERCEPT project aims to verify and clinically validate a panel of biomarkers and build a blood risk score that can identify individuals with a high risk of developing Crohn’s Disease within five years after initial evaluation. The project will recruit 10,000 healthy first-degree relatives of individuals with Crohn’s Disease from seven European countries to further validate the biomarkers and risk score. From this group, 80 with the highest risk of developing Crohn’s Disease will take part in an innovative trial aimed at preventing full-blown disease development through an established and highly effective medical treatment.
This early detection and prevention method has the potential to revolutionise the way we understand and treat Crohn’s Disease. It would enable healthcare professionals to diagnose
the disease early on, potentially keeping it from progressing to debilitating stages. INTERCEPT is setting its sights on a future where Crohn’s Disease is highly manageable or even avoidable; committing itself to improving the lives of patients and their families.
To achieve this ambitious goal, 21 collaborative partners from Europe, North America and South Korea have joined forces. In discussing their role in the project and collaboration, Farajallah elaborated: “At Takeda, we are dedicated to improving IBD patient care and are excited to join forces with the Innovative Health Initiative with the aim of transforming the treatment of Crohn’s Disease. In intercepting Crohn’s Disease, we face complex scientific challenges that no one organisation can address alone. Our collaboration will unite public and private sector expertise and resources to more efficiently advance Crohn’s research and potentially benefit IBD patients.”
Prof Jean-Frédéric Colombel, Director of the Inflammatory Bowel Disease Center at Icahn School of Medicine at Mount Sinai in New York, USA and co-lead PI for INTERCEPT, said: “For the first time, researchers from multiple European countries, North America and South Korea are working together to predict and prevent Crohn’s Disease, reaching a milestone in the long path we began to walk many years ago. Our combined success would reinforce
the concept that immune-mediated diseases that not only affect the gut but also the joints, the skin and the brain can be prevented.”
INTERCEPT Project Coordinator D’Haens concluded: “I am honoured to lead this unique collaboration of bright scientists from across the European continent, North America and South Korea. It really feels like this may lead to the most significant scientific progress in the field since the initial description of the disease by Burrill Crohn himself in 1932.”
