Takeda backs biomarker trial for Crohn's prevention
INTERCEPT trial team at a meeting in Vienna.
A pioneering clinical trial backed by the EU and drugmaker Takeda will look for biomarkers that could be used to identify people at risk of developing Crohn's disease in the hope of intervening early on to prevent symptoms ever developing.
The INTERCEPT study is being funded to the tune of €38 million (nearly $40 million) over the next five years and is described as "the first-ever prevention and disease interception trial using biomarkers with the goal of transforming Crohn's," a common form of inflammatory bowel disease.
It represents a major new drive to apply predictive biomarkers to the management of disease and will rely on the building of a 'blood risk score' that the study's organisers reckon could identify individuals with a high risk of developing Crohn's disease within five years after an initial evaluation.
Biomarkers that could be used in this way have been identified, but so far have not had their potential validated, making INTERCEPT an important step to making that vision a reality. The approach is more advanced in some other diseases, notably type 1 diabetes and rheumatoid arthritis, but this project aims to close the gap.
Examples of biomarkers that may be assessed include various proteins found in the blood, including ITGAV, EpCAM, IL-18, SLAMF7, and IL-8, which were discovered by scientists involved in the IBD-Character Consortium, an international group carrying out multi-omic studies in a large, prospective IBD population.
INTERCEPT will recruit 10,000 healthy first-degree relatives of individuals with Crohn's disease from seven European countries to validate biomarkers and risk score. Of these, 80 people at the highest risk of going on to develop symptomatic Crohn's will take part in a trial to see if full-blown disease can be prevented with treatment.
A statement from the 21 organisations in Europe, North American, and South Korea – brought together under the EU's Innovative Health Initiative (IHI) public-private-partnership to run the INTERCEPT trial – said that around three million people in Europe have IBD, causing debilitating symptoms like diarrhoea, pain, and weight loss, as well as raising the risk of colon cancers and other complications.
Despite major advances in therapies – including, for example, the launch of Takeda's first-in-class integrin inhibitor Entyvio (vedolizumab) around a decade ago – remission is still far from a universal experience, according to the group.
Even with treatment, nearly half of patients require surgery within 10 years of diagnosis and only a minority – around 10% – are able to achieve prolonged remission.
"Biomarkers are key to future research and have the potential to revolutionise the treatment landscape for IBD," remarked Awny Farajallah, Takeda's chief medical officer.
