Extra funding
The AMC has been awarded funding for the rapid targeted methylation assay development and partial funding for the clinical validation trial through a Horizon Europe grant award. Therefore, AMC also seeked co-funding from Helmsley Charitable Trust to close the gap in funding for the clinical validation trial. In 2023 funding was granted by Helmsley to support the following clinical validation trial activities:
- Project site and data management that is aligned with the strict regulatory agency standards to allow the future submission of the trial data and analysis for regulatory approval of the assay.
- Central reading of endoscopies to enhance the overall quality of the trial.
- Training, quality control, and central reading for intestinal ultrasound (IUS) in one-third of trial participants. IUS transmural healing will be an exploratory outcome for the proposed trial.
- Processing of biopsy samples and central histology reading for analysis of disease activity.
- Recruitment boosting activities across the countries of the participating clinical sites including remittance of investigator participation fees, site staff training, periodic trial newsletters, and a national kick-off and two national site meetings of the investigators.
- Trial oversight, scientific support, and medical writing for clinical trial reports and publications.
Background information
There is an urgent need to develop biomarkers that are predictive of a Crohn’s Disease patient’s response to biologic therapies. If successful, this project will clinically validate a rapid targeted methylation marker blood test for the selection of the biologics adalimumab, vedolizumab and ustekinumab that has the highest likelihood of providing effective treatment for an individual Crohn’s Disease patient, decreasing the potential for delays in effective treatment and improving outcomes for Crohn’s Disease patients. Furthermore, the proposed study is designed to meet the criteria for future submission of the validated predictive assay for regulatory agency approval and therefore paves the way for the critical future steps that will be required to bring this potentially valuable tool into clinical practice.