LOCI is a validation trial Leveraging pharmacogenomics to Optimise Choice of IBD therapy
Inflammatory Bowel Disease (IBD) is a chronic, incurable debilitating condition of the gastrointestinal tract. Australia has among the highest rates of IBD in the world, with approximately 200,000 Australians affected and an annual cost to society of over $4 billion. The incidence and compounding prevalence rates of IBD is rising globally
At present we have minimal data to predict which patients will respond to a therapy and no tools for clinicians to decide which treatment to pursue.
This research aims to innovate and optimise the delivery of IBD health-care
Bioengineered molecules work for some patients, but most do not respond, leading to many treatment switches and devastating impacts on their lives. There is up to 10.4-fold variation in gene expression of IBD drug targets among patients, with drastic effects on individual drug response.
We will develop a novel pharmacogenomic test to predict patient response to current IBD therapies using their genotype, enabling precision treatment choices.
We will utilise ‘population-level’ cellular data from our world-leading OneK1K study, which has revealed how genetics influence drug target expression at individual immune cell level. We will perform validation trials in collaboration with AIMs - an established national multicentre longitudinal prospective cohort IBD study. Validating the test in a NATA-accredited laboratory and developing practice use guidelines will improve translatability.
LOCI’s pharmacogenomic test will match patients with effective treatments, improving quality of life, and reducing hospital stays and workdays lost to illness.
This test will also assist clinicians who are currently prescribing off-label for many autoimmune disorders, and assist industry to de-risk their drug development pathway.
LOCI will:
- Develop predictive tests for IBD treatment outcomes, for biologic and small molecule agents, based on a patient’s genotype
- Perform clinical validation trials of the tests, monitor patient outcomes longitudinally
- Develop a companion diagnostic for genotyping patients with full regulatory approvals for clinical use
Team:
Our multidisciplinary CI team comprises experts in all project aspects, including leading genomics and IBD researchers (Powell, Hold, James, MacArthur, Hewitt, Wasinger), clinical experts (El-Omar, Leong, Connor, Ghaly, Paramsothy), data scientists (Kummerfeld), health economists (Boettiger), and genetic and pharmacogenomic pathologists (Galea, Berbic).
We are supported by patient advocacy groups (Crohn’s and Colitis Australia; Crohn’s Colitis Cure), peak bodies (Gastroenterological Society of Australia), and research bodies (ANZ IBD Consortium) and AIs who are world-renowned immunologists (Goodnow), and IBD genetics clinical researchers (Radford-Smith).
This research is supported by a grant from the Medical Research Future Fund: Genomics Health Futures Mission
