The aim of precision medicine is to tailor treatments to the specific clinical and biological characteristics of an individual patient’s disease. This requires the identification of biomarkers (genomic, proteomic, transcriptomic, and other biological markers) to help clinicians understand disease susceptibility and to predict an individual patient’s disease course and likely response to different treatments. Precision medicine is well established in fields like oncology and is now being explored in other disease areas, including inflammatory bowel disease (IBD).
IBD is a chronic incurable disease, and the primary treatment objectives are to induce prolonged remission and mucosal healing while minimising side effects from medication (e.g., severe infections due to immunosuppression). IBD is characterized by a heterogenous disease course that lends itself well to a precision medicine approach.
PredictImmune is a global biotechnology company applying innovative technology to the development of products to enable precision medicine in immune-mediated inflammatory diseases (IMIDs) such as Crohn’s Disease (CD), Multiple Sclerosis (MS) and Ulcerative Colitis (UC). In IMIDs, the disease course varies significantly from patient to patient, which makes it challenging to identify the best treatment strategy for individual patients, resulting in a ”one size fits all” approach to treating these diseases. A “Step-Up” approach (starting on less potent treatments and escalating in response to continued/renewed disease activity) risks under-treating patients likely to follow an aggressive disease course. Under-treatment can result in long-term damage and complications, such as the need for surgery. On the flip side, a “Top Down” approach (using aggressive therapies up front) risks overtreating patients with more quiescent disease, exposing them to unnecessary side effects such as an increased risk of infection.
The ability to identify patients at high risk of following an aggressive, frequently-relapsing disease course would enable doctors to craft a treatment plan that can control the symptoms that affect the gut and improve quality of life while minimising treatment side effects.
One of the major trends in the molecular diagnostics space is, therefore, the development of tools that facilitate prognosis: predicting long-term disease outcomes early in the course of the disease. Early prognosis leverages the precision medicine approach to the treatment of chronic diseases. PredictImmune’s award-winning product, PredictSURE® IBD, is the world’s first clinically validated and CE-marked prognostic test for ulcerative colitis and Crohn’s disease. PredictSURE IBD enables personalize treatment for patients diagnosed with inflammatory bowel diseases.
The world-class, blood-based transcriptomic biomarker test is based upon fifteen years of extensive research on gene expression profiling of CD8+ T-cells at Cambridge University. It is leading the way toward adopting a precision medicine approach for treating and managing IBD. The test results can be used in conjunction with clinical and lab tests that measure disease activity to guide the best treatment course.
To ensure global accessibility to its revolutionary product, PredictImmune is partnering with national and regional diagnostic laboratories to offer its prognostic test in its target markets. Its partner-centric business model utilizes partners’ local experience to scale its footprint at lower cost than a direct-to-market approach.
PredictImmune’s development and clinical trial activities are supported by top-tier academic institutions and charitable foundations such as Cambridge University (from whom they licensed the underlying technology), the Crohn’s and Colitis Foundation, Crohn and Colitis UK, and the Wellcome Trust .
PredictImmune has invested considerable time and resources to ensure the robust clinical validation of PredictSURE in independent cohorts. It has two ongoing clinical studies – the PROFILE Trial funded by the Wellcome Trust and the PRECIOUS Study, which is co-funded by the Crohn’s and Colitis Foundation.
The PROFILE trial is the first biomarker-stratified trial for Crohn’s disease. It recruited 390 recently diagnosed Crohn’s disease patients. PROFILE utilised PredictSURE IBD to stratify patients into high- and low-risk groups based on their risk of following a relapsing-remitting disease course. Both risk groups were randomized (50:50) into two treatment groups; Step-Up and Top-Down. The study seeks to demonstrate that tailored treatment guided by PredictSURE IBD can deliver better outcomes for patients. The results are expected in mid-2023. The PRECIOUS study will complement PredictImmune’s original UK-based clinical validation studies by demonstrating that PredictSURE IBD can reliably risk-stratify a more ethnically diverse North American IBD patient population.
“PredictSURE IBD can enable a step change in treatment strategy for IBD by supporting a precision medicine approach to help patients achieve prolonged remission early in the course of their disease,” said Aarti Gurnani, CEO of PredictImmune Limited. The company plans to build upon PredictSURE IBD and expand its product portfolio with other solutions to help patients with IMIDs manage their disease.
PredictImmune’s dedication to creating superior prognostic products to improve the quality of life of patients living with chronic illnesses has taken advantage of a window of opportunity in the field of precision medicine. Its mission and proven technology have undoubtedly driven its global presence in the field of IMIDs and will continue to do so.