A stool test could tell doctors whether a patient with inflammatory bowel disease will benefit from biologic drugs before they are prescribed. Many patients with IBD who fail first-line treatments are put on biologic therapies, but a substantial fraction do not respond at all, and many who do respond initially lose that response over time. This trial-and-error process prolongs patient suffering and wastes healthcare resources. AlphaBiomics is developing RxSelex, a diagnostic that sequences microbial DNA from patient stool samples and uses machine learning to predict individual treatment outcomes. The resulting report would guide doctors and patients toward a personalised treatment plan from the start. If validated and adopted into NHS care, RxSelex could shift IBD management from a reactive, wasteful cycle of drug switching to a proactive, data-driven approach. For patients, that means fewer months of ineffective treatment and a faster path to symptom control. For the health system, it means reduced spending on expensive biologics that do not work for a given individual. The company aims to bring the product to NHS launch within a defined timeframe, with CE-marking and European rollout to follow.
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MEDICAL NEED: Clinical management of chronic diseases such as IBD is frequently inefficient, with few products to help physicians select personalized treatment strategies. In IBD, the bulk of patients who fail first line drugs are considered for biologics therapy, with most initially receiving anti-TNFα drugs, of which multiple generic versions are now in the formulary. However, up to 40% of patients do not respond to initial treatment. Among initial responders, 13%–46% lose response over the subsequent year. While physicians switch drugs aiming to find an effective long-term therapy, patients continue suffering and valuable healthcare resources are wasted. PROJECT VISION: To solve this issue, AlphaBiomics is developing RxSelex, a highly disruptive diagnostic that uniquely draws upon the immunomodulatory role of the microbiome and combines next-generation-sequencing of patient stool with machine learning to predict how patients will respond to biologics. The resulting RxSelex report guides the doctor and patient in selecting a personally optimized treatment plan. KEY OBJECTIVES: Funds are sought to validate AlphaBiomics RxSelex prediction model against two carefully curated and geographically distinct cohorts of 150 IBD patients each, collected by leading gastroenterology centres in the United Kingdom and the Netherlands. In addition, funds are requested to (i) validate RxSelex assay protocols, (ii) integrate the patient perspective and (iii) deploy commercial, IP and regulatory strategies for access to the NHS and other markets. IMPACT: Introducing RxSelex into the NHS care pathway will improve IBD patient outcomes, increase care efficiencies and offer compelling value for payers. Securing this funding will allow AlphaBiomics to bring RxSelex to within 12 months of NHS launch in 2022, with full CE-marked product expected to follow in 2023 for initial roll out in EU and then US markets.
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