Prometheus Launches New Indication for PredictrPK® IFX, A Precision-Guided Dosing Test for IBD

• PredictrPK IFX is now available for both the induction and maintenance phases of infliximab (IFX) therapy for inflammatory bowel disease (IBD) patients
• PredictrPK IFX addresses the unmet need of personalized early IFX optimization to support therapeutic response, drug durability and sustained remission
• Recently published performance data for PredictrPK IFX demonstrates the accuracy of forecasted IFX concentrations, supporting the role of testing to optimize therapy

SAN DIEGO, March 2, 2023 /PRNewswire/ -- Prometheus Laboratories Inc. ("Prometheus"), a leader in precision healthcare, announced the launch of an induction-phase indication for PredictrPK IFX, a precision-guided dosing test. This expands PredictrPK IFX availability during both the induction and maintenance phases of IFX therapy for patients with IBD. The test first became available to providers in 2022 to optimize dosing during the maintenance phase of IFX therapy in support of improving clinical response rates and overall drug durability.

Anti-TNFs, such as IFX, are often first-line therapies for patients with moderate to severe disease and have revolutionized the treatment of IBD. However, up to 40% of patients fail to respond to initial IFX induction and up to 50% of initial responders experience treatment failure within the first year. Interpatient variability, unoptimized dosing, and subtherapeutic drug exposure are often attributed as leading causes of failure.

Results from a prospective intervention trial published in Inflammatory Bowel Diseases, led by Marla Dubinsky, MD, Chief, Pediatric Gastroenterology and Nutrition, Icahn School of Medicine at Mount Sinai, and Co-Director of the Susan and Leonard Feinstein IBD Clinical Center, examined the impact of patient pharmacokinetics (PK) on individualized dosing during IFX induction and outcomes. "We identified timing of the fourth infusion with an IFX exposure of ≥10 µg/mL, as an independent predictor of drug durability and antibody-free survival at 52-weeks. Overall, 69% of patients required accelerated administration of the fourth infusion to achieve target IFX concentrations. This increased to 80% for a subset who underwent the on-label IFX induction protocol. These findings support the clinical utility of individualized, PK-based, optimization of IFX during induction and the value precision-guided dosing has to significantly improve the efficacy of a first-line biologic."

PredictrPK IFX addresses the unmet need to quickly assess a patient's PK profile to facilitate individualized precision-guided dosing of IFX. The test offers guidance to achieve target concentrations through dose escalation or de-escalation strategies. Performance data for PredictrPK was recently published in the Journal of Clinical Medicine. "The findings revealed an excellent correlation between forecasted and observed IFX trough concentrations providing physicians a window of opportunity to adjust dosing before suboptimal drug concentrations are experienced," said Thierry Dervieux, PharmD, PhD, DABCC, Chief Scientific Officer at Prometheus and co-author of the study.

The ability to individualize biologic dosing is poised to fundamentally shift the treatment paradigm in IBD. "The impact of individualized, precision-guided dosing on patient care and treatment outcomes cannot be overstated," commented Ayesha Fatima, MD, Associate Professor at the Oakland University William Beaumont School of Medicine and IBD Specialist at Beaumont Children's Hospital, Division of Pediatric Gastroenterology, Liver and Nutrition. "Precision-guided dosing not only expedites disease management, but facilitates conversations with both patients and medical plan providers regarding treatment goals and options."

About PredictrPK^® IFX
PredictrPK IFX is validated for adult and pediatric IBD patients receiving IFX or IFX biosimilars. Combining serology markers, patient- and disease-specific variables, current dosing, and a proprietary machine-learning algorithm, PredictrPK IFX provides individualized, actionable insights to support optimized dosing. PredictrPK Induction provides estimated IFX concentrations at 4-, 6-, and 8-weeks post dose three to aid in timing of the fourth infusion. PredictrPK Maintenance estimates IFX trough levels with the current dose and interval, and alternative dose and interval combinations. Both tests provide current IFX, antibodies-to-IFX (ATI) and albumin levels at the time of sample collection.

About Prometheus Laboratories
Prometheus Laboratories is a specialty clinical laboratory which enables precision-guided care in inflammatory bowel disease and other GI and autoimmune disorders. We discover, develop and commercialize testing that helps clinicians improve outcomes across the patient journey - from disease interception and stratification to therapy selection, optimization and monitoring.

For more information, visit Prometheuslabs.com and follow @Prometheuslab.

Drs Dubinsky and Fatima are paid consultants for Prometheus Laboratories.

SOURCE Prometheus Laboratories, Inc.

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