The Idea

To date, mucosal healing should be the therapeutic goal in inflammatory bowel disease (IBD), as it is associated with sustained clinical remission, reduced rates of hospitalization and operations, as well as a lower incidence of colorectal cancer. We have developed the a multi-immune pathway biomarker test that identifies mucosal healing in IBD patients as early as 3-6 weeks following treatment initiation.

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The Technology

To address the various challenges in identifying fast and accurate endoscopic response in clinical practice, as well as the clinical development of novel Ulcerative colitis therapies, Kepler Diagnostics has developed the UCRI: a unitless multi-immune pathway biomarker test as a surrogate marker for endoscopic response. The UCRI is based on a solid analysis of more than then 10 different innate-immunity and inflammatory biomarkers from different immune pathways.

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Applications

• Ensure enrollment of an appropriate Ulcerative Colitis patient population

• Identify Ulcerative Colitis patients with high disease activity

• Use a simple blood test as a surrogate marker to detect endoscopic response to treatment in UC

• Detect endoscopic response within few weeks

• Use the UCRI for new therapeutic agent dose selection

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UCRI - Ulcerative Colitis Response Index Clinical study

Prospective multicenter trial to determine the efficacy and outcome of the UCRI in-vitro diagnostics device to detect treatment response measured by endoscopic healing in moderate to severe Ulcerative Colitis patients treated with Anti-TNF-a.  https://clinicaltrials.gov/ct2/show/NCT04897282

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Scientific Publications

•  Magali de Bruyn, Randy Ringold, Erik Martens, Marc Ferrante, Gert Van Assche, Ghislain Opdenakker, Avinoam Dukler, Séverine Vermeire, The Ulcerative Colitis Response Index for Detection of Mucosal Healing in Patients Treated With Anti-tumour Necrosis Factor, Journal of Crohn's and Colitis, Volume 14, Issue 2, February 2020, Pages 176–184, https://doi.org/10.1093/ecco-jcc/jjz125

• Serum Marker Panel for Detection of Mucosal Healing in Vedolizumab Treated Patients with Ulcerative Colitis Avinoam A. Dukler, Randy Ringold, Magali de Bruyn, Erik Martens,Marc Ferrante, Ghislain Opdenakker, and Severine Vermeire April 2019Gastroenterology 156(6):S-1136-S-1137

• Magali de Bruyn, Randy Ringold, Marc Ferrante, Gert A. Van Assche, Ghislain Opdenakker, Avinoam Dukler, Severine Vermeire, Serum Marker Panel for Detection of Mucosal Healing in Adalimumab Treated Patients with Ulcerative Colitis, Gastroenterology May 2018 154(6): S-600-S-601.

• M. de Bruyn et. al., OP007 Detection of mucosal healing with a serum marker panel in adalimumab-treated patients with ulcerative colitis , ECCO (2018) Oral Presentation

• Magali de Bruyn et. al., Serum Marker Panel for Early Detection of Endoscopic Healing with Infliximab in Patients with Ulcerative Colitis, Gastroenterology, 2017 Volume 152 , Issue 5 , S768.

• Diana Hoang-Ngoc Tran et. al., Circulating cathelicidin levels correlate with mucosal disease activity in ulcerative colitis, risk of intestinal stricture in Crohn’s disease, and clinical prognosis in inflammatory bowel disease, BMC Gastroenterology (2017) 17:63