FNIH Biomarkers Consortium Project Will Transform Clinical Trials for Ulcerative Colitis

April 13, 2021 — The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium has launched a new project that will establish a common and harmonized methodology to define and measure healing in ulcerative colitis (UC). 

UC is a chronic, debilitating inflammatory bowel disease posing long-term complications, including perforations; severe bleeding; and increased risk of colon cancer, bone loss and vitamin or mineral deficiencies. While the factors that lead to UC are not well-understood, UC is known to damage the mucous membrane (mucosa) lining the rectum or colon and causes long-lasting ulcers in the digestive tract. The ability to define healing of the damaged mucosa— “mucosal healing”— requires a clear understanding of the progression through stages of disease that is not currently possible due to the lack of community consensus on the microscopic cellular characteristics of the diseased tissue (histology). 

This project, launched under the Biomarkers Consortium Inflammation and Immunity Steering Committee, will improve and standardize how the disease stage is determined and will allow for confident treatment decisions about diagnosis and disease progression (or remission in healing). 

The ideal therapeutic for UC would promote the healing of the damaged tissue or mucosal healing. In 2016, the U.S. Food and Drug Administration (FDA) issued guidance that encouraged the microscopic cellular evaluation of tissue in UC, to better inform patient treatment choices for improved quality of life. The project team, which includes leading academic and government experts in the field of UC, pharmaceutical industry partners and patient advocacy organizations, plans to work closely with regulatory agencies to design an evaluation system and enhance guidance around clinical trials for UC. Ultimately, the work generated from this project will pave the way for improved drug trials and better treatment options for patients with this painful chronic disease.

For more information about the project, click here.

Public Partners:

  • U.S. Food and Drug Administration

Private partners:

  • AbbVie, Inc*
  • Boehringer Ingelheim International GmbH*
  • Bristol Myers Squibb *
  • Crohn's & Colitis Foundation*
  • Eli Lilly and Company*
  • Janssen Research & Development, LLC*
  • Kenneth Rainin Foundation*
  • Pfizer, Inc*
  • Regeneron Pharmaceuticals*
  • Takeda Pharmaceutical Company Limited (Takeda)*

Academic partners: 

  • Icahn School of Medicine - Mount Sinai Health System
  • University of Oxford
  • Western University & London Health Science Centre

*Provided financial or in-kind support for this program.

Read what the partners are saying.

FNIH Contact

Tiffany Mercado, M.S., Scientific Project Manager, tmercado@fnih.org