FNIH and PathAI Forge Partnership to Advance Mucosal Healing in Ulcerative Colitis Research

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PathAI, a leading provider of AI-powered pathology tools to advance precision medicine, is pleased to announce that the Foundation for the National Institute of Health's (FNIH) Biomarkers Consortium – Mucosal Healing in Ulcerative Colitis project team has selected PathAI to be its technology partner to further the study of mucosal healing, bring AI-assisted precision to disease assessment, and drive cutting-edge research to facilitate the development of new therapies for ulcerative colitis (UC), a disease affecting 1 to 2 million in the US alone.1, 2

“Ulcerative colitis is an increasingly prevalent chronic disease. The lack of standardized measurement and definition of mucosal healing poses a significant challenge for UC drug development, limiting treatment options for patients,” said James O’Leary, Director, Inflammation and Immunity at the FNIH. Though nearly 200 active clinical trials support on-going development of new treatments and therapies,3 no standard histological measure exists. “Through this collaborative project with PathAI, together we aim to establish a reproducible methodology for histological measurement of mucosal healing in UC treatment.”

PathAI’s groundbreaking AI product, AIM-HI UC (AI-based Measurement of Histological Index for Ulcerative Colitis), will serve as the exclusive platform for automated Geboes-based disease assessment for the consortium. This innovative approach will provide invaluable insights into mucosal healing, enabling better capture of true drug effect/signal-to-noise ratio for UC treatments. Furthermore, this partnership holds the potential to fuel biomarker development by unraveling the inflammatory microenvironment of ulcerative colitis.

The FNIH Biomarkers Consortium brings together eight prominent biopharmaceutical companies, two prominent disease area foundations, academic partners, and the FDA in an unprecedented effort to standardize and enhance disease assessment in the field of ulcerative colitis. By selecting PathAI as its technology partner, the consortium aims to leverage PathAI’s expertise in AI algorithms to achieve a more accurate and reproducible scoring of mucosal healing and provide improved prediction of long-term patient outcomes. The project will culminate in a common protocol and white paper that will be submitted to the FDA to influence regulatory guidance for future UC clinical trials.

“PathAI's algorithms will elevate our ability to investigate novel relationships, signatures, and biomarkers in UC” said Andy Beck, CEO of PathAI. “By embracing an AI-driven standardized approach, we increase accuracy and reduce scoring variability for therapeutic response assessment. We are excited to be part of this groundbreaking project, with the ultimate goal of accurately predicting long-term patient outcomes and driving industry-wide consensus.”

One distinguishing feature of AIM-HI UC is that it is built on exhaustive WSI tissue segmentation and cell classification models, providing a quantitative and objective basis for a normally subjective assessment. Compared to traditional pathologist scoring, AIM-HI UC has demonstrated higher accuracy in measuring critical Geboes metrics essential to histological healing, including GS2A, GS2B, and GS3.

AIM-HI UC is intended for research use only, not for use in diagnostic procedures, serving as a secondary and/or exploratory endpoint in clinical trials. It enables the identification of histologic remission (GS