AI-powered pathology firm Path AI has announced an expansion of its support of inflammatory bowel disease clinical trials.
The company has launched two new AI-powered tools for histology endpoint assessment on its AISight clinical trials platform; AIM-HI UC and IBDExplore, both for application in ulcerative colitis (UC) clinical trials.
This launch marks a significant milestone for drug developers, making these advanced AI solutions immediately available for seamless integration into clinical trial protocols as standardised, reproducible endpoints.
The AISight clinical trials platform provides a robust, GCP/GCLP-compliant environment that bridges the gap between traditional pathology and computational precision. By launching these tools on AISight Clinical Trials, PathAI enables biopharma partners to:
- Deploy AI-powered endpoints: easily integrate AI-driven histology scores into existing trial workflows to strengthen clinical data packages.
- Hybrid workflow support: the platform uniquely supports both manual histology reads and AI-powered computational reads in a single, unified interface.
- Seamless data flow: automated outputs are designed to be trial-ready, providing the scalability needed for global, multi-site studies.
While AIM-HI UC provides standardised, reproducible histologic scoring, IBDExplore (pictured above) transforms standard H&E-stained histology whole-slide images into rich maps of scalable, quantitative spatial insights. When integrated into clinical trial outputs as an exploratory endpoint, IBDExplore empowers researchers to uncover Mechanism of Action (MoA) and analyse cellular relationships and tissue architecture changes in response to therapy; as well as identify subtle nuances of response that traditional scoring might miss, providing a competitive edge in therapy positioning.
Both tools were developed in partnership with the Foundation for National Institutes of Health (FNIH) Biomarkers Consortium, which leads cross-sector efforts to validate and qualify biomarkers that accelerate the development of new therapeutics and health technologies. The Biomarkers Consortium Mucosal Healing in Ulcerative Colitis project team comprises eight life sciences companies, non-profit foundations, leading academic medical centres, world-renowned key opinion leaders, and regulatory representatives from the FDA, united with the goal of bringing standardised scoring and deeper biological insights to the UC community.
Life sciences leaders within the FNIH project team emphasise that these AI-driven tools provide a level of granularity that was previously unattainable through traditional methods. "The integration of AIM-HI UC and IBDExplore into the clinical trial landscape represents a paradigm shift in how we evaluate treatment efficacy and directly addresses the FNIH project team’s aim to bring standardisation to mucosal healing assessment," said Stephen Laroux, Director - Scientific Research Fellow, Precision Medicine and Immunology at AbbVie and co-chair of the FNIH Mucosal Healing in UC project team. "By leveraging AI to capture subtle histological nuances and spatial patterns that often go undetected by the human eye, we can achieve a more precise and objective understanding of mucosal healing. This technology doesn't just replicate existing scores; it uncovers insights that help us better differentiate therapeutic impact for patients."
Echoing the importance of these advancements, Andy Beck, CEO at PathAI commented: "The launch of both IBDExplore and AIM-HI UC on the AISight Clinical Trials platform transforms how we measure success in ulcerative colitis trials. By moving toward deeper insights and automated, reproducible histology, we aren't just improving data quality, we are accelerating the delivery of life-changing treatments to patients."
IBDExplore, AIM-HI UC, and AISight Clinical Trials Platform are For Research Use Only. Not for use in diagnostic procedures.