PathAI, a leading provider of AI-enabled pathology, today announced its partnership with GSK (LSE/NYSE: GSK) in HORIZON, a randomized Phase 2b clinical trial in nonalcoholic steatohepatitis (NASH) (NCT05583344). The study will measure improvements in liver histology with GSK4532990 compared to placebo in participants with NASH and advanced fibrosis. PathAI’s role will be to generate, digitize and analyze liver biopsy slides for central pathological evaluation in addition to AI-powered histological evaluation using PathAI’s AI-based Measurement of NASH Histology (AIM-NASH) tool1. AIM-NASH metrics will be included as exploratory endpoints in this study.
PathAI will provide kitting, logistics, laboratory, and analytical services to collect digitized H&E and Masson’s trichome data for both pathologist consensus assessment, enabled by PathAI’s Contributor Pathologist Network, and quantitative histological assessment, enabled by AIM-NASH to generate and analyze. This study will leverage PathAI’s full end-to-end anatomical pathology services through the PathAI Biopharma Lab in Memphis, TN. PathAI’s biopharmaceutical lab will receive and join biopsies from subjects, stain tissue sections, and create slides. The stained slides for each case are then scanned with a whole slide image scanner and uploaded to PathAI’s digital pathology viewer, AISight™, for assessment by pathologists and via AIM-NASH.
PathAI’s AIM-NASH product has been trained to recognize and quantify the key histological features of NASH, including those used to assess disease severity using the NASH Clinical Research Network’s standard grading system. The product provides slide-level scores for these functions, reflecting the standard FDA-cleared pathology workflow, in addition to providing an expanded range of quantitative, continuous functions and scores for research exploration.
“We are excited to begin this NASH study with our partners at GSK and we are confident that our novel AIM-NASH tool and end-to-end support in the NASH category will reduce the likelihood of a technical and regulatory success,” said Andy Beck, Chief Executive Officer and co-founder of PathAI. “With GSK’s focus on AI and machine learning and PathAI’s expertise in end-to-end AI-enhanced pathology, we believe this will be a fruitful collaboration and advance the field with the goal of improving NASH patients help.”