PathAI Announces Collaboration with GSK on NASH Phase 2b Clinical Trial

Part of Multi-year Partnership Focusing on Drug Development in NASH and Oncology 

BOSTON, March 30, 2023 /PRNewswire/ -- PathAI, a leading provider of AI-powered pathology, today announced its partnership with GSK (LSE/NYSE: GSK) on HORIZON, a randomized Phase 2b non-alcoholic steatohepatitis (NASH) clinical trial (NCT05583344). The trial will measure improvements in liver histology with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis. PathAI's role will be to generate, digitize, and analyze liver biopsy slides for central pathologist evaluation in addition to AI-powered histologic 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, lab and analytical services to generate and analyze digitized H&E and Masson's Trichome data for both pathologist consensus scoring, facilitated by PathAI's Contributor Pathologist Network, and quantitative histologic evaluation, enabled by AIM-NASH. This trial will utilize PathAI's full end-to-end anatomical pathology services through the PathAI Biopharma Lab, located in Memphis, TN. PathAI's biopharma lab will receive and accession trial subject biopsies, stain tissue sections, and create slides. The stained slides for each case will then be scanned using a whole slide image scanner and will be 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 detect and quantify key histological features of NASH, including those that are evaluated for disease severity assessment using the standard NASH Clinical Research Network scoring system. The product delivers slide-level scores for those features mirroring the standard, FDA-approved pathology workflow, in addition to delivering an extended range of quantitative, continuous features and scores for research exploration. 

"We are excited to embark on this NASH trial with our partners at GSK, and we are confident that our novel AIM-NASH tool, and our end-to-end support in the NASH category will greatly improve the probability of 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-powered pathology, we believe this will be a fruitful collaboration and will advance the field with the goal of benefiting NASH patients." 

This collaboration builds on PathAI and GSK's multi-year partnership to accelerate scientific research and drug development programs in NASH and oncology, announced earlier this year. 

About PathAI

PathAI is the only AI-focused technology company to provide comprehensive precision pathology solutions from wet lab services to algorithm deployment for clinical trials and diagnostic use. Their AI-powered models are rigorously trained and validated with data from more than 15 million annotations and are used to optimize the analysis of patient samples to improve diagnostic efficiency and accuracy, while also accelerating drug development. PathAI is headquartered in Boston, MA, and operates a CAP/CLIA-certified laboratory in Memphis, TN. For more information, please visit www.pathai.com.

About HORIZON Ph2b Study:

The purpose of this study (NCT05583344) is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced (F3) fibrosis. The study duration will be up to 76 weeks including the screening period. The treatment duration will be up to 52 weeks.

¹AIM-NASH is intended for research-use only. Not for use in diagnostic procedures.

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SOURCE PathAI