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

Rhea-AI Summary

PathAI has partnered with GSK to conduct the HORIZON Phase 2b clinical trial targeting non-alcoholic steatohepatitis (NASH). This randomized trial will assess the efficacy of GSK4532990 on improving liver histology compared to placebo in patients with advanced fibrosis. PathAI will utilize its AIM-NASH tool for AI-driven histologic evaluation and provide comprehensive pathology services from biopsy analysis to lab services at its Memphis facility. The trial aims to last up to 76 weeks, with treatment lasting up to 52 weeks. This partnership builds on their existing collaboration focusing on drug development in NASH and oncology.

Positive

• PathAI's AIM-NASH tool is expected to enhance the evaluation process for liver histology.
• The HORIZON trial has clear endpoints and a structured timeline, potentially leading to valuable data for NASH treatment.
• The partnership indicates strong collaboration between PathAI and GSK, leveraging AI technology for improved drug development.

Negative

• None.

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.

Media Contact
Maggie Naples
SVM Public Relations
PathAI@svmpr.com 
(401) 490-9700 

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SOURCE PathAI

FAQ

What is the purpose of the GSK Phase 2b HORIZON clinical trial?

The trial aims to measure improvements in liver fibrosis and inflammation in NASH patients treated with GSK4532990 versus a placebo.

How long will the HORIZON Phase 2b trial last?

The study duration will be up to 76 weeks, including a screening period, with the treatment lasting up to 52 weeks.

What role does PathAI play in the GSK clinical trial?

PathAI will provide AI-powered pathology services, including the generation and analysis of liver biopsy slides using its AIM-NASH tool.

What technology does AIM-NASH utilize?

AIM-NASH is an AI-based tool designed to detect and quantify histological features of NASH, aiding in disease severity assessment.

What are the exploratory endpoints of the HORIZON trial?

The trial will include AIM-NASH metrics as exploratory endpoints to assess liver histology improvements.