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PathAI and Summit Clinical Research Launch a Comprehensive NASH Clinical Trial Services Solution to Optimize Trial Success

The collaboration provides sponsors with an innovative offering tailored to NASH sponsors featuring trial design, site activation and patient enrollment, wet lab, diagnostic, and AI-pathology deployment services.


September 22, 2021

For more information:

Isabella Canuso
609-682-1080
isabella.canuso@pathai.com

Boston, Massachusetts and San Antonio, Texas - PathAI, a global provider of artificial intelligence-powered (AI-powered) technology for pathology, and Summit Clinical Research, an integrated research organization that advises sponsors on Non-Alcoholic Steatohepatitis (NASH) clinical optimization, today announced a partnership offering an integrated solution to NASH drug developers in support of their clinical development programs. The collaboration builds on PathAI’s development of AI-powered tools for accurate, reproducible, and clinically relevant evaluation of liver pathology, as well as Summit’s expertise in NASH drug development and accelerated study execution.

Together, PathAI and Summit aim to alleviate many key challenges facing NASH drug development progress, including high site activation costs, barriers to subject enrollment, slow diagnostic turnaround time, and significant variability and inaccuracy in NASH histology scoring.

“Our joint offering with Summit combines next-generation, AI-powered drug development tools and best-in-class pathology to increase the probability of technical and regulatory success and bring much needed treatment options to patients,” explained Andy Beck MD, PhD, co-founder and CEO of PathAI. “We are very impressed by Summit’s global thought leadership across the liver disease treatment space, and are excited by our shared mission to improve patient outcomes at scale.”

The partnership leverages PathAI’s pathology services capabilities, including its recently acquired anatomic pathology lab capabilities in Poplar Healthcare, AI-based Measurement of NASH (AIM-NASH) drug development tool (DDT), and extensive network of expert liver pathologists qualified on the PathAI network to generate NASH consensus diagnoses. The AIM-NASH DDT is actively being pursued with the US Food and Drug Administration and European Medicines Agency in their respective Biomarker Qualification Programs.

“We are big believers in the transformative potential of PathAI’s AIM-NASH DDT to enable accurate and reproducible assessment of enrollment criteria and primary endpoints, in addition to increased sensitivity and statistical power for measuring response to treatment,” said Stephen Harrison MD, President of Summit Clinical Research. “This collaboration introduces a groundbreaking platform of drug development technologies and services to well-established and newly-founded programs alike."

Summit brings its track record of supporting many of the most active middle- and late-stage NASH drug development programs to the partnership. PathAI and Summit have already contracted with a sponsor to provide pathology services for a phase 2 clinical trial, with several additional trials under negotiation.

About PathAI

PathAI is a leading provider of AI-powered research tools and services for pathology. PathAI’s platform promises substantial improvements to the accuracy of diagnosis and the efficacy of treatment of diseases like cancer, leveraging modern approaches in machine and deep learning. Based in Boston, PathAI works with leading life sciences companies and researchers to advance precision medicine. To learn more, visit pathai.com.

About Summit

Summit Clinical Research is a leading Integrated Research Organization, with a focus on Non-Alcoholic Steatohepatitis (NASH) clinical trials. Through an innovative approach and the use of disruptive technologies, Summit delivers a full spectrum of study enrollment and site enrichment services to sites and scientific expertise to sponsors. With corporate offices in San Antonio, Texas, Summit brings together experienced clinical trial sites across the United States, in Europe and Latin America to execute clinical trials rapidly and with high quality data.