Alimentiv, AcelaBio, and PharmaNest Unite To Revolutionize Precision Medicine and AI Digital Pathology For NASH/MASH Clinical Trials.

LONDON, ON, Nov. 8, 2023 /PRNewswire/ — Alimentiv Inc., AcelaBio Inc., and PharmaNest Inc. are pleased to announce their collaborative effort aimed at revolutionizing precision medicine and artificial intelligence (AI)-enabled digital pathology solutions for metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH) clinical trials. This collaboration will enable clinical trial sponsors to quantify the histological effects of compounds and gain deeper insight into underlying mechanisms in MASH-targeted therapies using state-of-the-art spatial transcriptomics and AI-powered single-fiber and single-cell digital pathology. By harnessing the collective expertise of Alimentiv, AcelaBio, and PharmaNest, this collaboration will establish an integrated ecosystem that seamlessly combines high throughput specialty anatomic and molecular pathology, precision medicine technologies, bioinformatics, and AI-powered digital pathology image analysis. Integrating these cutting-edge solutions is a significant advancement in applying novel technologies to enable high-quality end-to-end tissue assays, allowing clinical trial sponsors to drive scientific discoveries and accelerate drug development in MASH, a disease with a growing impact and currently no approved therapies.

AcelaBio, a CAP/CLIA-certified clinical research laboratory known for its end-to-end digital pathology workflows, will carry out tissue sample analysis to generate whole slide images and molecular data. “Our collaboration holds great potential for the advancement of MASH clinical research to further the identification and quantification of digital pathology biomarker data and to enhance clinical development,” said Niels Vande Casteele, Ph.D., President of AcelaBio. “By creating seamless workflows integrating advanced sample analysis, digital pathology, bioinformatics, and AI-powered analysis, we can unlock new opportunities to identify biomarker signatures within the spatial context of the tissue.”

The collaborative efforts of Alimentiv, AcelaBio, and PharmaNest will facilitate the seamless integration of robust digital pathology operational workflows and Artificial Intelligence in MASH clinical trials, ultimately leading to the development of personalized therapies and improving patient outcomes.

“Alimentiv prioritizes leading with science through our commitment to developing innovative early clinical trial designs and outcome assessments. Our expertise in endpoint assessments and precision medicine analyses, including bioinformatics and AI-powered digital pathology biomarker quantitation, positions us along with our collaborative partners to innovate and transform the landscape of MASH clinical trials,” said Wendy Teft, Ph.D., VP of Precision Medicine at Alimentiv. “Through the integration of our respective technologies and expertise, we aim to empower clinical trial sponsors with the necessary tools to improve the quality of histological endpoints, uncover novel biomarkers, and accelerate drug development timelines by gaining comprehensive insights into the underlying mechanisms of action in MASH targeted therapies.”

PharmaNest, recognized for its excellence in MASH digital pathology and Artificial Intelligence analysis services, will play a pivotal role in this collaboration by providing high-resolution, single-fiber, and single-cell quantitative image analysis and AI-powered biomarkers from the same images reviewed by pathologists for critical endpoint assessments. Together, these organizations will enhance the quality of current histological endpoints required for the interim FDA approval of therapies in MASH and enable the analysis of complex data sets, leading to a comprehensive understanding of MASH pathology and the discovery of new biomarkers.

“Using our digital pathology FibroNest platform, the automated high-resolution quantification of the phenotype of fibrosis severity and related tissue injury from the same slides reviewed by pathologists offers a robust and scalable method to generate continuous scores that resolve faint changes in fibrosis severity and disease activity and can be used in MASH Trials to assist pathologists and enrich the quantification of the effect of an intervention. Our Fibrosis Digital Pathology biomarker, Ph-FCS, offers exceptional performance as a diagnostic tool for early and severe fibrosis. The recently published results showing that it can also predict liver-related events and outcomes opens the road for its future qualification as a likely surrogate endpoint in MASH studies,” says Mathieu Petitjean, Ph.D., CEO of PharmaNest. “The partnership with Alimentiv and AcelaBio will ensure sponsors receive a superb end-to-end digital pathology tissue assay where pre-analytical conditions are well controlled during the length of a study.

The collaboration between Alimentiv, AcelaBio, and PharmaNest represents a substantial leap forward in integrating precision medicine and digital pathology solutions for MASH clinical trials. By uniting their expertise, these organizations aim to further enhance early drug development efficiency to get safe and effective treatments to patients in a more expedient fashion.

Clinical trial sponsors interested in accessing the benefits of this service collaboration are encouraged to contact the respective organizations for further information.

About Alimentiv Inc.

Alimentiv is a global gastroenterology-focused contract research organization (CRO) providing clinical trials, central image management, precision medicine, and real-world evidence services to the pharmaceutical and biotechnology industries. Headquartered in London, Ontario, Alimentiv employs more than 500 people across its operations in Canada, the United States, Europe, Asia-Pacific, and Latin America. The organization’s unique model combines the efforts of internationally recognized academic researchers and operational experts to offer integrated solutions to customers. Over the past 20 years, Alimentiv has become a recognized expert in clinical trial design, central image management solutions, outcome measure development, and precision medicine for drug development in GI. Today, Alimentiv provides services in more than 50 countries worldwide, collaborates with leading universities and academic institutions across the globe, and works with many leading pharmaceutical and biotechnology organizations to bring new and improved treatment options to patients. Alimentiv is committed to investment in medical research and development, focusing on identifying barriers to drug development and pursuing solutions that advance GI research. The research findings are operationalized into an efficient clinical trial methodology for clients that aligns with emerging regulatory standards. In collaboration with leading experts, Alimentiv has pioneered the development, validation, and standardization of outcome measures and technology, shaping the evolving clinical trial landscape for multiple indications and providing meaningful long-term consequences for patients, their treatment, and society. For more information, visit: www.alimentiv.com

About AcelaBio (US) Inc.

AcelaBio is a state-of-the-art, CAP/CLIA-accredited, contract research organization delivering end-to-end histopathology and precision medicine services for pharmaceutical, biotech, and academic institutions. AcelaBio provides high-throughput digital pathology services to support multicenter, global clinical trials and has the flexibility to develop and validate biomarker assays for novel or existing protein or molecular targets. For discovering novel biomarker signatures and interrogating the spatial biology of tissues, AcelaBio implemented 10X Genomics Visium Spatial Transcriptomics into its workflows. AcelaBio’s laboratory capabilities are applicable across a wide range of therapeutic indications, including gastroenterology, oncology, and dermatology. AcelaBio is highly specialized in testing gastrointestinal tissues from patients with inflammatory bowel diseases (e.g., Crohn’s disease and ulcerative colitis), eosinophilic gastrointestinal diseases (e.g., eosinophilic esophagitis), and liver diseases (metabolic dysfunction-associated steatohepatitis). AcelaBio employs operational, scientific, and medical experts, including U.S. board-certified pathologists, who are dedicated to delivering reliable, high-quality data and imagery. For more information, visit: www.acelabio.com

About PharmaNest

PharmaNest is a Digital Pathology and Artificial Intelligence company focused on the development and validation of novel histological standards for the quantification of Inflammation and fibrosis. Its multivendor platform, FibroNest, is delivered worldwide via the cloud and used in multiple pre-clinical and clinical studies across several fibrotic conditions, including MASH, PBC, PSC, IBD, EoE, Sjogren’s, Fibro-Immuno-oncology and more.

For more information about FibroNest and PharmaNest, visit www.pharmanest.com and www.fibronest.com

Fern Livingstone, Tel: 519.639.3205, Email: fern.livingstone@alimentiv.com