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INSIGHTS

The industry restores confidence in NASH new drug R&D with Madrigal Pharmaceuticals’ submission of a rolling review for Resmetirom in this July and the rise of GLP-1 receptor agonists treatments for NAFLD/NASH, e.g., Semaglutide for NASH at Phase III from Novo Nordisk; Tirzepatide for NASH at Phase II from Eli Lilly; Efinopegdutide for NAFLD at Phase 2a from MSD, etc.

With focus on studying immunology, inflammation and metabolic disease models for more than 15 years, John Liu, Head of Pharmacology, BioDuro-Sundia shares his insights on the industry challenges and how a highly clinically translatable NASH model can help.


Complimentary Download: A New Obesogenic NASH Mouse Model. In this exclusive 13-page NASH Guide you will learn about:

• Prevalence and Progression of NASH

• Multifactorial NASH Pathogenesis – Challenges to Develop Effective Treatments & Animal Models

• Types of Animal Models for NAFLD/NASH

• A New NASH Model Induced with Modified HFD Plus Fructose

• Liver Lesion and Dyslipidemia Manifested in the New NASH Model

• Validation of the New NASH Model with Reference Drugs

• And more…

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Why is NASH new drug research and development so hard? What are the technical difficulties and industry pain points of this area at present?

Due to the complex pathogenetic mechanism and considerable heterogeneity of NASH, multiple phase II/III NASH studies failed with monotherapy. A few candidate drugs show good efficacy but with low patient response rate.

Histological evaluation based on liver biopsy is of great value but needs to be improved due to potential risk of invasive injury, sampling variability, insufficient evaluation of dynamic changes in fibrosis and inadequate identification of the complex heterogeneity.

Reliable preclinical evaluation of compounds in animal NASH models with high clinical translatability is of tremendous value to accelerate the development of effective NASH treatments.

What can NASH models at BioDuro-Sundia help new drug discovery?

Our novel NASH model exhibits hallmarks of NASH and the modified High Fat Diet plus Fructose induces hepato-steatosis and fibrosis with increased insulin, glucose, cholesterol, triglyceride and free fatty acid. With respect to histopathological results, the liver has increased steatosis, lobular inflammation, ballooning, Mallory body and robust fibrosis. The phenotype is consistent to human metabolic syndrome/Nash-Fibrosis.

Our NASH model has also shown superior clinical translatability. We have evaluated GFT505, Semaglutide, OCA and Resmetirom in this model to assess the correlation of readouts from our NASH model with the clinical trial outcomes of these compounds. These four reference drugs are chosen because they act on 4 different classes of prominent therapeutic targets for NASH, respectively. The data of these four reference drugs derived from BioDuro-Sundia’s NASH model is fully consistent with the results from their clinical trial studies.

What are the highlights of the studies on NASH and other Metabolic Diseases models at BioDuro-Sundia?

BioDuro-Sundia has established a novel NAFLD/NASH model, which mimics the pathogenesis of clinical NASH patients and exhibits hallmarks of NASH, including steatosis, lobular inflammation, ballooning and fibrosis in 12 - 16 weeks of dieting with total experiment duration almost half of other HFD induced NASH models, saving valuable time and cost for the preclinical study of NASH. BioDuro-Sundia now are keeping mice on our NASH diet so clients don’t need to wait for model induction and can start treatment once the compounds are ready.

With more than 15 years’ experiences in immunology, inflammation and metabolic disease models, we have a deep understanding of the disease mechanisms and different targets and we are committed to providing novel and high-quality solutions to our partners of new drug discovery.

Large Molecule Bioanalysis Services
BioDuro-Sundia’s large molecule bioanalysis DMPK/ADME platform provides representative research services to a variety of molecular modalities including mAbs, ADC, oligonucleotides, large or small molecule biomarkers or metabolites, proteins and peptides.
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