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May 2020

New Preclinical Models for NASH Provide Strong Clinical Relevance and Shortened Timelines

-- Mouse and Hamster Models develop fatty liver disease and NASH in 2-3 months --

SAN DIEGO, May 26, 2020 — BioDuro, LLC, a leading drug discovery and development services organization, announced today the availability of two new preclinical models for Non-alcoholic
steatohepatitis (NASH) that highly resemble clinical progression of the disease and do so in a matter of 2-3 months. The models include mouse and hamster species, and manifest all the hallmarks of NASH disease, enabling drug developers to evaluate broad classes of drug targets, including metabolic inflammation and fibrogenic pathways alike.

NASH is a severe form of non-alcoholic fatty liver disease (NAFLD), and is expected to be the leading cause of liver failure and transplant in the next five years. Despite the high prevalence, there is no FDA approved therapy. Accordingly, biopharma companies are heavily targeting NASH; however, progress has been limited by preclinical models that do not accurately mimic NASH disease complexity or take extremely long to develop the disease, making them impractical for preclinical timelines.

“The new NASH models we have developed represent considerable progress for NASH drug development by providing clinically-translatable biological test systems that can be performed in pragmatic timelines,” said Xiang Li, DPhil, Senior Vice President, Integrated Biology at BioDuro. “These mouse and hamster models add to our current NASH panel, providing a full spectrum of NASH disease models for our biopharma partners to help address their different needs.”

BioDuro’s new mouse NASH model is induced by feeding mice a standard high fat diet (HFD), followed by a modified high fat diet (mHFD). The initial model induction before compound treatment is 16 weeks and can be as short as 12 weeks, compared to 24 weeks for other mouse models relying on HFD approaches.

BioDuro’s new hamster NASH model is based on feeding hamsters a high fat, high cholesterol and high sugar diet (HFC+F). Compared to other models, the hamster HFC+F model has an even shorter induction period of 8-12 weeks, and higher fibrosis score. Another notable advantage of the hamster model is that hamster lipid metabolism is more similar to that of humans, making it a suitable model system for a number of drug targets that are otherwise absent in mouse models.

For both the mouse and hamster NASH models, histology and biomarkers show clinically relevant levels of disease phenotype and scores, including: steatosis, hepatocyte ballooning, inflammation, and fibrosis. Metabolic profiles have similarly altered obesity markers as human NASH, including: insulin, glucose, cholesterol, triglycerides and free fatty acid.

In addition to the new models that BioDuro has launched, the company has 3 other NASH models to meet the needs and preferences of clients. The additional NASH models offered by BioDuro include: disease induction based on western diet (AMLN), chemical induction (AMLN+CCL4), and nutrient deficiencies (MCD).

About BioDuro
BioDuro, an Advent International portfolio company, is a leading global life sciences research and development organization that provides biopharmaceutical clients and partners with comprehensive, fully integrated drug discovery and development services, from lead development and IND-enabling studies to GMP manufacture of drug product for clinical trials. Core expertise includes small and large molecule discovery, development and scale up, combined with unique technology platforms such as bioavailability enhancement of insoluble compounds. The company has 4 global sites: headquarters in San Diego, California and 3 major operations in Beijing, Shanghai and Jiangsu, China. BioDuro’s integrated China and US teams afford partners with the benefits of a truly global and seamless operation, significantly accelerating discovery and de-risking development to create higher value outcomes.

For more information, visit:
www.bioduro.com
www.linkedin.com/company/bioduro

About Advent International
Founded in 1984, Advent International is one of the largest and most experienced global private equity investors. The firm has invested in over 350 private equity transactions in 41 countries, and as of September 30, 2019, had $56.6 billion in assets under management. With 15 offices in 12 countries, Advent has established a globally integrated team of over 200 investment professionals across North America, Europe, Latin America and Asia. The firm focuses on investments in five core sectors, including business and financial services; health care; industrial; retail, consumer and leisure; and technology. After 35 years dedicated to international investing, Advent remains committed to partnering with management teams to deliver sustained revenue and earnings growth for its portfolio companies.

For more information, visit:
www.adventinternational.com
www.linkedin.com/company/advent-international

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