Sekisui XenoTech announced it has added supplementary hepatotoxicity screening assays and methodologies to its existing cytotoxicity contract research services.
According to the company, Hepatotoxicity, or drug induced liver injury (DILI) is one of the leading causes of adverse events during clinical trials and can lead to drug failures, clinical holds, or market withdrawals.
Matt Beck, Sekisui XenoTech’s Global Marketing Manager, told us the company has provided in vitro cytotoxicity screening services for many years, often as part of enzyme induction studies. However, the company is increasing its focus on hepatotoxicity in order to protect its customer from costly drug candidate failures further down the development pipeline.
As Beck explained, "Discovering risks of liver injury during the preclinical stage of development, instead of clinical trials, can save hundreds of millions of dollars or more, and years of fruitless research.”
Becky Campbell, Sekisui XenoTech’s Principle Scientist for Toxicology Research Services, told Outsourcing-Pharma.com, “[This is] not to mention potentially saving patient lives by discovering the potential for DILI early in development.”.
However, early discovery of hepatotoxicity is challenging.
“DILI observed in a clinical setting is often idiosyncratic with undefined mechanisms of toxicity and low incidence rates, even in large populationsdue to the increased number of drugs in medical care and the increased number of patients,” said Campbell.
Yet, she explained that several mechanisms contributing to DILI have been well-characterized and have the potential to be tested in a non-clinical setting or with in vitro tools.
Campbell added that the addition of supplementary offerings “is a natural progression to add tools to our in vitro hepatocyte services that complement and expand our expertise.
“Our goal is to work with our clients’ project teams to design and guide an intelligent approach to the evaluation of hepatotoxicity with knowledge of mechanisms, in vitro tools and the application of various endpoints, combined to provide data suitable for decision making, whether during early-stage discovery or late-stage development,” she said.