Sekisui XenoTech has added additional hepatotoxicity screening assays and methodologies to the company’s existing cytotoxicity contract research services. Cytotoxicity studies assess the risk that test articles may cause toxicity in cells, with hepatotoxicity specifically related to the liver.

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, not to mention potentially saving patient lives.

“Early discovery of hepatotoxicity is essential to screening new drug candidates, but poses many inherent challenges,” said David Buckley, Ph.D., Sekisui XenoTech’s chief scientific officer. Drug induced liver injury (DILI) or hepatotoxicity is one of the leading causes of adverse events during clinical trials, which often results in failures or clinical holds during the development of new drug candidates, and even withdrawals from the market. DILI observed in a clinical setting is often idiosyncratic with undefined mechanism(s) of toxicity and low incidence rates, even in large populations due to the increased number of drugs in medical care and the increased number of patients. However, 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.

Dr. Buckley continued, “Sekisui XenoTech has provided in vitro cytotoxicity screening services for many years, often as part of enzyme induction studies. However, considering the prevalence of DILI during clinical trials, we have increased our focus on hepatotoxicity to protect our customers from costly drug candidate failures further down the development pipeline.”

“It 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,” explained Becky Campbell, Sekisui XenoTech’s principle scientist for Toxicology Research Services.

Sekisui XenoTech is a global CRO with experience and expertise from discovery through clinical support, providing cell and tissue-based products, screening, radiolabeling, API manufacturing, in vitro ADMET and pharmacology, in vivo ADMET and QWBA, metabolite ID and production, bioanalytical services and consulting.