CN Bio advances hepatotoxicity testing to reduce drug failures

CN Bio, a leader in organ-on-a-chip (OOC) systems for drug discovery, has launched the PhysioMimix^® DILI assay kit: Human 24. This new kit aims to improve preclinical toxicology testing by offering more human-relevant insights into drug-induced liver injury (DILI).

Built upon CN Bio’s human-derived and highly characterised liver microphysiological system (MPS), the DILI assay kit provides robust insights into crucial drug safety parameters. This allows for more informed clinical progression of drug candidates, enhanced clinical preparedness, and helps de-risk drug development workflows by ensuring only the most promising therapeutic candidates are selected.

Addressing a critical need in drug development

The company emphasises the high rate of drug candidate failure in clinical trials, with 30 percent of candidates failing, 18 percent of which are due to hepatotoxicity – liver damage caused by toxic substances like drugs, chemicals, or alcohol.

Current preclinical approaches, which utilise a combination of in vitro assays, in vivo animal studies, and in silico modelling, are often limited by sensitivity, clinical translatability, and physiological relevance. CN Bio’s FDA-recognised liver MPS aims to overcome these limitations by providing robust, human-specific data to accurately inform drug-induced hepatotoxicity.

Initially offered as part of the company’s contract research services (CRS), the human DILI assay has now been refined into an all-in-one kit. This streamlines workflows by removing the complexities associated with MPS model development and validation, enabling new users to rapidly integrate the OOC solution into their own labs. The kit is designed to optimise preclinical drug development by providing deeper, physiologically relevant, mechanistic hepatotoxicity insights.

CN Bio’s liver model recreates highly functional and metabolically active hepatic tissues. It can be maintained under perfusion for up to two weeks and incorporates Kupffer cells to capture crucial aspects of the human innate immune system. This facilitates deeper insights into complex toxicology events over extended timeframes. By leveraging primary human tissue, the kit better supports the development of new, human-specific drug modalities, an area where traditional preclinical tools often lack the relevant targets or pathways.

Each DILI assay kit contains 24 wells, allowing users to simultaneously assess up to eight conditions in triplicate. This breadth of data output, covering key DILI pathways, enables customers to easily screen a selection of drug candidates. 

Expert insight

Dr Ovidiu Novac, Senior Scientist and Project Manager (DILI assay kit), CN Bio, said: “Toxicology testing is perhaps the most essential part of developing a new drug, but our current preclinical methods often fall short, putting therapeutic developers at risk of extremely costly, late-stage failures. Previously available via our CRS, we chose to further develop our DILI assay into a simple, all-in-one kit, in response to increasing demand for human-relevant, preclinical toxicology testing. With Human 24, PhysioMimix users can now more easily replicate our industry-leading DILI assay in their own lab, providing deeper mechanistic insights into drug-induced hepatoxicity and enabling more confident progression of drug candidates into the clinic.”

The launch of the PhysioMimix DILI assay kit: Human 24 represents a significant advancement in preclinical toxicology. By providing a more human-relevant, efficient, and accessible approach to DILI assessment, CN Bio is helping researchers make more informed decisions, ultimately accelerating the development of safer and more effective therapies.

This innovative technology has the potential to significantly reduce the rate of costly late-stage drug failures, bringing new hope to patients and transforming the future of drug development.