CN Bio, an organ on a chip (OOC) company that designs and manufactures single-and multi-organ microphysiological systems (MPS), has announced that its PhysioMimix assay for non-alcoholic steatohepatitis (NASH) has been used to support biopharmaceutical company Inipharm’s lead candidate through to Phase I clinical trials.
The system has been found to provide human relevant data within preclinical programmes using in vitro OOC for early evidence of efficacy for INI-822 - Inipharm's lead candidate.
Inipharm has initiated Phase 1 dosing of INI-822 - a small-molecule inhibitor for HSD17B13, a gene implicated in NASH. Loss of function variants of this gene are known to be associated with reduced incidence risk and severity of multiple liver diseases. As part of the recent regulatory submission, CN Bio’s Contract Research Services team used the company’s PhysioMimix OOC Systems and NASH ‘in-a-box' (NIAB) kit to generate critical data to determine compound efficacy.
Despite research efforts to combat the growing prevalence of NASH, there are currently no regulatory approved therapeutics due to the inability of traditional in vivo approaches to accurately predict the human response to this complex metabolic disease. In conjunction with the PhysioMimix OOC, CN Bio’s ‘in-a-box’ range aims to fast-track the incorporation of MPS into drug discovery workflows by providing a straightforward and quick route to recreating the company’s industry-proven models and assays.
The NIAB kit was launched to support the urgent development of NASH therapeutics, providing physiologically relevant insights into the mechanism of disease, human drug efficacy and potential treatment regimens. The assay addresses the human-relevance limitations of existing approaches, bridging the gap between human 2D cell culture and expensive animal models, which are ineffective in mimicking the full disease spectrum.
Dr Tomasz Kostrzewski, Chief Scientific Officer, said: “Inipharm’s progression to clinic is absolutely fantastic news and holds immense potential for patients worldwide. We are thrilled that our PhysioMimix system was able to provide physiologically relevant data to support the regulatory submission, becoming the first OOC provider whose data is supporting a drug to enter the clinic for a widespread metabolic, fibrotic liver disease.”