CN Bio PhysioMimix® Organ-on-a-Chip data supports Inipharm’s INI-822 for metabolic liver disease treatment now in clinical testing.

  • PhysioMimix NASH assay used to provide human-relevant data on compound efficacy for Inipharm’s lead candidate, INI-822
  • Submission represents first example of an OOC provider’s data supporting clinical progression of a drug for metabolic, fibrotic liver disease

CN Bio, a leading Organ-on-a-Chip (OOC) company that designs and manufactures single-and multi-organ microphysiological systems (MPS), today announced its PhysioMimix assay for non-alcoholic steatohepatitis (NASH) was important for confirmation of efficacy for INI-822 from Inipharm, a biopharmaceutical company focused on discovering and developing therapies for severe liver diseases. The use of in vitro OOC for early evidence of efficacy for INI-822 demonstrates the transformative potential of these models to provide human-relevant data within preclinical programmes.

Inipharm has initiated Phase 1 dosing of its lead candidate1, INI-822. INI-822 is 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 utilised 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.”

“Despite its prevalence, development of NASH treatments has been constrained for a long time due to a lack of clinical translatability during preclinical research. Inipharm’s recent submission has shown that OOC technology provides a clear route to overcoming this problem by enabling therapeutic developers to de-risk and avoid potential cross-species differences.”

CN Bio’s predictive, human, in vitro NASH model is available to customers via the Company’s Contract Research Services, or via the off-the-shelf NIAB kit, enabling users to incorporate the PhysioMimix NASH model into their own workflows.

For more information about INI-822 visit: Inipharm’s press release