Pharma Focus Europe

CN Bio's PhysioMimix Organ-on-a-Chip Data Backs Inipharm’s INI-822 in Clinical Trials for Treating Metabolic Liver Disease

Tuesday, December 05, 2023

CN Bio, a prominent Organ-on-a-Chip (OOC) company specializing in the development of microphysiological systems (MPS) for single and multiple organs, has announced the significance of its PhysioMimix® assay for Non-alcoholic steatohepatitis (NASH) in confirming the efficacy of INI-822, a drug developed by Inipharm. Inipharm is a biopharmaceutical company focused on discovering and developing therapies for severe liver diseases. The use of CN Bio's in vitro OOC for early evidence of efficacy for INI-822 underscores the transformative potential of these models to provide human-relevant data in preclinical programs.

Inipharm has initiated Phase 1 dosing of its lead candidate, INI-822, a small-molecule inhibitor targeting HSD17B13, a gene implicated in NASH. Loss-of-function variants of this gene are associated with a reduced incidence risk and severity of multiple liver diseases. CN Bio's PhysioMimix OOC Systems and NASH 'in-a-box' (NIAB) kit were crucial in generating essential data to assess compound efficacy as part of the recent regulatory submission.

Despite extensive research efforts, there are currently no regulatory-approved therapeutics for NASH, primarily due to the limitations of traditional in vivo approaches in accurately predicting the human response to this complex metabolic disease. CN Bio's 'in-a-box' range, in conjunction with the PhysioMimix OOC, aims to streamline the incorporation of MPS into drug discovery workflows by offering a straightforward and rapid method to recreate industry-proven models and assays. The NIAB kit, specifically designed for NASH therapeutics, provides physiologically relevant insights into the disease mechanism, human drug efficacy, and potential treatment regimens. This assay addresses the human-relevance limitations of existing approaches, bridging the gap between human 2D cell culture and costly, ineffective animal models that fail to mimic the full disease spectrum.

Dr. Tomasz Kostrzewski, Chief Scientific Officer, expressed enthusiasm about Inipharm's progression to clinic, highlighting the immense potential for patients globally. He emphasized the role of the PhysioMimix system in providing physiologically relevant data supporting the regulatory submission, making CN Bio the first OOC provider whose data supports a drug entering clinical trials for a widespread metabolic, fibrotic liver disease. Dr. Kostrzewski underlined the historical constraints in developing NASH treatments and how OOC technology, as demonstrated by Inipharm's recent submission, offers a clear solution by enabling therapeutic developers to mitigate risks and avoid potential cross-species differences.

CN Bio's predictive, human, in vitro NASH model is accessible to customers through the company's Contract Research Services or the off-the-shelf NIAB kit, allowing users to integrate the PhysioMimix NASH model into their own workflows.



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