Inipharm has initiated Phase I dosing of its lead candidate, INI-822, which is a small-molecule inhibitor for HSD17B13, a gene implicated in nonalcoholic steatohepatitis (NASH).
Loss-of-function variants of HSD17B13 are known to be associated with reduced incidence risk and severity of multiple liver diseases.
CN Bio’s PhysioMimix Organ-on-a-Chip (OOC) Systems and NASH ‘in-a-box’ (NIAB) kit was used to provide human-relevant data on compound efficacy for INI-822. This is the first example of an OOC provider’s data supporting clinical progression of a drug for metabolic, fibrotic liver disease.
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.
Dr Tomasz Kostrzewski, Chief Scientific Officer, CN Bio, 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.”
He added: “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.”