There have been many bilateral discussions with pharmaceutical companies leading up to this study.
Key issues which both sides are contributing to equally include trial design, trigger criteria for phase III, co-development of biomarker measurement, licensing requirements, and technical expertise.
The collaborative work with GSK aimed to identify the effect of small molecules that inhibit the binding of Bromodomain (BRD) and Extra-Terminal (BET) family to histones in peripheral blood mononuclear cells from patients with inflammatory liver indications. The potential for expanding BET inhibitors (iBET) into alcoholic hepatitis and related inflammatory hepatic indications where monocyte-macrophage dysregulation is a driver of pathology was assessed by evaluating mainly the effect of iBET on monocyte phenotype and function.
Novartis have agreed to support the consortium by funding a clinical trial of cannakinumab (ISAIAH trial) which will allow us to test the the impact of interleukin 1b inhibitor on liver histology, portal pressure and liver function.