GRI Bio is a drug development company focused on treating inflammatory diseases. We have a proprietary technology platform based on research out of University of California at San Diego that includes a portfolio of small molecule drugs and phospholipids that have demonstrated the ability to inhibit inflammatory immune responses by modulating type I and type II NKT cells. Our therapeutic areas of focus are liver disease and auto-immunity. Our lead candidate, GRI-0621, is an antagonist of type I NKT cells. It is currently in a phase IIa trial that should complete in summer of 2016. The endpoints of that study are improvements in liver biomarkers including ALT and AST. We are preparing a phase IIb study that will begin enrolling later this year that will have fibrosis as an endpoint and should complete in Q4 2017. In-vivo studies of GRI-0621 have demonstrated efficacy in models of NASH, ASH, fibrosis and autoimmune hepatitis. By virtue of its mechanism, the drug should also have efficacy against of a number of orphan liver conditions including PSC and biliary atresia.
Our second compound, GRI-0124, is an agonist of type II NKT cells. It is phase II ready and the target indication will likely be MS. We have a library of over 1000 NCE compounds with similar MOA. Two of these candidates are phase I ready.