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Phase II Drug for Liver Disease (NASH)
GRI Bio, Inc United States flag United States
Abstract ID:
GRI-0621 is a small molecule drug that targets type I NKT cells to inhibit inflammatory diseases including chronic liver disease and various autoimmune conditions including MS, IBD and RA.
Contact Sean Edwards
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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.
Clinical Trial Information (1) Hide
Change in serum ALT levels from Day 0 (baseline) to Day 28|Change in serum AST levels from Day 0 (baseline) to Day 28|Response to 4.5mg GRI-0621 versus 6mg GRI-0621 in terms of the change in serum ALT levels from Day 0 (baseline) measured at the different trial time points.|Changes in serum cytokeratin 18 (CK-18) levels from Day 0 (baseline) to Day 28,|NKT cell activity measured by multi-color flow cytometry at Day 0 (baseline) and at Day 28 following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo.|Measurement of GRI-0621 peak plasma concentration [Cmax] on Day 7 and Day 28.|Measurement of GRI-0621 time to reach Cmax [Tmax].|Measurement of GRI-0621 half life [t1/2]|Measurement of GRI-0621 clearance [CL] on Days 7 and 28|Measurement of GRI-0621 volume of distribution [Vd] on Days 7 and 28
CONDITIONS
Chronic Liver Disease
INTERVENTIONS
Drug: Placebo Comparator|Drug: Active Comparator:4.5mg GRI-0621|Drug: Active Comparator: 6.0mg GRI-0621
NCT02949375
PHASE 2
RECRUITING
Last Verified First Received Last Updated Estimated Completion
2016-10-01 2016-10-26 2016-10-27 2017-09-17
Type of Business Relationship Sought
Licensing or co-development agreement with particular interest in APAC region, MENA region and Russia.
FEATURED
Last Updated Feb 2017
Technology Type THERAPEUTIC
Phase of Development PHASE 2
CORPORATION

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