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Phase II (ready) Phospholipid to Treat MS and Other Autoimmunities
GRI Bio, Inc United States flag United States
Abstract ID:
Phospholipid type II NKT agonist to treat MS and other autoimmune conditions. Ready for phase II. Excellent data in in-vivo models of MS
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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.

GRI-0124 is an orally delivered phospholipid that has an established safety profile. The ability of the drug to stimulate type II NKT cells has shown significant reductions in autoimmune inflammatory responses. The drug has all required safety data to begin a phase II trial. In-vivo models of MS have shown impressive improvements in the disease.

We have a library of over 1000 NCE compounds with similar MOA. Two of these candidates are phase I ready and could be targeted for MS or other autoimmune conditions such as IBD, Chron's disease or rheumatoid arthritis.
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
FEATURED
Last Updated Feb 2017
Technology Type THERAPEUTIC
Phase of Development CLINICAL TRIALS
CORPORATION

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