Investigational Sickle Cell Disease Agent Fast Tracked
NKT Therapeutics announced that the Food and Drug Administration (FDA) has granted Fast Track designation to NKTT120 for the treatment of sickle cell disease. NKTT120 is a humanized monoclonal antibody that specifically depletes iNKT cells.
The company has completed dosing in a Phase 1b trial of NKTT120 in patients with sickle cell disease. The primary goal of the trial is to determine the safety of NKTT120 in such patients. Secondary endpoints include effects on markers of inflammation, daily pain scores, and Quality of Life.
Previously, the FDA had granted Orphan Drug designation to NKTT120 for the treatment of sickle cell disease.
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