NKTT120 is a humanised monoclonal antibody that specifically depletes iNKT cells, a regulatory T cell that has been demonstrated as a major mediator of organ damage in preclinical models of sickle cell disease.
Previously, NKTT120 secured orphan drug status from the FDA for the treatment of sickle cell disease.
The company has also completed dosing in a Phase Ib trial of NKTT120 in patients with this disease and its primary goal is to determine the safety of the drug candidate in such patients.
Secondary endpoints of the trial include effects on markers of inflammation, daily pain scores, and quality of life.
NKT Therapeutics chief executive officer Robert Mashal said the company seeks to work with the FDA on the design of its efficacy trials for NKTT120.
"Fast Track status will help us reach our goal of bringing this new therapy to patients as rapidly as possible."
The company intends to advance into Phase IIb trials with endpoints showing clinical efficacy in 2015.