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FDA grants fast track designation to NKTT120 for sickle cell disease
The FDA granted fast track designation to NKTT120 as a potential treatment for patients with sickle cell disease, the drug’s manufacturer announced.
NKTT120 (NKT Therapeutics) is a humanized monoclonal antibody that specifically depletes invariant natural killer T cells, which have been demonstrated to be key mediators of organ damage in preclinical models of sickle cell disease.
“We look forward to working with the FDA on the design of our efficacy trials for NKTT120,” Robert Mashal, CEO of NKT Therapeutics, said in a company release. “Fast track status will help us reach our goal of bringing this new therapy to patients as rapidly as possible.”
The FDA based its decision on interim results from an ongoing phase 1 safety and dose escalation study of NKTT120 in adults with stable sickle cell disease.
NKT Therapeutics also announced that it has completed dosing in a phase 1b trial of NKTT120 in patients with sickle cell disease. The primary goal of the trial is to evaluate the safety of NKTT120 in these patients, with secondary endpoints including effects on markers of inflammation, daily pain scores and quality of life.