NKGen Biotech (NKGN) announced that the U.S. Food and Drug Administration, FDA, has granted Expanded Access Program, EAP, authorization for its IND for an open-label, non-randomized, multi-center intermediate size expanded access protocol for use of troculeucel for neurodegenerative diseases. This includes its use for the treatment of several neurodegenerative diseases, many of which currently have no effective therapy. While NKGen’s ongoing double-blind randomized Phase 2a trial is focused on moderate-stage Alzheimer’s disease, this EAP IND marks the company’s exploration into the treatment of other less common neurodegenerative diseases. In addition to earlier stage Alzheimer’s Disease, this IND includes the treatment of Parkinson’s Disease, Amyotrophic Lateral Sclerosis, Multiple System Atrophy, Progressive Supranuclear Palsy, Frontotemporal Dementia, Corticobasal degeneration, Multiple Sclerosis and Lewy Body Dementia.
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