NI009

NI009 is a preclinical human monoclonal antibody being developed by Neurimmune in collaboration with Alexion (AstraZeneca Rare Disease) for the treatment of light chain (AL) amyloidosis. The drug is designed to target and deplete lambda light chain fibrils and deposits from affected tissues and organs. NI009 functions as a fibril depleter that triggers immune-mediated clearance of disease-causing protein aggregates. The antibody exhibits broad activity against amyloids of diverse lambda light chain subtypes across patients despite the high clonal heterogeneity of the disease. In December 2025, Neurimmune entered into an exclusive global collaboration and license agreement with Alexion, granting Alexion worldwide rights to research, develop, manufacture, and commercialize NI009. Neurimmune remains responsible for preclinical development, initial manufacturing, and conducting the first-in-human clinical study, while Alexion will handle further clinical development and commercialization.