Oscotec Inc. and ADEL Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application of ADEL-Y01 for the treatment of Alzheimer's disease (AD). Oscotec and ADEL are jointly developing a novel disease-modifying immunotherapy agent (ADEL-Y01) targeting tau protein accumulation in the AD brain. ADEL-Y01 is a recombinant IgG1 class type monoclonal humanized antibody that recognizes and binds to tau protein acetylated at lysine-280 (acK280) thus inhibiting aggregation and propagation of tau seeds and enhancing microglial tau clearance.

Administration of ADEL-Y01 has ameliorated memory impairment, behavioral deficits, and tau pathology in preclinical models, which was published early this year ("Monoclonal antibody Y01 prevents tauopathy progression induced by lysine 280-acetylated tau in cell and mouse models" in The Journal of Clinical Investigation) This phase 1a/1b study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ADEL-Y01 in healthy volunteers as well as in participants with Mild Cognitive Impairment due to Alzheimer's disease or mild Alzheimer's disease.