Oscotec (Seognam, South Korea) and ADEL (Seoul, South Korea) announced that their investigational new drug (IND) application for ADEL-Y01, a novel IgG1 class type monoclonal humanized antibody that binds to tau protein acetylated at lysine-280, was cleared by the Food and Drug Administration (FDA). Oscotec and ADEL are jointly developing ADEL-Y01, which has been shown in previous studies to prevent tauopathy progression by reducing the aggregation and propagation of tau and assisting in its clearance by microglia. The safety, tolerability, and pharmacokinetics of ADEL-Y01 will be assessed in a phase 1a/1b study which will include both healthy volunteers and participants with early Alzheimer disease (AD).

Results of a preclinical study, published in The Journal of Clinical Investigation, demonstrated that ADEL-Y01 inhibited in vivo seeding and propagation of tau proteins acetylated at K280 (tau-acK280). Tau acetylation is known to increase tau aggregation and decrease tau degradation, playing a pathogenic role in neurodegenerative conditions including AD. In the study of ADEL-Y01, acetylation at K280 was shown to cause tau secretion, potentially initiating states of tau pathology. The researchers also administered ADEL-Y01 to mice with tau-acK280­, and the animals subsequently showed improvements in cognition and motor performance. These results highlight the need for clinical studies to evaluate ADEL-Y01’s potential as a therapy for AD.

"We are convinced that ADEL-Y01 has the strong potential to be a much needed treatment option for patients with Alzheimer's disease based on its novel mechanism of action and the strength of preclinical data," said Dr. Taeyoung Yoon, CEO/CSO of Oscotec.