Oscotec Inc, a clinical stage drug discovery and development company, and ADEL Inc., a Korea-based biotech company, announced on Thursday that they have received approval from the US Food and Drug Administration (FDA) for the investigational new drug (IND) application of ADEL-Y01 intended for treating Alzheimer's disease (AD).

Both companies are jointly developing a novel disease-modifying immunotherapy agent (ADEL-Y01) aimed at tau protein accumulation in the AD brain. The product is a recombinant IgG1 class type monoclonal humanised antibody that recognises and binds to tau protein acetylated at lysine-280 (acK280), stopping aggregation and propagation of tau seeds and improving microglial tau clearance.

A phase 1a/1b study is being conduction to assess the safety, tolerability, pharmacokinetics, and clinical activity of the product in healthy volunteers and in participants with Mild Cognitive Impairment due to Alzheimer's disease or mild Alzheimer's disease.

Dr Taeyoung Yoon, CEO/CSO of Oscotec, said, '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. Initiating the first-in-human study of ADEL-Y01 is a significant milestone to the Oscotec-Adel partnership, which also serves as a vehicle for Oscotec in expanding its R&D horizon beyond small molecule.'