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Oscotec and ADEL Receive FDA Clearance for ADEL-Y01

Friday, September 15, 2023

Oscotec and ADEL have jointly received clearance from the U.S. Food and Drug Administration (FDA) to proceed with their investigational new drug (IND) application for ADEL-Y01, which is intended for the treatment of Alzheimer's disease (AD).

The two companies will collaborate for the development of ADEL-Y01, an innovative immunotherapy agent designed to modify the course of the disease. ADEL-Y01 is a humanised monoclonal antibody of the IgG1 class, engineered to specifically target tau protein accumulation in the brains of individuals with AD.

It accomplishes this by binding to tau protein that has been acetylated at lysine-280 (acK280), thereby preventing the aggregation and spread of tau seeds, while also enhancing the clearance of tau by microglial cells.

Preclinical studies have demonstrated that the administration of ADEL-Y01 results in significant improvements in memory function, behavioural deficits, and reduction in tau pathology in animal models. With its unique mechanism of action, ADEL-Y01 holds great promise as a much-needed treatment option for individuals suffering from Alzheimer's disease.

The phase 1a/1b study for ADEL-Y01 will focus on assessing its safety, tolerability, pharmacokinetics (how the drug is processed in the body), and clinical efficacy. This study will involve both healthy volunteers and participants diagnosed with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease.

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