In a significant stride towards Alzheimer's disease (AD) treatment, Oscotec Inc. in collaboration with ADEL Inc., has announced the initiation of first-in-human dosing in the Phase 1 trial of ADEL-Y01, an innovative immunotherapy targeting the tau protein, a hallmark of AD pathology. This pioneering study marks the first administration of ADEL-Y01 to a healthy volunteer, setting the stage for a comprehensive evaluation of its potential as a disease-modifying treatment for AD.

ADEL-Y01 is engineered to specifically target the acetylated lysine-280 (acK280) of the tau protein, aiming to prevent its aggregation and the subsequent spread of toxic tau species within the brain. By halting these processes, ADEL-Y01 aspires to slow or even arrest the progression of Alzheimer's disease, offering hope to millions affected by this devastating condition.

The Phase 1a/1b trial, conducted in the United States, seeks to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ADEL-Y01 across a cohort of 40 healthy volunteers and 33 participants diagnosed with Mild Cognitive Impairment (MCI) due to Alzheimer's disease or those with mild Alzheimer's disease. This carefully designed study reflects the growing consensus in the scientific community regarding the critical role of tau in AD progression and the potential of tau-targeted therapies to provide clinical benefit.

"Targeting tau, particularly at the MTBR region, represents a promising therapeutic strategy given its strong correlation with the clinical severity and progression of Alzheimer's disease," stated SeungYong Yoon, MD/PhD, CEO of ADEL. "The initiation of this trial is a pivotal moment in our quest to develop effective treatments for neurodegenerative diseases."

Oscotec's CEO, Taeyoung Yoon, also expressed enthusiasm about the collaboration's milestone, highlighting the commitment to advancing the field of neurodegenerative disease treatment through innovative research.

The decision to advance ADEL-Y01 into human trials is supported by compelling preclinical evidence demonstrating its ability to mitigate memory impairment and behavioral deficits in animal models by inhibiting tau seeding and propagation. With the initiation of this first-in-human study, Oscotec and ADEL are at the forefront of developing potentially transformative treatments for Alzheimer's disease, offering new hope in the fight against this challenging condition.