ADEL-Y01 / Oscotec, ADEL - LARVOL DELTA

A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01 (clinicaltrials.gov) - P1 | N=73 | Recruiting | Sponsor: Alzheimer's Disease Expert Lab (ADEL), Inc. | Trial completion date: Feb 2026 ➔ Jul 2027 | Trial primary completion date: Oct 2025 ➔ Jun 2027

First-in-human • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

"Oscotec Expects Technology Transfer of Alzheimer's New Drug 'ADEL-Y01'" [Google translation] (Newspim) - "Eugene Investment & Securities maintained its investment opinion of buy and target stock price of 53,000 won for KOSDAQ-listed company Oscotec on the 11th, saying....it forecasted that a re-rating of corporate value would be possible upon technology transfer following the completion of the global phase 1 clinical trial of ADEL-Y01, which is being jointly developed with Adele."

Commercial • Alzheimer's Disease

IMMUNOTHERAPEUTIC TARGETING LYSINE280 -ACETYLATED TAU FOR ALZHEIMER'S DISEASE WITH ADEL-Y01 (ADPD 2025) - "Our results demonstrate that acetylated lysine280 tau is a core species involved in tau aggregation and propagation. Among the numerous propose d epitopes of tau, acetylated lysine280 presents a promising target for the treatment of tauopathies. ADEL -Y01 is currently undergoing phase Ia/Ib clinical trial in the United States in collaboration between ADEL and Oscotec."

Alzheimer's Disease • CNS Disorders

Drug Development. (PubMed, Alzheimers Dement) - "Based on our observations that tau-acK280 is a core species involved in seeding and propagation activities, the Y01 antibody that specifically recognizes acK280 represents a promising therapeutic candidate for AD and other neurodegenerative diseases associated with tauopathy. ADEL-Y01 is currently undergoing a phase-1 clinical trial in the United States through a collaborative effort between ADEL and Oscotec."

Journal • Alzheimer's Disease • CNS Disorders

A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01 (clinicaltrials.gov) - P1 | N=73 | Recruiting | Sponsor: Alzheimer's Disease Expert Lab (ADEL), Inc. | Trial completion date: May 2026 ➔ Feb 2026

Trial completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • CHI3L1 • GFAP

Preclinical efficacy and rationale of targeting lysine280-acetylated tau for Alzheimer’s disease therapy with ADEL-Y01, humanized monoclonal antibody (AAIC 2024) - "Based on our observations that tau-acK280 is a core species involved in seeding and propagation activities, the Y01 antibody that specifically recognizes acK280 represents a promising therapeutic candidate for AD and other neurodegenerative diseases associated with tauopathy. ADEL-Y01 is currently undergoing a phase-1 clinical trial in the United States through a collaborative effort between ADEL and Oscotec."

Preclinical • Alzheimer's Disease • CNS Disorders

Oscotec/ADEL Initiates First-in-Human Dosing in Ph1 of Anti-MTBR Tau Antibody ADEL-Y01 In Alzheimer's Disease (PRNewswire) - "Oscotec Inc. and ADEL Inc. announced the dosing of the first healthy participant in its first-in-human study of ADEL-Y01 for the treatment of Alzheimer's disease (AD)....This phase 1a/1b study in the U.S. is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ADEL-Y01 in 40 healthy volunteers as well as in 33 participants with Mild Cognitive Impairment due to Alzheimer's disease or mild Alzheimer's disease."

Trial status • Alzheimer's Disease

A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01 (clinicaltrials.gov) - P1 | N=73 | Recruiting | Sponsor: Alzheimer's Disease Expert Lab (ADEL), Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • GFAP • p-tau181

A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01 (clinicaltrials.gov) - P1 | N=73 | Not yet recruiting | Sponsor: Alzheimer's Disease Expert Lab (ADEL), Inc.

New P1 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • GFAP • p-tau181

Oscotec/ADEL Announce FDA Clearance of IND Application of ADEL-Y01 for the Treatment of Alzheimer's Disease (PRNewswire-Asia) - "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....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."

IND • New P1 trial • Alzheimer's Disease