SAR449548 / Oscotec, ADEL, Sanofi - 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=42 | Terminated | Sponsor: Alzheimer's Disease Expert Lab (ADEL), Inc. | N=73 ➔ 42 | Trial completion date: Jul 2027 ➔ Jan 2026 | Suspended ➔ Terminated | Trial primary completion date: Jun 2027 ➔ Jan 2026; Study discontinued due to sponsor transition and strategic decision not to continue the protocol.

Enrollment change • First-in-human • Trial completion date • Trial primary completion date • Trial termination • Alzheimer's Disease • CNS Disorders • Cognitive 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 | Suspended | Sponsor: Alzheimer's Disease Expert Lab (ADEL), Inc. | Recruiting ➔ Suspended

First-in-human • Trial suspension • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

[Interview] ADEL, Sanofi bet on tau precision as Alzheimer’s drug race shifts beyond amyloid (Korea Biomedical Review) - "ADEL-Y01, its lead Alzheimer’s candidate, has completed phase 1a and is now dosing in phase 1b, Yoon said...ADEL is now trying to turn the Sanofi deal into its next milestone."

Trial status • Alzheimer's Disease

First-in-Human Study of ADEL-Y01, a Monoclonal Antibody Targeting Acetylated Tau (acK280) in the MTBR: Safety and Pharmacokinetics in Healthy Adults and Early Alzheimer's Disease (CTAD 2025) - No abstract available

Clinical • First-in-human • P1 data • PK/PD data • Alzheimer's Disease • CNS Disorders

ADEL reports CNS-penetrating tau antibody ADEL-Y01 shows safety in phase 1a trial (Korea Biomedical Review) - "According to ADEL, the single- and multiple-dose phase 1a study in healthy adults confirmed overall favorable safety and tolerability. Pharmacokinetic (PK) exposure was observed in both blood and cerebrospinal fluid (CSF) in a dose-dependent manner, providing initial evidence of central nervous system (CNS) penetration....ADEL is currently conducting a phase 1b multiple-dose clinical trial of ADEL-Y01 in the U.S. for patients with mild cognitive impairment (MCI) and mild Alzheimer’s disease."

First-in-human • P1 data • 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. | 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