NS101 / Neuracle Sci, Reyon Pharma - LARVOL DELTA

A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients (clinicaltrials.gov) - P1/2 | N=138 | Recruiting | Sponsor: Neuracle Science Co., LTD. | Trial completion date: Jun 2025 ➔ Jan 2027 | Trial primary completion date: Jun 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Otorhinolaryngology

Inhibition of FAM19A5 reverses synaptic loss and cognitive decline in mouse models of Alzheimer's disease. (PubMed, Alzheimers Res Ther) - P1 | "This study demonstrated that inhibiting FAM19A5 function with an anti-FAM19A5 antibody restores synaptic integrity and enhances cognitive function in AD, suggesting a novel therapeutic strategy for AD."

Journal • Preclinical • Alzheimer's Disease • CNS Disorders

Professor Sung Jae-young presents a treatment strategy for Alzheimer's disease with the new drug candidate NS101. [Google translation[ (Nate) - "The research team discovered that 'FAM19A5,' a protein secreted by brain cells, is the cause of synaptic dysfunction and developed 'NS101,' an antibody therapeutic candidate that suppresses this...When the research team administered NS101 to mice with Alzheimer's disease, damaged synapses were restored, and memory and learning ability were noticeably improved....'We plan to gradually verify the effects of NS101 through follow-up clinical trials.'"

Preclinical • Alzheimer's Disease

A Phase 1b/2a, Study Evaluating the Safety, PK/PD and Efficacy of NS101 in Healthy Volunteers and SSNHL Patients (clinicaltrials.gov) - P1/2 | N=118 | Recruiting | Sponsor: Neuracle Science Co., LTD.

New P1/2 trial • Otorhinolaryngology

A FIH Study to Assess the Safety and Tolerability of NS Intravenous NS101 Infusion (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Neuracle Science Co., LTD. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders

A FIH Study to Assess the Safety and Tolerability of NS Intravenous NS101 Infusion (clinicaltrials.gov) - P1 | N=64 | Active, not recruiting | Sponsor: Neuracle Science Co., LTD. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders

A FIH Study to Assess the Safety and Tolerability of NS Intravenous NS101 Infusion (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Neuracle Science Co., LTD. | N=48 ➔ 64

Enrollment change • CNS Disorders