OCH-NCNP1 / National Center of Neurology and Psychiatry, Eisai - LARVOL DELTA

Phase ? Clinical Trial of NKT Cell-targeting Glycolipid OCH-NCNP1 for Patients with Relapsing Multiple Sclerosis (AAN 2024) - "OCH is a promising treatment for multiple sclerosis, especially for SPMS."

Clinical • CNS Disorders • Multiple Sclerosis • CSF2 • IL4

Phase II Trial of new MS Therapies (ACTRIMS Forum 2024) - "Background: First-in-human clinical trial of OCH, orally administered to healthy subjects and MS patients has demonstrated immunoregulatory effects through activation of invariant NKT cells.Objectives: To investigate the efficacy and safety of the glycolipid OCH-NCNP1 (OCH), in patients with relapsing MS (RMS) including those with or without progression-independent relapse activity (PIRA) . A randomized, placebo-controlled study was conducted with a placebo group (n=15) and an OCH group (n=15) in 30 RMS patients... Relapsing MS patients with and without PIRA responded differentially to OCH treatment, as judged by suppressed frequency of relapses in PIRA+ patients. Analysis for this unexpected result as well as evaluation of the efficacy of OCH in SPMS appears to be rewarding in the future."

P2 data • Multiple Sclerosis • CD4 • CSF2 • IL4

Efficacy and Safety of the Natural Killer T Cell-Stimulatory Glycolipid OCH-NCNP1 for Patients With Relapsing Multiple Sclerosis: Protocol for a Randomized Placebo-Controlled Clinical Trial. (PubMed, JMIR Res Protoc) - P2 | "This randomized controlled trial will determine whether OCH-NCNP1 is effective and safe in patients with MS as well as provide evidence for the potential of OCH-NCNP1 as a therapeutic agent for MS."

Clinical • Journal • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rare Diseases • CD4 • IL4

Phase II Clinical Trial of OCH-NCNP1 (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: National Center of Neurology and Psychiatry, Japan | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Multiple Sclerosis

Phase Ⅱ Clinical Trial of NKT Cell-Targeting Glycolipid OCH-NCNP1 for Patients with Relapsing Multiple Sclerosis (MSMilan 2023) - "OCH is a promising treatment for multiple sclerosis, especially for SPMS."

Clinical • CNS Disorders • Multiple Sclerosis • CSF2 • IL4

Phase II Clinical Trial of OCH-NCNP1 (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: National Center of Neurology and Psychiatry, Japan | Enrolling by invitation ➔ Active, not recruiting | Trial completion date: Aug 2022 ➔ May 2023 | Trial primary completion date: Aug 2022 ➔ May 2023

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

Phase II Clinical Trial of OCH-NCNP1 (clinicaltrials.gov) - P2 | N=30 | Enrolling by invitation | Sponsor: National Center of Neurology and Psychiatry, Japan | Trial completion date: Nov 2021 ➔ Aug 2022 | Trial primary completion date: Oct 2021 ➔ Aug 2022

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

Phase II Clinical Trial of OCH-NCNP1 (clinicaltrials.gov) - P2; N=30; Enrolling by invitation; Sponsor: National Center of Neurology and Psychiatry, Japan; Trial completion date: Oct 2020 ➔ Nov 2021; Trial primary completion date: Sep 2020 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis • MRI