cupabimod (AMG0103) / AnGes MG, Shionogi - LARVOL DELTA

NF-kappa B Oligo DNA Decoy Provides 12 Months of Pain Relief and Disc Height Restoration for Patients with Chronic Discogenic Low Back Pain - a Randomized Clinical Trial. (PubMed, Spine J) - "A single intradiscal injection of AMG0103 demonstrated clinically meaningful and statistically significant improvements in back pain, disc height and patient satisfaction throughout 1 year. Further investigation in a larger patient population is warranted."

Clinical • Journal • Back Pain • Hematological Disorders • Lumbar Back Pain • Musculoskeletal Pain • Pain

NF-κB decoy oligo DNA has started phase 2 clinical trial for discogenic low back pain [Google translation] (Kabutan - Minkabu The Infonoid) - "The first two patients were administered 20.0mg, the maximum dose in this study, and after confirming safety and tolerability, they were divided into three groups: 10mg group, 20mg group, and placebo group, and a comparative study was conducted. implement. The dose of 20.0 mg was set because it has been confirmed in animal experiments that there are no safety issues, and there is a possibility that higher efficacy can be expected. The observation period will be 12 months, and efficacy will be evaluated by looking at changes in the NRS score, which is an indicator of 'pain'. If all goes well, the results of the phase 2 clinical trial are expected to be obtained around 2026, and if the results are favorable, the company will conclude a license agreement and discuss the next stage of development with Shionogi & Co."

Trial status • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain (clinicaltrials.gov) - P1b; N=25; Completed; Sponsor: AnGes, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Back Pain • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain • MRI

AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain (clinicaltrials.gov) - P1b; N=24; Recruiting; Sponsor: AnGes, Inc.; Trial completion date: Feb 2020 ➔ Feb 2021; Trial primary completion date: Aug 2019 ➔ Feb 2020

Clinical • Trial completion date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain • MRI

AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain (clinicaltrials.gov) - P1b; N=25; Active, not recruiting; Sponsor: AnGes, Inc.; Recruiting ➔ Active, not recruiting; Trial primary completion date: Feb 2020 ➔ Sep 2020

Clinical • Enrollment closed • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain • MRI

AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain (clinicaltrials.gov) - P1b; N=24; Recruiting; Sponsor: AnGes, Inc.; Not yet recruiting ➔ Recruiting; Initiation date: Jan 2018 ➔ Feb 2018

Clinical • Enrollment open • Trial initiation date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain • MRI

AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain (clinicaltrials.gov) - P1b; N=24; Not yet recruiting; Sponsor: AnGes, Inc.

Clinical • New P1 trial • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain • MRI

AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain (clinicaltrials.gov) - P1b; N=24; Not yet recruiting; Sponsor: AnGes, Inc.; Initiation date: Aug 2017 ➔ Jan 2018; Trial primary completion date: Mar 2019 ➔ Aug 2019

Clinical • Trial initiation date • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain • MRI

AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain (clinicaltrials.gov) - P1b; N=25; Active, not recruiting; Sponsor: AnGes, Inc.; Trial primary completion date: Sep 2020 ➔ Feb 2021

Clinical • Trial primary completion date • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain • MRI