ICM-203 / Yonsei Technology Holdings, LG Chem - LARVOL DELTA

Interim Analysis of a Phase 1/2a Study of ICM-203 AAV Gene Therapy for Osteoarthritis (ASGCT 2025) - P1/2 | "Intra-articular injections of ICM-203 were safe and well tolerated. ICM-203 appeared to show greater therapeutic activity over placebo in subjects with negative NAb at baseline. Current findings indicate ICM-203 may demonstrate potential as a disease-modifying osteoarthritis drug (DMOAD), between reducing osteoarthritis symptoms, ameliorating structural joint damage, and alleviating synovial inflammation."

Gene therapy • P1/2 data • Gene Therapies • Immunology • Inflammation • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis (clinicaltrials.gov) - P1/2 | N=16 | Active, not recruiting | Sponsor: ICM Biotech Australia Pty Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Mar 2025 ➔ Mar 2026

Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A Study Evaluating the Safety, Tolerability, and Activity of ICM-203 in Subjects With Knee Osteoarthritis. (clinicaltrials.gov) - P1/2 | N=18 | Not yet recruiting | Sponsor: ICM Co. Ltd. | Trial completion date: Nov 2026 ➔ Nov 2027 | Trial primary completion date: May 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis (clinicaltrials.gov) - P1/2 | N=16 | Recruiting | Sponsor: ICM Biotech Australia Pty Ltd. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Mar 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

INTERIM DATA FROM THE FIRST-IN-HUMAN PHASE 1/2A TRIAL OF ICM-203, AN INTRA-ARTICULAR, AAV GENE THERAPY FOR OSTEOARTHRITIS - SAFETY, TOLERABILITY, AND PRELIMINARY EVALUATION OF CLINICAL ACTIVITY IN LOW DOSE COHORT (OARSI 2024) - "Purpose (the aim of the study): This first-in-human phase 1/2a study is being conducted to assess the safety, tolerability, and activity of ICM-203, a recombinant adeno-associated viral (AAV) vector designed to express a truncated form of human Nkx3.2, a transcription factor which plays an important role in both chondrocyte and synoviocyte activity."

Clinical • Gene therapy • P1/2 data • Gene Therapies • Immunology • Osteoarthritis • Pain • Rheumatology

Interim Review of Safety, Tolerability, and Efficacy From a First-In-Human Phase 1/2a Clinical Study of ICM-203, an Intra-Articular, AAV Gene Therapy for Osteoarthritis (ASGCT 2024) - P1/2 | "Intra-articular injections of ICM-203 6x1012 vg or placebo were safe and well tolerated. Improvement in joint pain and/or function were observed in 6 of 8 subjects. Favorable structural changes were observed on MRI, such as preservation of cartilage thickness, decrease in BML, and improvement in synovitis in subjects with more inflammation at baseline."

Clinical • Gene therapy • P1/2 data • Review • Gene Therapies • Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoarthritis • Pain • Rheumatology

A Study Evaluating the Safety, Tolerability, and Activity of ICM-203 in Subjects With Knee Osteoarthritis. (clinicaltrials.gov) - P1/2 | N=18 | Not yet recruiting | Sponsor: ICM Co. Ltd. | Trial completion date: Nov 2025 ➔ Nov 2026 | Trial primary completion date: May 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis (clinicaltrials.gov) - P1/2 | N=16 | Recruiting | Sponsor: ICM Biotech Australia Pty Ltd. | Trial completion date: Jun 2024 ➔ Dec 2024

Trial completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Safety and Biodistribution Study of Intra-Articular Delivered ICM-203, an AAV Gene Therapy Vector for Osteoarthritis, in Normal Rodents and Osteoarthritis-Induced Beagle Dogs (ASGCT 2023) - "In addition, no abnormalities were found in terms of immunogenicity. Overall, these results were included in the ICM-203 IND submission and the program received no study hold comment from the US FDA in Oct 2022."

Gene therapy • Preclinical • Gene Therapies • Hematological Disorders • Immunology • Inflammation • Osteoarthritis • Pain • Rheumatology • IFNG

A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo (clinicaltrials.gov) - P=N/A | N=16 | Enrolling by invitation | Sponsor: ICM Co. Ltd. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Immunology • Osteoarthritis • Pain • Rheumatology

A Study Evaluating the Safety, Tolerability, and Activity of ICM-203 in Subjects With Knee Osteoarthritis. (clinicaltrials.gov) - P1/2 | N=18 | Not yet recruiting | Sponsor: ICM Co. Ltd. | Trial completion date: May 2025 ➔ Nov 2025 | Initiation date: May 2023 ➔ Nov 2023 | Trial primary completion date: Nov 2024 ➔ May 2024

Trial completion date • Trial initiation date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A Long Term Follow-up Study of Subjects Who Received ICM-203 or Matching Placebo (clinicaltrials.gov) - P=N/A | N=16 | Not yet recruiting | Sponsor: ICM Co. Ltd.

New trial • Immunology • Osteoarthritis • Pain • Rheumatology

A Study Evaluating the Safety, Tolerability, and Activity of ICM-203 in Subjects With Knee Osteoarthritis. (clinicaltrials.gov) - P1/2 | N=18 | Not yet recruiting | Sponsor: ICM Co. Ltd. | Trial completion date: Dec 2024 ➔ May 2025 | Initiation date: Dec 2022 ➔ May 2023 | Trial primary completion date: Jun 2024 ➔ Nov 2024

Trial completion date • Trial initiation date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis (clinicaltrials.gov) - P1/2 | N=16 | Recruiting | Sponsor: ICM Biotech Australia Pty Ltd. | N=24 ➔ 16 | Trial completion date: Sep 2023 ➔ Jun 2024 | Trial primary completion date: Jun 2023 ➔ Mar 2024

Enrollment change • Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A Study Evaluating the Safety, Tolerability, and Activity of ICM-203 in Subjects With Knee Osteoarthritis. (clinicaltrials.gov) - P1/2 | N=24 | Not yet recruiting | Sponsor: ICM Co. Ltd. | Trial completion date: Jun 2024 ➔ Dec 2024 | Trial primary completion date: Mar 2024 ➔ Jun 2024

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

A Study Evaluating the Safety, Tolerability, and Active Doses of ICM-203 in Subjects With Knee Osteoarthritis. (clinicaltrials.gov) - P1/2 | N=24 | Not yet recruiting | Sponsor: ICM Co. Ltd.

New P1/2 trial • Immunology • Osteoarthritis • Pain • Rheumatology

A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: ICM Biotech Australia Pty Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Osteoarthritis • Pain • Rheumatology