Kolon TissueGene completes Phase 3 trial dosing of osteoarthritis drug in U.S.

[Courtesy of Kolon TissueGene]

Kolon TissueGene’s osteoarthritis gene therapy, TG-C (Invossa), is on the brink of making a significant comeback as a global pharmaceutical product, overcoming past controversies over its cell origins that led to marketing license revocation in South Korea.

On Wednesday, the company announced the successful completion of a Phase 3 trial for the therapy. This milestone comes 18 years after receiving approval from the Food and Drug Administration (FDA) in 2006 to begin Phase 1 trials in the U.S., and a decade after starting Phase 3 trials in 2014.

The trial’s completion also follows the lifting of the FDA’s clinical trial held in 2020.

The Phase 3 trial marks the first time a Korean company has conducted a clinical trial involving over 1,000 knee osteoarthritis patients in the United States.

According to Kolon TissueGene, more than 6,800 hopeful participants expressed interest in joining the trial, with 1,000 eligible patients participating across 80 hospitals nationwide.

Despite challenges such as the Covid-19 pandemic, the company completed the enrollment of the targeted 1,020 patients by June this year. The final dosing of patients was concluded on Wednesday.

Kolon TissueGene will now embark on a two-year follow-up period, monitoring the treated patients. During this time, clinical trial participants will regularly visit hospitals for assessments, and the results will be disclosed after the follow-up period concludes.

Simultaneously, Kolon TissueGene is preparing for FDA approval, aiming to expedite the market authorization of TG-C in the U.S.

The company has already initiated preparations for commercial production, collaborating with Lonza, a leading CDMO, and Kolon Life Science’s subsidiary, Kolon Biotech.

TG-C, the world’s first gene therapy for osteoarthritis, initially garnered significant attention globally.

However, controversy erupted in March 2019 during the U.S. Phase 3 trial when one of its key components was found to be derived from kidney cells, not human cartilage cells as originally stated in the clinical plan.

Korean courts upheld the revocation of its authorization in both the first and second trials, and a third trial is currently underway in the Supreme Court.

Nevertheless, the U.S. FDA accepted Kolon TissueGene’s explanation and lifted the clinical hold in April 2020, allowing the Phase 3 trials to resume.