Kolon TissueGene Completes Dosing in Major Knee Osteoarthritis Trials

Successful Completion of Patient Dosing

Kolon TissueGene has announced the completion of patient dosing in their Phase 3 clinical trials for a new knee osteoarthritis treatment. The trials took place in the US and covered over 1,000 patients over the course of about 30 months.

This significant milestone was achieved despite regulatory and pandemic-related delays, marking a crucial step towards the eventual approval and commercialization of this innovative therapy.

Overcoming Challenges

The clinical trials initially faced delays due to a clinical hold by the US FDA, which was later lifted in April 2020. This allowed the company to continue with its trial recruitment and dosing processes.

Even with the global pandemic causing further delays, effective teamwork and dedication enabled Kolon TissueGene to successfully dose the required number of patients.

Next Steps in the Process

All dosed patients will be followed for two years to determine the treatment's safety and effectiveness. This follow-up period is crucial to gather comprehensive data on the outcomes of the therapy.

Alongside the follow-up, the company is preparing its Biologics License Application (BLA) for submission to the FDA to obtain marketing approval in the US.

Implications for Knee Osteoarthritis Treatment

TG-C, the therapy under investigation, is a first-of-its-kind cell and gene treatment for knee osteoarthritis. It has shown promising results in earlier trials, including pain reduction and increased mobility.

If approved, TG-C could potentially transform the management of knee osteoarthritis, providing an alternative to traditional treatments and surgeries.

Looking Forward

Kolon TissueGene is hopeful that the trial results will mirror the success of earlier Phase 2 trials, which showed significant improvements in patient pain levels and joint function over two years.

The company is also working on establishing partnerships for the commercial sales and marketing of TG-C, pending its approval.