Kolon TissueGene Completes Dosing in Two Key US Phase III Trials for TG-C

Kolon TissueGene, Inc. announced the completion of patient dosing in its US Phase 3 clinical trials for Knee Osteoarthritis (OA). This marks a significant milestone for the company in its efforts to introduce TG-C, an innovative cell and gene therapy, to the market. After resuming patient recruitment in November 2021, the company successfully managed to dose 1,066 patients over approximately 30 months.

The successful completion of this phase was made possible after the US Food and Drug Administration (FDA) lifted a clinical hold in April 2020. This hold was removed following thorough research and a rigorous regulatory review process. Despite facing delays brought about by the global pandemic, the company persevered, showcasing its determination to develop the world’s first cell and gene therapy for knee osteoarthritis.

During the recruitment phase, around 6,700 individuals expressed interest in participating, with over 1,000 meeting the criteria for enrollment in the trials. Moving forward, the company will conduct a two-year follow-up to assess the safety and efficacy of TG-C. The results of these trials will be published after this follow-up period.

Concurrently, Kolon TissueGene is preparing a Biologics License Application (BLA) for submission to the FDA. This submission is crucial for obtaining marketing authorization for TG-C in the US. The company has already initiated preparations related to commercial production and is collaborating with Lonza, a leading pharmaceutical CDMO, to facilitate this process.

Moon Jong Noh, PhD, CEO of Kolon TissueGene, expressed optimism about the outcome of the Phase 3 trials, drawing confidence from the success of the previous Phase 2 trials. He highlighted the company's readiness to engage with potential partners for commercial sales and marketing once the trials are completed and the BLA is submitted. Furthermore, he reaffirmed the commitment of all company executives and employees to deliver meaningful results to their customers and shareholders.

Kolon TissueGene, Inc. specializes in advanced cell therapies and has developed TG-C, a first-in-class cell and gene therapy for knee OA. TG-C is designed to offer pain relief, enhance mobility, and potentially slow the progression of osteoarthritis. The therapy involves a single intra-articular injection and has shown promising results in both US and international clinical trials.

The Phase 3 trials aim to support these findings and possibly secure a disease-modifying osteoarthritis drug (DMOAD) designation from the FDA. This designation would mark TG-C as the first therapy to receive such a label, targeting the modification of the disease course of osteoarthritis. The company is conducting these trials under a Special Protocol Assessment (SPA) agreement with the FDA, indicating a collaborative effort in ensuring the efficacy and safety of TG-C.

In summary, Kolon TissueGene, Inc. has made significant strides in its clinical trials for TG-C, bringing it closer to offering a groundbreaking treatment for knee osteoarthritis. The completion of patient dosing in the Phase 3 trials is a critical step towards achieving regulatory approval and commercializing this innovative therapy.