Kolon TissueGene's 'TG-C' Targets Spinal Discs Beyond Knee and Hip Joints

Kolon TissueGene announced on the 18th that it has received approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application of its osteoarthritis cell and gene therapy (CGT) ‘TG-C’ for degenerative disc disease (DDD).

Kolon TissueGene logo
Photo by Kolon TissueGene

Kolon TissueGene received approval just over a month after submitting the IND for TG-C’s spinal indication last month, following two years of preclinical studies including animal testing. With this IND approval, it is expected that TG-C’s indications can be expanded to spinal diseases in addition to the ongoing Phase 3 knee joint and Phase 2 hip joint clinical trials in the U.S. Furthermore, since the spine has a different mechanism of action (MoA) compared to the existing knee and hip joints, this expansion of indications holds significance beyond just broadening the scope.

The Phase 1 clinical trial for TG-C’s DDD will be conducted at up to six hospitals in the U.S. The trial will evaluate the safety, tolerability, and efficacy of TG-C in 24 patients. The clinical period will include follow-up observations for up to 24 months from the time the last patient receives the treatment.

According to the World Health Organization (WHO), approximately 600 million people worldwide currently suffer from low back pain due to spinal diseases, and chronic low back pain affects about 5-13% of the adult population. BRUDER, a U.S.-based medical consulting firm, estimates that by 2025, about 2 million people in the U.S. will be direct candidates for TG-C’s spinal indication.

Hansungsoo, CEO of Kolon TissueGene, said, “The approval of this spinal disease clinical trial reaffirms TG-C’s versatility in various therapeutic areas. Moving forward, we plan to leverage TG-C’s strengths to implement patient- and market-centered strategies while maximizing its utility, focusing on clinical trials for degenerative diseases.”

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