DMOAD (Disease-Modifying Osteoarthritis Drug)
With the growth of the osteoarthritis (OA) market worldwide, there is an ever-increasing need for an advanced medical solution that can halt or slow the progression of the disease. Current therapies focus on decreasing pain and are only effective for short periods of time. In developing TG-C, Kolon TissueGene seeks to create a disease-modifying osteoarthritis drug (DMOAD) that may provide an alternative to traditional treatment and surgery, or which may delay the progression of OA to minimize the need for multiple surgical interventions.
Kolon TissueGene is committed to improving OA pain and knee function and demonstrating the benefits within the structure of the knee joint, to interrupt the vicious cycle of inflammation and slow the process of cartilage degradation.
During a planned national U.S. Phase III clinical trial, Kolon TissueGene plans to further support a two-year improvement of pain and function, as was demonstrated through the concluded U.S. Phase II clinical trial.
Additionally, the company has designed the trial to seek a disease-modifying osteoarthritis drug (DMOAD) designation for TG-C from the U.S. Food and Drug Administration (FDA). A delay in structural progression will be evaluated radiographically and by biomarkers as part of the Phase III program - potentially making TG-C the first therapy to receive a DMOAD label.