Kolon TissueGene’s TG-C, a new gene therapy drug for osteoarthritis, has completed the final phase of the U.S. Food and Drug Administration’s (FDA) phase 3 clinical trial. “After the Phase 3 dosing, only the final steps of follow-up and product approval remain,” said the company on July 11.
FDA clinical trials consist of three phases. Phase 1 tests the drug’s safety in a small number of healthy volunteers, phase 2 evaluates the drug’s effectiveness in approximately 100 to 300 volunteers, and phase 3 examines whether the drug offers treatment benefits to a specific population, typically involving 300 to 3,000 participants.
TG-C, known in South Korea as Invossa, is a drug developed by Kolon TissueGene, a subsidiary of Kolon Life Sciences. It was heralded as the world’s first gene therapy drug for patients with degenerative joint disease and received approval from Korea’s Ministry of Food and Drug Safety in 2017. However, health authorities canceled the drug’s license after the FDA discovered that the company mislabeled a key ingredient used in the drug, halting U.S. clinical trials.
The FDA lifted the “clinical hold” on the phase 3 clinical trial of Invossa in 2020 after Kolon TissueGene submitted supplementary data related to the mislabeling of ingredients, and patient recruitment began the following year. “More than 6,800 patients volunteered to participate in the phase 3 clinical trial in the U.S., and it took more than three years to select 1,020 patients who met the clinical criteria,” the company said. “The phase 3 patient dosing was completed on July 10, which comes 18 years after starting phase 1 clinical trials in 2006.”
The company will monitor the patients for two years, and based on the results, will begin the process of applying for FDA marketing authorization. “If all goes according to plan, we expect the product to be available in the U.S. in 2028,” the company said.
