Kolon TissueGene said it has resumed administering Invossa (TG-C), cell-mediated gene therapy for osteoarthritis, in phase 3 clinical trials for knee osteoarthritis in the United States.
The medication began in Source Healthcare in Santa Monica, Calif. The company plans to complete the trials of Invossa by 2023 after giving the therapy to 1,020 patients at about 80 medical institutions in the U.S.
In March 2019, when one of the active ingredients of Invossa was found to be different from the approved, the regulators canceled the license for Invossa in Korea. The U.S. also temporarily suspended the phase 3 clinical trials for treating patients with knee osteoarthritis.
In April 2020, the U.S. Food and Drug Administration (FDA) notified Kolon TissuGene that it would lift the clinical hold issued on Invossa, granting another opportunity for the company to continue its studies.
TissueGene-C (TG-C) therapy is a new biopharmaceutical injection that can deliver the drug directly to the knee joint cavity, different from existing surgery, narcotic analgesics, and physical therapy for treating knee osteoarthritis.
Kolon TissueGene explained that the clinical trials of TG-C are designed to win approval as a disease-modifying osteoarthritis drug (DMOAD). This therapy can fundamentally improve joint structure and control pain with functional improvement. Unfortunately, there is no available DMOAD recognized worldwide yet.
“The phase 3 clinical trials of Invossa are expected to show positive outcomes as the phase 1 and 2 studies resulted in valid and reliable data,” Kolon TissueGene CEO Han Sung-soo said. “We will complete clinical trials and emerge as a game-changer in the global osteoarthritis market.”
The U.S. is estimated to have more than 38 million osteoarthritis patients, and about 20 million of them received a prescription for knee osteoarthritis.
GlobalData, a U.K. data analytics and consulting firm, has forecast the global osteoarthritis market to grow 8.26 percent annually, from $7.6 billion in 2021 to $9.2 billion in 2024.