Kolon resumes Invossa phase 3 clinical trials in US

Kolon TissueGene Inc., the cell therapies unit of South Korean pharmaceutical company Kolon Life Science Inc., said on Dec. 28 it has resumed administering Invossa (TissueGene-C), a cell and gene therapy for osteoarthritis, for knee osteoarthritis in phase 3 clinical trials in the US. The clinical trials will be conducted in about 80 medical institutions for 1,020 patients. The Korean pharmaceutical company will complete the testing administration by 2023. 

The Ministry of Food and Drug Safety (MFDS) of Korea approved the drug in July 2017 as a cell and gene therapy for patients with degenerative joint disease. However, the health authorities canceled the drug licensing in March 2019, following a scandal that Kolon had manufactured the drug with a main ingredient different from that labeled at the time of approval.

According to the MFDS, the drug was labeled as using cartilage-derived cells, but it was actually using kidney-derived cells. In May 2019, the US Food and Drug Administration suspended the drug’s phase 3 clinical trials.

Kolon Life Science appealed to suspend the execution of MFDS’ order to stop manufacturing Invossa, however, the Seoul Central District Court dismissed the appeal in February of this year. 

In April 2020, FDA allowed Kolon TissueGene to resume clinical trials of Invossa after reviewing supplementary data from the Korean firm, including an explanation of how the drug composition has changed and additional data on the cell ingredients. Earlier this month, FDA approved Invossa’s phase 2 clinical trial for hip joint osteoarthritis, for the drug’s target expansion. 

“We expect a positive result from the phase 3 clinical trials as the scientific data from phase 1 and 2 clinical trials have high reliability and validity. By completing the clinical study successfully, we will make Invossa a game-changer in the global osteoarthritis therapy market,” said Kolon TissueGene Chief Executive Sung Han.

Write to Ju-Hyun Lee at deep@hankyung.com
Jihyun Kim edited this article.