A Phase 3 clinical trial of Kolon TissueGene's investigational cell-based gene therapy, TG-C, has failed to meet its two primary endpoints in people with knee osteoarthritis.
The ACTiVION-II trial enrolled 531 participants across 27 sites in the USA. Patients received a single injection of TG-C or placebo and were assessed after 12 months. The study found no statistically significant differences between the treatment and placebo groups for either knee pain or physical function.
The company said it will wait for results from its second ongoing phase 3 study, ACTiVION-III, which are expected in October 2026, before deciding on the future development of TG-C.
Fierce Biotech has more details.