Juniper Biologics, a science-led healthcare company focused on researching, developing and commercializing novel therapies announced that it has gained the licensing rights to develop and commercialize TG-C LD (TissueGene-C low dose) for the treatment of knee osteoarthritis.
TG-C LD is a non-surgical investigational treatment that has been hailed as the world’s first cell-mediated gene therapy for osteoarthritis of the knee,[i] which is the most common form of arthritis.[ii] According to research, osteoarthritis is estimated to be the eleventh[1] leading cause of disability worldwide with an estimated 300 million patients in Asia Pacific and Middle East and Africa alone, suffering from the debilitating effects of the degenerative joint disease. It is one of the biggest unmet medical needs among musculoskeletal conditions with the risk demonstrated to increase with age[iii].
A first-in-class cell-mediated gene therapy, TG-C LD targets knee osteoarthritis through a single intra-articular injection. Kolon TissueGene, the license holder for TG-C in the United States (not TG-C LD), has already completed a phase 2 clinical trial in the United States, with initial data demonstrating sustained pain relief and mobility improvement following a single injection in the knee joint, for possibly up to 2 years. Phase 3 clinical trials in the United States comprising 1,020 patients are currently ongoing to confirm the safety and efficacy of TG-C. In addition to confirm the statistically significant pain reduction and function improvements observed from the US Phase 2 clinical trial, the trials are designed to show the delay of disease progression to achieve a DMOAD (Disease Modifying Osteoarthritis Drug) designation.
Juniper Biologics CEO, Raman Singh, said: “We are always looking to identify areas in which we can make the most difference and TG-C LD offers substantial relief for knee osteoarthritis patients who would otherwise be in need of surgery or other treatment options. We are committed to providing innovative treatments to treat osteoarthritis of the knee through the regeneration of cartilage and we believe this innovative investigational treatment will bring relief to millions of patients across the region.”