Invossa Authorized to Enter Phase 3 Clinical Trial in US

Invossa, South Korea’s first gene therapy for knee osteoarthritis developed by the Kolon Group, has crossed the final threshold for the phase 3 clinical trial in the US.

Kolon TissueGene, an affiliate of the Kolon Group, announced on July 6 that the company has got approval of its use of the clinical samples from the US Food and Drug Administration (FDA) and will start the phase 3 clinical trial in the US in earnest.

Since getting approval of its phase 3 clinical trial from the FDA in May 2015, Kolon TissueGene has undergone the process for getting approval of the sample use according to the guidelines suggested by the FDA. Now, the company can embark on a full-scale phase 3 clinical trial, including injections of Invossa into patients and observing the responses.

The clinical trial of Invossa in the US will be conducted on around 1,020 patients in more than 50 medical organizations. The company plans to start enrollment of patients and injection of Invossa just after signing agreements with hospitals and completing the discussions with their internal investigation committee.

In particular. Kolon TissueGene aims to prove the potential of Invossa as a fundamental treatment for knee osteoarthritis through the large scale clinical trials in the US. According to the company, Invossa is thought to be effective not only in relieving the pain due to osteoarthritis but also in treating the damaged cartilage, the basic cause of knee osteoarthritis.

In South Korea, Invossa has been on sale just for the use of relieving pains and inhibiting the damages to knee joint area. But in the US, Kolon intends to win the recognition of a disease-modifying osteoarthritis drug (DMOAD) for Invossa. DMOAD refers to a drug that inhibits structural disease progression and ideally also improves symptoms and/or function. There are currently no licensed DMOAD.

The company started research on Invossa in 1999 and got the license to sell the gene therapy in the local market in 2017. In seven months after its launch, Invossa procedures exceeded 1,000 cases.

But Lee Woong-ryeol, chairman of the Kolon Group, is targeting the global market. Lee established TissueGene (currently Kolon TissueGene) not in South Korea but in the US in 1999, aiming to create a global blockbuster drug from the very beginning.

As the clinical trial is expected to take about three years, Invossa will be launched in the US market around 2022 if the trial proceeds as planned.