Kolon starts phase 3 tests of arthritis drug in U.S.

Kolon TissueGene announced Tuesday that it will start phase 3 clinical tests of Invossa, a gene therapy drug for knee osteoarthritis, in the United States this fall, inching one step closer to launching the medicine in the U.S. market.

Last week, the biopharmaceutical arm of Korea’s Kolon Group received approval from the U.S. Food and Drug Administration (FDA) to conduct phase 3 trials, which is the last clinical research process before its commercial release. A total of 1,020 U.S. patients from 60 major hospitals will take part.

“We will start injections between September and October, and we aim to receive an FDA permit for commercial sales in 2021,” said Lee Woo-sok, the CEO of Kolon TissueGene and Kolon Life Science, at a press conference held Tuesday at Kolon Life Science’s headquarters in western Seoul.

Kolon TissueGene, based in the United States, develops and sells cell and gene treatment. Kolon Life Science is a local affiliate that has sales rights for TissueGene’s products in Asia.

Invossa, which is injected using a needle, is the first gene therapy that treats osteoarthritis, a common form of arthritis. Patients with the condition suffer from knee pain and difficulty moving due to degeneration of the joint between the bones.

Since 2007, Invossa has passed through four clinical tests in Korea and two in the United States. Patients saw improvements in pain and knee function for two years with a single injection of Invossa. In Korea, the drug was approved for commercial sales in July 2017 and launched in November of that year.

According to Lee, the two-year effect is meaningful, as osteoarthritis negatively affects patients’ quality of life, which experts have found can lead to psychological problems such as depression.

Invossa’s main target is patients in the “treatment gap,” who seek long-lasting treatment but are too young to receive surgery.

Osteoarthiritis develops over time. Early-stage patients that experience pain occasionally endure it with painkillers or temporary lubricants like hyaluronic acid and steroids. The effects of these treatments only last up to a few months.

Over time, pain can become more chronic, and many patients seek more permanent treatment. But doctors only advise surgery for patients over age 65, as its effect only lasts for about a decade.

Kolon is also preparing to obtain FDA approval for Invossa as a disease modifying osteoarthritis drug (Dmoad), which means that the therapy not only reduces pain, but is fundamentally effective in delaying further development of the disease.

As the global population ages, Kolon has rosy expectations for the osteoarthiritis treatment market. Consulting firm L.E.K. estimated that Invossa could reach sales of $5.5 billion a year in the United States alone if it does receive the Dmoad label, and $3.2 billion even if it fails to. In Korea, 1,500 patients have been treated with Invossa since its launch in November, a record the company deems impressive for a new medicine, as doctors can be hesitant to prescribe them.

BY SONG KYOUNG-SON [song.kyoungson@joongang.co.kr]