[THE INVESTOR] Kolon TissueGene CEO Lee Woo-sok expressed confidence in making its gene threapy candidate Invossa a game changer in the osteoarthritis treatment market, following the US FDA’s approval to begin late-stage clinical trials last week.
Invossa is Kolon TissueGene’s most valuable pipeline asset that the company and its affiliate Kolon Life Science have spent 19 years developing.
Kolon TissueGene CEO Lee Woo-sok
“We will start dosing the first patient in the phase 3 trials between September and October, aiming to file a marketing authorization application in the US in 2021,” Lee said at a press conference in Seoul on July 10.
The clinical studies are designed to demonstrate significant pain and functional improvement for patients diagnosed with knee osteoarthritis, one of the most common sources of pain and disability in the elderly.
“A single injection of Invossa could offer longer -- more than two years -- pain relief than existing therapies,” Lee said.
The company expects that the drug candidate will fill a long-unmet medical gap for patients living with moderate osteoarthritis when the joint space between knee bones starts reducing, causing pain while walking.
Over the counter pain meds like Tylenol and steroid injections are most often prescribed for mild level of the disease while knee replacement surgery is commonly indicated for severe osteoarthritis.
“Invossa will help improve the quality of life of patients with moderate osteoarthritis who live for 10 to 15 years without any tailored treatment while severity increases from minor to severe,” he said.
The company has also designed the final stage clinical programs for Invossa to achieve a Disease Modifying Osteoarthritis Drug, or DMOAD, designation.
Winning the label means that the potential drug has proved that it either halts, reverses or delays cartilage degradation in the trials.
“We are confident that Invossa will be granted the DMOAD designation as we will have sufficient data from the trials on 1,020 patients at over 50 clinical sites across the US. Two years of dosing period and world-class clinical operators which will work with us for the trials will bring sound results,” the CEO said.
Kolon said the drug‘s peaks sales are estimated to be worth of US$5.5 billion in the US alone if it gains the DMOAD label. Only with FDA approval as a treatment of pain and functional improvement, the figure will drop to US$3.2 billion.
In Korea, Invossa was granted approval by the Ministry of Food and Drug Safety for domestic sales in July last year but only got authorization for use in pain relief and function improvement although it was largely expected to offer breakthrough enhancement in joint structure.
Back then, Kolon pledged that the arthritis treatment will demonstrate its efficacy in joint improvement through clinical trials in the US.
“Some people criticize that Invossa will be just an expensive pain killer if it doesn’t prove its improvements in joint structure. But global drug makers are also trying to develop such a pain relief treatment for moderate knee osteoarthritis. That shows how important the drug is to the industry,” Lee added. Currently, Merck Serono, Pfizer which partnered with Eli Lilly, Regeneron and Teva are working on their respective drug candidates.
By Park Han-na (email@example.com)