Kolon TissueGene has dosed the first patient in a Phase III clinical trial evaluating invossa for the treatment of knee osteoarthritis (OA).
The dosing follows the lifting of a clinical hold by the US Food and Drug Administration (FDA) in July this year.
The pivotal trial is expected to enrol approximately 1,020 patients at around 60 clinical sites across the US.
It aims to support the US approval of invossa for OA and will be conducted by a team of orthopedic surgeons, rheumatologists and pain specialists.
Kolon will evaluate pain and function endpoints, as well as MRI, X-ray and liquid biomarkers of invossa as part of the study.
The company also intends to examine the capability of invossa in delaying disease progression.
Depending on the success of the trial, invossa could achieve a claim for Disease Modifying Osteoarthritis Drug (DMOAD) label from the FDA.
Kolon TissueGene president and CEO Woosok Lee said: “This is an exciting step for Kolon TissueGene as we progress towards providing key clinical benefits for patients of this debilitating disease with this novel cell and gene therapy for knee osteoarthritis.”
Invossa is an investigational cell and gene therapy designed to target OA of the knee through a single intra-articular injection.
OA patients currently endure years of devastating pain and a reduced quality of life.
Kolon claims a single injection of invossa could provide the patients with over two years of productive and pain-free mobility, without the immediate need for surgery.