Kolon TissueGene, the developer of Invossa (TG-C), a gene therapy to treat knee osteoarthritis (OA), has resumed patient dosing in its U.S. Phase 3 clinical trial, two years after suspension caused by regulatory revocation in Korea due to a controversial ingredient mix-up during development.

The drug kicked out of the Korean market in 2019 was given a second chance with the U.S. FDA’s nod for continuous research, which could affect the ongoing review of whether the company should be delisted from the Kosdaq market. Shares are currently suspended.

Kolon Life Science said on Tuesday its U.S. affiliate Kolon TissueGene resumed the pivotal TG-C study at Source Healthcare in Santa Monica, CA this week, and the trial will be completed by 2023 with 1,020 subjects involved from over 80 university hospitals and clinics across the U.S.

This therapy, if authorized, will be a game changer for OA patients worldwide, said Dr. Han Sung-soo, CEO of Kolon TissueGene.

TG-C is a first-in-class cell and gene therapy targeting OA of the knee through a single intra-articular injection. In addition to significant pain and function improvements, the company designed the TG-C study to achieve a disease modifying osteoarthritis drug (DMOAD) designation. No treatment has been recognized as DMOAD worldwide.

Marketing approval of Invossa was canceled by the Ministry of Food and Drug Safety in May 2019 as authorities found its marketing approval was based on false documents, where the cells in the second fluid of the drug were kidney-derived cells instead of cartilage-derived ones. The company is in a legal fight with the government to nullify the cancellation.

In the aftermath of the revocation, the FDA suspended the planned Phase 3 clinical trial in the U.S., but the mood has changed this year after the FDA’s approval of resuming the clinical trial in April last year, approval for a separate Phase 2 clinical trial for patients with hip osteoarthritis on Dec. 3, and actual patient dosing on Dec. 28.

By Kim Si-gyun and Minu Kim

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]