Kolon Life Science said Monday it obtained the U.S. Food and Drug Administration’s investigational new drug (IND) approval to conduct a phase-1/2a clinical trial on KLS-2031, a gene therapy for neuropathic pain.
KLS-2031 is the next pipeline of osteoarthritis cell gene therapy Invossa-K. Rather than following the tablet form of conventional neuropathic pain treatments, the company chose an injection form for KLS-2031.
KLS-2031 has two adeno-associated virus (AAV) vectors and three therapeutic genes – GAD65, GDNF, and IL-10.
The first delivery by the GAD 65 gene suppresses the pain signal to the brain, and the second one by the GDNF and the IL-10 gene protects the injured nerve and prevents inflammation.
Kolon developed it as a single topical injection to make analgesic effects last long. The investigational drug targets patients with neuropathic pain who failed in conventional treatments.
With the FDA’s IND approval, the company plans to start the phase 1/2a study, within this year, on KLS-2031 for 18 people at two clinical institutions in the U.S. for 24 months.
“The FDA’s approval for clinical trials for KLS-2031 will be an opportunity for us to be recognized as a gene therapy specializing company in the global market and promote Korea’s advanced gene research capabilities in the biotech sector,” said Lee Woo-suk, CEO of Kolon Life Science.