Kolon Life Science Highlights Next-Generation Treatment Option for Diabetic Neuropathy

▶  KLS-2031, presented at U.S. ‘SfN 2025’ , demonstrates long-term efficacy in preclinical PDPN studies

▶  Successive positive evaluations at international conferences, draws global researchers' attention to next-generation therapy 

Kolon Life Science (CEO Kim Sun-jin) is strengthening its global position as a developer of next-generation therapeutics for diabetic neuropathy. 

Kolon Life Science announced it will present the latest preclinical research results for its gene therapy candidate KLS-2031 in a poster presentation at the Society for Neuroscience (SfN 2025) conference opening in San Diego, USA, on November 15 (local time). 

This study evaluated the pain-relieving effects and mechanism of action of KLS-2031 in a diabetic peripheral neuropathy (PDPN) model. The results confirmed a long-lasting analgesic effect compared to existing treatments. 

PDPN is a representative chronic complication of diabetes, occurring due to nerve damage caused by prolonged hyperglycemia. Primary symptoms include numbness in the hands and feet, sensory abnormalities, and pain. Severe symptoms can significantly restrict daily activities. This condition markedly reduces patients' quality of life and increases socioeconomic burdens. No cure is currently available, however, and existing medications carry concerns about adverse side effects, leading to a consistent need for new treatment options. 

The Kolon Life Science research team injected the gene therapy candidate KLS-2031 into an experimental mouse model with diabetes-induced neuropathy and evaluated pain responses. The results showed that the group receiving a single dose of KLS-2031 demonstrated stronger and longer-lasting pain relief effects compared to groups receiving daily doses of the standard-of-care (SoC) treatments ‘pregabalin’ and ‘duloxetine,’ which are currently widely used for diabetic neuropathy.

While pregabalin and duloxetine are effective at reducing pain, they require daily administration and carry concerns about side effects and drug dependence. In contrast, KLS-2031 demonstrated long-lasting effects with just a single dose, suggesting its potential as a next-generation treatment. 

In particular, the pain-relieving effect of KLS-2031 was demonstrated to persist in diabetic models receiving concomitant insulin therapy, regardless of the degree of blood glucose control achieved by insulin. This maximizes the clinical relevance of the preclinical data. It suggests that KLS-2031 is a viable treatment option for patients undergoing blood glucose control in real-world clinical settings, irrespective of insulin administration status. 

Additionally, anti-inflammatory effects were observed by regulating the immune cell environment activated within the dorsal root ganglion (DRG) and spinal cord, thereby creating an immune environment similar to that of the normal group. This demonstrates that KLS-2031 can act as a therapeutic agent that regulates physiological and immunological responses involved in pain generation, going beyond simple analgesic action.

KLS-2031 is a recombinant adeno-associated virus (rAAV)-based gene therapy designed to simultaneously express three key genes crucial for suppressing neuroinflammation and regulating pain signaling pathways: GAD65, GDNF, and IL-10. This study suggests that KLS-2031, with just a single administration, provides longer-lasting pain relief and holds the potential to become a next-generation treatment option that overcomes the limitations of existing drug therapies. 

Kim Sun-jin, CEO of Kolon Life Science, stated, “There was significant interest in KLS-2031 from global pharmaceutical companies and researchers at recent international conferences,” adding, “We are actively pursuing follow-up preclinical studies for additional indications, joint development, and discussions on clinical entry through technology exports.”

He further added, “Particularly since we have already established safety for spinal disorders in U.S. clinical trials, we will complete the identification of optimal indications and dosing regimens and continue to focus our R&D capabilities on developing patient-centered gene therapies.”

The Society for Neuroscience (SfN) conference is the world's largest academic gathering in neuroscience, attracting over 30,000 researchers from more than 70 countries. Kolon Life Science plans to continuously share its research achievements on global academic stages, and strengthen its global collaboration network to advance the clinical development and expand the indications for KLS-2031.