Kolon Life Science registers Brazilian patent for KLS-2031, a treatment for neuropathic pain, as a “compound for treating pain”

▷Patented gene combination for blocking excessive pain signals (GAD65) and regulating inflammation (IL-10)

▷Brazil rapidly emerging as a CGT research and production hub in Central and South America... Patents registered in 11 countries

Kolon Life Science (CEO Kim Sun-jin) announced today (23rd) that a patent for a ‘pain treatment compound’ related to KLS-2031, a gene therapy for neuropathic pain currently under development by the company, has recently been registered in Brazil.

KLS-2031 is designed to carry three therapeutic genes that can produce a synergistic effect when combined with a recombinant adeno-associated virus (rAAV). This patent covers a compound for pain relief or treatment through a combination of two genes, glutamic acid decarboxylase 65 (GAD65) and interleukin 10 (IL-10), for the purpose of blocking excessive pain signals and regulating inflammation.

Through research and development, Kolon Life Science confirmed that recombinant adenovirus carrying a combination of GAD65 and IL-10 genes showed superior and long-lasting pain relief and therapeutic effects compared to single genes or other gene combinations, and secured a patent for a ‘composition for pain treatment’ based on these results.

According to the Korea Health Industry Development Institute, Brazil's pharmaceutical market is considered the largest in Latin America. The local market is expected to grow at a compound annual growth rate (CAGR) of 6.5% until 2027, reaching $33.5 billion (approximately 4.7 trillion won). Brazil has also recently emerged as a hub for cell and gene therapy (CGT) research and production in Latin America, with government support, investment from multinational companies, and the research capabilities of medical institutions combining to drive continued market expansion in the future.

Kolon Life Science is continuously securing rights to protect KLS-2031 technology in the global market, filing more than 30 patents related to KLS-2031 in 15 countries around the world. This patent for this pain treatment compound has been registered in 11 countries, including Brazil, South Korea, USA, Japan, Europe, China, and India.

Kim Sun-jin, CEO of Kolon Life Science, said, “This patent registration is significant in that it recognizes our technological capabilities in Brazil, a major CGT market in Central and South America. In addition to the patent for this pain treatment compound, we plan to conduct additional clinical trials and expand indications based on the registration of related patents, research results, and clinical analysis results.”

KLS-2031 is capable of multi-target action by incorporating GAD65, IL-10, and glial cell-derived neurotrophic factor (GDNF), and regulates intractable and chronic pain by normalizing excessively amplified pain signals, protecting neurons, and improving neuroinflammation. The research results related to this patent were published in the international academic journal Molecular Therapy Clinical and Development in 2020, and the results of preclinical experiments using pain models were also published in the Journal of Pain, a renowned international academic journal in the field of pain, in July 2023.

Meanwhile, Kolon Life Science initiated a Phase 1/2a clinical trial in the US in 2020 to explore the safety and efficacy of KLS-2031. According to the final results report received in June 2024, the primary objectives of the clinical trial, namely the tolerability and safety of the drug, were proven. The company is currently conducting a long-term follow-up study to collect long-term safety and tolerability data up to five years post-administration.