Kolon Life Science secures Brazilian patent for neuropathic pain gene therapy candidate

2025-04-23     Kim Ji-hye

Korea’s Kolon Life Science said Wednesday it has secured a Brazilian patent for KLS-2031, its experimental gene therapy for neuropathic pain. The patent covers a multi-gene composition designed to silence pain signals and control inflammation.

The therapy uses a recombinant adeno-associated virus (rAAV) vector—a common gene delivery tool in gene therapy that acts like a molecular courier, transporting therapeutic genes into targeted nerve cells.

Kolon Life Science has secured a Brazilian patent for its gene therapy candidate KLS-2031, expanding global IP protection for the neuropathic pain treatment. (Courtesy of Kolon Life Science)

According to Kolon, KLS-2031 delivers three pain-modulating genes. These include glutamic acid decarboxylase 65 (GAD65), which boosts levels of the inhibitory neurotransmitter GABA to calm overactive nerves, and interleukin-10 (IL-10), an anti-inflammatory cytokine that helps suppress immune-driven pain. 

The company said its preclinical studies showed the GAD65 and IL-10 gene combo provided longer-lasting and more effective pain relief than either gene alone.

The Brazilian patent adds to Kolon’s global intellectual property portfolio for KLS-2031, now registered in 11 countries including the U.S., Japan, Korea, and China, according to Kolon. 

Kolon also noted that the therapy includes glial cell line-derived neurotrophic factor (GDNF), a protein known to support neuron survival and repair, targeting chronic nerve damage and inflammation at the source.

The company launched a phase 1/2a trial in the U.S. in 2020 to evaluate the safety and tolerability of KLS-2031. A final report received in June 2024 confirmed the therapy was well tolerated, Kolon said, adding that long-term follow-up studies are ongoing to track five-year safety outcomes.

Kolon Life Science CEO Kim Sun-jin called the Brazilian patent particularly meaningful given the country’s growing role in gene therapy development. Brazil, the largest pharmaceutical market in Latin America, is projected to reach $33.5 billion by 2027, and is emerging as a regional cell and gene therapy hub, the company said, citing government funding and increased foreign investment.

“We plan to build on this patent with additional clinical trials and new indications,” Kim said.

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