Kolon Life Science said Monday it has started the administration of an experimental gene therapy KLS-2031 to the first patient to treat neuropathic pain in the phase-1/2a trial in the U.S.
KLS-2031 is a candidate for the first-in-class drug for the treatment of lumbosacral radiculopathy, a pain syndrome caused by compression or irritation of nerve roots in the lower back. The U.S. Food and Drug Administration has granted the investigational drug a fast track designation, which can speed up the development of the drug that may treat the life-threatening disease and address unmet medical needs.
The company said the trial would take place at two clinical institutions in the U.S. and end in 2023. Researchers plan to administer the drug once to 18 patients and observe the progress for 24 months. The company also said it would begin the first dose to the second patient within April.
Existing treatments for neuropathic pain are analgesics that cannot cure the disease fundamentally and do not have a lasting effect. KLS-2031 has combined three therapeutic genes -- GAD65, GDNF, and IL-10. The new gene therapy has a more prolonged analgesic effect than existing treatments for neuropathic pain, and it may treat the disease fundamentally, Kolon Life Science said.
“With a successful clinical trial on this pipeline, we will strengthen our position as a cell gene therapy specializing company,” CEO Park Moon-hee said. “As the drug was granted the fast track designation, we will make it a fundamental treatment and a globally selling new drug,”
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