Kolon Life Science announced on the 31st that it has received the interim results report of the U.S. phase 1/2a clinical trial for lumbar sacral radiculopathy (LSR) pain for KLS-2031, a neuropathic pain gene therapy under research and development.
Kolon Life Science headquarters building / Provided by Kolon Life Science
KLS-2031 is a neuropathic pain treatment that is loaded with three types of therapeutic genes (GAD65, IL-10, GDNF) in recombinant adeno-associated virus (rAAV) for the purpose of normalizing over-amplified pain signals, protecting nerve cells, and improving neuroinflammation. It is a gene therapy.
This clinical trial was the first to be conducted on humans, and was approved by the U.S. Food and Drug Administration (FDA) in 2019, and was conducted at two institutions in the U.S. for 2 years and 6 months from April 16 of the following year to October 5 of last year. It was conducted on people.
Subjects were randomly assigned to three cohorts divided into low, medium, and high doses of KLS-2031 and a placebo control group. The clinical trial was conducted with a single transforaminal epidural injection administered to the area around the subject’s target dorsal root ganglion (DRG).
According to the report, out of the total study period of 104 weeks, there were no serious adverse events (SAEs) that occurred until the 52nd week of the double-blind treatment period. The number of subjects who experienced adverse events (TEAEs) after treatment was 16 in total, including 2 in the low-dose group of KLS-2031, 4 in the medium-dose group, 4 in the high-dose group, and 6 in the placebo group.
Among the subjects who experienced adverse reactions, there were 2 drug-related adverse reactions (TEAEs) after treatment. An increase in alanine aminotransferase (ALT) was observed in one subject in the high-dose group, but it was reported to be mild and recovered within 2 weeks from the onset of symptoms. Additionally, one subject in the placebo group experienced headache and hyperhidrosis.
Kolon Life Science evaluated that it had secured excellent tolerability and safety of KLS-2031, the primary objective of the clinical trial, through the U.S. phase 1/2a clinical trial. Regarding efficacy, which is a secondary objective, statistical significance could not be secured due to patient dropout due to the coronavirus pandemic, etc., but a clear analgesic effect was observed in the medium and high dose groups compared to the low dose.
Following this interim results report, Kolon Life Science plans to announce the final research results report, including the results of the total research period (104 weeks), in the first half of 2024. In addition, a long-term follow-up study is being conducted to secure long-term safety and tolerability data up to 5 years after KLS-2031 administration.
2023-10-31 10:46:00
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