Kolon Life Science Receives Final Report for KLS-2031 Phase 1 and 2a Clinical Trials

Kolon Life Science announced on the 27th that it has received the final report of the US Phase 1/2a clinical trial for KLS-2031, a gene therapy under development for neuropathic pain, targeting lumbosacral radiculopathy (LSR) pain.

Kolon Life Science Headquarters Building Exterior [Photo by Kolon Life Science]

This report includes data additionally collected up to week 104 after unblinding at week 52 in patients who received KLS-2031. According to the report, KLS-2031 demonstrated the primary clinical endpoints of drug tolerability and safety up to week 104 of administration.

The secondary endpoint efficacy at week 104 showed a trend similar to the interim report at week 52. However, since the double-blind design and concomitant medication restrictions were lifted starting at week 52, the efficacy data at week 104 can only be used as supportive information.

This clinical trial was conducted over three and a half years from April 2020 to October last year at two institutions in the United States, following approval by the US Food and Drug Administration (FDA) in 2019. Eighteen subjects participated in a randomized, double-blind, placebo-controlled study. Subjects were randomly assigned to three cohorts receiving low, medium, or high doses of KLS-2031 or to a placebo group, with a single epidural injection administered via the cervical intervertebral foramen targeting the dorsal root ganglion (DRG) area.

According to the report, there was one serious adverse event (SAE) up to week 104 (benign pulmonary neoplasm), which was assessed as ‘unlikely’ to be related to the drug. Treatment-emergent adverse events (TEAEs) were reported in 2 patients in the low-dose group, 4 in the medium-dose group, 4 in the high-dose group, and 5 in the placebo group. Among these, treatment-related adverse events actually associated with the drug occurred in 2 patients. One patient in the high-dose group experienced an elevation of alanine aminotransferase (ALT), which was mild and resolved by week 4 when symptoms appeared. Additionally, one subject in the placebo group reported headache and hyperhidrosis.

Seonjin Kim, CEO of Kolon Life Science, stated, “Based on the results of this clinical trial, we are considering various development plans such as selecting the recommended Phase 2 dose (RP2D), conducting follow-up clinical trials to evaluate drug efficacy for expanded indications including postherpetic neuralgia (PHN) and diabetic peripheral neuropathy (DPN) pain, or licensing out.”