KLS-2031 for Lower Back Nerve Pain

No longer recruiting at 1 trial location

Overseen By Kolon Life Science

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Kolon Life Science

Disqualifiers: Diabetic neuropathy, Rheumatoid arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, KLS-2031, to determine its safety and effectiveness for individuals with neuropathic pain from lumbosacral radiculopathy (nerve pain in the lower back and legs). Participants will receive a low, medium, or high dose of the treatment, or a placebo (a dummy treatment with no active ingredients). The trial seeks individuals who have experienced nerve pain in one or both legs for at least six months, with pain worsening at night or during rest. The goal is to assess whether KLS-2031 can reduce their pain and identify the optimal dose for future studies. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that KLS-2031 is just beginning human testing. It aims to alleviate neuropathic pain, which results from nerve damage. Earlier studies have found that KLS-2031 can improve pain signal management and reduce swelling in the body.

While detailed safety information for humans isn't widely available yet, other ongoing studies are assessing its safety and tolerance over time. Researchers are closely monitoring participants' reactions to the treatment and any side effects. Since this trial is in its early stages, researchers are still gathering basic safety information. Early trials typically focus on ensuring treatments are safe before evaluating their effectiveness.

For those considering joining this trial, it's important to know that researchers prioritize safety at this stage. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for neuropathic pain from lumbosacral radiculopathy, like NSAIDs or opioids, focus on reducing inflammation or blocking pain signals temporarily. But KLS-2031 is different because it utilizes a viral vector to deliver therapeutic genes directly to the affected area. Unlike typical medications, this gene therapy approach targets the underlying cause of nerve pain by potentially altering the way pain signals are processed. Researchers are excited because this could lead to more sustained pain relief with fewer side effects compared to conventional drugs.

What evidence suggests that this trial's treatments could be effective for analgesic activity?

Research shows that KLS-2031, which participants in this trial may receive, may help with nerve pain by addressing cell damage and inflammation. Studies have found that KLS-2031 can balance nerve signals, reducing the overactivity that causes pain. In animal studies, this treatment corrected nerve signal problems in certain parts of the spinal cord. Early results suggest it could be a good option for people with specific types of nerve pain. Although research in humans continues, the mechanism of KLS-2031 gives researchers hope for its potential. ^{1 2 3 4 6}

Who Is on the Research Team?

Todd Bertoch, MD

Principal Investigator

JBR Clinical Research

Are You a Good Fit for This Trial?

Inclusion Criteria

The subject must be willing to provide written informed consent for study participation including the 1-year double-blind treatment period and 1-year, open-label, long-term extension period. Informed consent must be obtained before any screening activities are conducted.

The subject must have a body mass index of ≤35 kg/m2.

The subject must have a diagnosis of pain due to LSR.

Exclusion Criteria

Note: Any question regarding the acceptability of the etiology of the neuropathic pain should be discussed with the medical monitor.

You have narrowing in the lower back (lumbar stenosis) that causes pain only when you walk. If your MRI shows narrowing but your pain is not only when walking, you can still participate.

You have difficulty accurately identifying and describing your own pain in different parts of your body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of KLS-2031 or placebo via transforaminal epidural injection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

104 weeks

Multiple visits at Week 1, 2, 4, 12, 26, 52, 78, 104

What Are the Treatments Tested in This Trial?

Interventions

• KLS-2031
• Placebo

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 2 Interventions

Dose 3 (high dose: 1×1013 VG/500 μL solution) or Placebo

Group II: Cohort 2 Experimental Treatment 2 Interventions

Dose 2 (medium dose: 1×1012 VG/500 μL solution) or Placebo

Group III: Cohort 1 Experimental Treatment 2 Interventions

Dose 1 (low dose: 1×1011 VG/500 μL solution) or Placebo

Who Is Running the Clinical Trial?

Kolon Life Science

Lead Sponsor

Trials

9

Recruited

3,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7378317/

AAV-Mediated Combination Gene Therapy for Neuropathic Pain These data indicate that KLS-2031 improves multiple aspects (i.e., apoptosis and neuroinflammation) contributing to the pathophysiology of NP. Figure 5 ...

2. delta.larvol.com delta.larvol.com/Products/?ProductId=bfea279f-e7f8-485c-9871-a62c0ca03569

KLS-2031 / Kolon Life Sci Based on these results, KLS-2031 could be a promising therapeutic option for PDPN." Gene therapy • CNS Disorders • Pain • Peripheral Neuropathic Pain • IL10.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1526590023004686

Combination Gene Delivery Reduces Spinal Cord ... Results showed that KLS-2031 administration restored excessive excitatory transmission and inhibitory signals in substantia gelatinosa neurons. Moreover, KLS- ...

4. kolon.com kolon.com/en/media/newsDtl?detailsKey=8350

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

5. synapse.patsnap.com synapse.patsnap.com/drug/46f43d19e68a471aba196cef2b3bd960

KLS-2031 - Drug Targets, Indications, Patents Results showed that KLS-2031 administration restored excessive excitatory transmission and inhibitory signals in substantia gelatinosa neurons. Moreover, KLS- ...

6. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/kls-2031-kolon-life-science-radiculopathy-likelihood-of-approval/

KLS-2031 by Kolon Life Science for Radiculopathy KLS-2031 is under clinical development by Kolon Life Science and currently in Phase II for Radiculopathy. According to GlobalData, Phase II ...