KLS-2031 / Kolon Life Sci - LARVOL DELTA

Innovative Approach for Diabetic Foot Neuralgia with KLS-2031, Novel Triple-genetic AAV, Produced Sustanined Therapy (Neuroscience 2025) - "Therapeutic efficacy was compared among pregabalin, duloxetine,and KLS-2031 treatment groups. Histological analyses revealed that KLS-2031 mitigated neuroinflammatory responses in both peripheral and central nervous tissues.ConclusionsKLS-2031, a triple-genic AAV-based gene therapy, demonstrated potent and durable analgesic effects in preclinical models of PDPN, independent of sex or glycemic control. These findings support the therapeutic potential of KLS-2031 as an attractive intervention for PDPN and further clinical trial is being prepared."

CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • IL10

Innovative gene therapy combats diabetic neuropathy (NeuPSIG 2025) - "KLS-2031, combinational gene therapy to achieve long-term analgesic effects, showed comparable and long-lasting efficacy in controlling pains in PDPN animal models with supporting histo-pathologic studies. Based on these results, KLS-2031 could be a promising therapeutic option for PDPN."

Gene therapy • CNS Disorders • Pain • Peripheral Neuropathic Pain • IL10

Innovative gene therapy combats diabetic neuropathy (NeuPSIG 2025) - "KLS-2031, combinational gene therapy to achieve long-term analgesic effects, showed comparable and long-lasting efficacy in controlling pains in PDPN animal models with supporting histo-pathologic studies. Based on these results, KLS-2031 could be a promising therapeutic option for PDPN."

Gene therapy • CNS Disorders • Pain • Peripheral Neuropathic Pain • IL10

Kolon Life Science, Pain Treatment 'KLS-2031' Registered as Patent in Brazil [Google translation] (HIT News) - "Kolon Life Science...announced on the 23rd that the patent for the 'pain treatment composition' of 'KLS-2031', a neuropathic pain gene therapy drug currently under research and development by the company, was recently registered in Brazil....According to the company, this patent includes a composition for pain relief or treatment through a combination of two genes, GAD65 and IL-10, for the purpose of blocking excessive pain signals and controlling inflammation."

Patent • Pain

Kolon Life Science Announces Nonclinical Results of KLS-2031 Diabetic Peripheral Neuropathy at IASP [Google translation] (BioNews) - "Kolon Life Science announced on the 28th that it had presented the results of a non-clinical efficacy evaluation of its neuropathic pain gene therapy candidate, 'KLS-2031 (development code name),' for diabetic peripheral neuropathy as a poster at the 'International Association for the Study of Pain 2024...held in Amsterdam, the Netherlands....According to the study, the threshold for avoidance response to pain stimuli in the KLS-2031-administered group was statistically significantly increased compared to the placebo (saline)-administered group, and recovered to a similar level as the normal animal group. This is interpreted to mean that after KLS-2031 administration, the normal animal group no longer felt pain to weak stimuli that did not cause pain. In addition, KLS-2031 was confirmed to have a long-term pain control effect with a single administration."

Preclinical • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

KLS-2031 as a new multimodal gene therapy for painful diabetic peripheral neuropathy (IASP 2024) - "Based on these results, the AAV-mediated gene combination approach KLS-2031 has a strong analgesic effect and can restore the pathophysiology of neuropathic pain. The efficacy of KLS-2031 is attributed to its multi-target approach, which simultaneously modulates several pathologies in the DRG and spinal cord (SC). These results suggest that KLS-2031 is a novel, effective, and promising therapy for PDN."

Gene therapy • Diabetes • Diabetic Neuropathy • Gene Therapies • Inflammation • Metabolic Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • CASP3 • GFAP

Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy (clinicaltrials.gov) - P1/2 | N=18 | Completed | Sponsor: Kolon Life Science | Active, not recruiting ➔ Completed | Trial primary completion date: Oct 2022 ➔ Oct 2023

Trial completion • Trial primary completion date • Neuralgia • Pain

A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study (clinicaltrials.gov) - P=N/A | N=5 | Active, not recruiting | Sponsor: Kolon Life Science | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed

Kolon Life Science Receives US Phase 1/2a CSR for Neuropathic Pain Treatment KLS-2031 [Google translation] (Hankyung) - P1/2 | N=18 | NCT04238793 | Sponsor: Kolon Life Science | "Kolon Life Science 's gene therapy candidate (KLS-2031) for treating neuropathy has once again proven its safety in phase 1/2a clinical trials. Kolon Life Science announced on the 26th that it has received the final report (CSR) for the US phase 1/2a clinical trial of 'KLS-2031', a gene therapy for neuropathic pain....This report included additional data collected up to week 104 after patients who received KLS-2031 had their double blinding lifted at week 52 of administration. Kolon Life Science emphasized that the primary objective of the clinical trial, drug tolerance and safety, had been proven up to week 104 of administration."

P1/2 data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Kolon Life Science’s gene therapies win patents in India (Korea Biomedical Review) - "Kolon Life Science said Wednesday that its patent on alleviating or treating pain for neuropathic pain gene therapy, KLS-2031, and a patent on a recombinant vaccinia virus for anti-cancer gene therapy, KLS-3021, won registration in India."

Patent • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Kolon Life Science announces interim results of Phase 1/2a neuropathic pain treatment [Google translation] (docdocdoc.co.kr) - P1/2 | N=18 | NCT04238793 | Sponsor: Kolon Life Science | "Kolon Life Science announced on the 31st of last month that it had received the interim results report of the U.S. phase 1/2a clinical trial for lumbar sacral radiculopathy (LSR) pain for 'KLS-2031'....According to Kolon Life Science, there were no serious adverse events (SAEs) that occurred up to the 52nd week of the double-blind treatment period out of the total 104 weeks of study....Kolon Life Science evaluated the interim results as having secured excellent tolerability and safety of KLS-2031. However, in the case of effectiveness, which is the secondary evaluation indicator, statistical significance was not secured....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), around the first half of 2024."

P1/2 data • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Kolon Life Science registers Indian patent for KLS-2031 ‘Composition for treating pain’ [Google translation] (Medifonews) - "Kolon Life Science...announced today that a patent for a 'pain treatment composition' related to KLS-2031, a gene treatment for neuropathic pain that the company is researching and developing, has recently been registered in India....This patent is about a pain relief or treatment composition through a combination of two genes, Glutamic Acid Decarboxylase 65 (GAD65) and Interleukin 10, IL-102, for the purpose of blocking excessive pain signals and controlling inflammation....This ‘pain treatment composition’ patent has been registered in nine countries, including India, Korea, the United States, Japan, Europe, and China."

Patent • CNS Disorders • Lumbar Back Pain • Neuralgia • Pain • Peripheral Neuropathic Pain

Combination gene delivery reduces spinal cord pathology in rats with peripheral neuropathic pain. (PubMed, J Pain) - "PERSPECTIVE: Our study demonstrated that KLS-2031, a combination gene therapy delivered by transforaminal epidural injection, not only mitigates neuroinflammation, but also improves SC neurophysiological function, including excitatory-inhibitory balance. These findings support the potential of KLS-2031 as a novel modality that targets multiple aspects of the complex pathophysiology of neuropathic pain."

Journal • Preclinical • Gene Therapies • Immunology • Inflammation • Neuralgia • Pain • Peripheral Neuropathic Pain • IL10

Combination gene delivery reduces spinal cord pathology in rats with peripheral neuropathic pain (Neuroscience 2022) - "KLS-2031 mitigated neuroinflammation in the SC by regulating microglia and astrocytes. Collectively, KLS-2031 effectively suppressed the central sensitization of pain signals and inflammation in the SC of a NP model and offers a potentially new therapeutic approach for NP."

Preclinical • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • GFAP • IL10

A Long-term, 3-Year, Follow-up Study for Patients Completing the KS-GIG-001-01 Study (clinicaltrials.gov) - P1/2 | N=8 | Enrolling by invitation | Sponsor: Kolon Life Science

New P1/2 trial • Neuralgia • Pain

Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy (clinicaltrials.gov) - P1/2 | N=18 | Active, not recruiting | Sponsor: Kolon Life Science | Recruiting ➔ Active, not recruiting

Enrollment closed • Neuralgia • Pain

Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy (clinicaltrials.gov) - P1/2; N=18; Recruiting; Sponsor: Kolon Life Science; Trial completion date: Nov 2022 ➔ Sep 2023; Trial primary completion date: Nov 2021 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • Neuralgia • Pain • Peripheral Neuropathic Pain • MRI

Kolon 'KLS-2031' clinical cruise in progress… World stage re-challenge [Google translation] (Yakup Shinmoon) - "At Bioplus interphex Korea 2020, which was held online on the 25th, Kolon Life Sciences Executive Director Kim Soo-jeong gave a presentation on the theme of 'KLS-2031: AAV Mediated Neuropathic Pain Treatment.'"

Clinical data • Neuralgia • Pain

AAV-Mediated Combination Gene Therapy for Neuropathic Pain: GAD65, GDNF, and IL-10. (PubMed, Mol Ther Methods Clin Dev) - "Furthermore, KLS-2031 mitigated the neuroinflammation, neuronal cell death, and dorsal root ganglion hyperexcitability induced by the spared nerve injury. These results suggest that KLS-2031 represents a promising therapeutic option for refractory neuropathic pain."

Journal • Immunology • Neuralgia • Pain • IL10

Kolon begins testing gene therapy for neuropathic pain in US [Google translation] (Korea Biomedical Review) - "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....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."

Trial completion date • Trial status • Back Pain • CNS Disorders • Lumbar Back Pain • Neuralgia • Pain • Peripheral Neuropathic Pain

Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy (clinicaltrials.gov) - P1/2; N=18; Recruiting; Sponsor: Kolon Life Science; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Kolon’s Life and Inbosa will reappear as gene therapy for [Google translation] (thebell) - "Kolon Life Sciences announced that it will start Phase 1 and Phase 2a clinical trials of the KLS-2031 (development name) for neuropathic pain....'We will be conducting Phase I and Phase IIa clinical trials aimed at evaluating the safety and efficacy of KLS-2031 through two clinical institutions in the US, starting with the first patient visit in March'...Kolon Life Sciences, which received a product license from the Ministry of Food and Drug Safety in July 2017, was revoked the license in July last year...Kolon Tissuezine is reported to be submitting supplemental data to FDA this month to resume phase III clinical trials."

FDA event • New P1 trial • New P2a trial • Trial initiation date

Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy (clinicaltrials.gov) - P1/2; N=18; Not yet recruiting; Sponsor: Kolon Life Science

Clinical • New P1/2 trial