Consano Bio’s Platelet-Derived Biologic May Ease Chronic Sciatica, New Study, Advancing RCT
Nonclinical findings showed the investigational therapy reduced inflammation, tissue damage and pain sensitivity while promoting cellular repair, supporting its ongoing Phase 1 trial.
Key Points
- Nonclinical research found that C-1101 affected inflammatory, cellular repair and growth pathways associated with chronic sciatica.
- C-1101 reduced pain sensitivity and markers of nerve inflammation in a mouse model of neuropathic pain.
- The platelet-derived biologic is being evaluated in a randomized, double-blind Phase 1 trial.
Consano Bio has published peer-reviewed nonclinical research evaluating C-1101 for chronic painful lumbosacral radiculopathy (LSR), commonly known as chronic sciatica. The study appeared in Frontiers in Bioengineering and Biotechnology.
C-1101 is an investigational, platelet-derived multi-protein biologic. It contains cytokines, growth factors and matrix proteins intended to modulate inflammation and support cellular repair at the site of nerve injury.
Chronic sciatica results from damage or irritation of spinal nerve roots in the lower back. It can cause pain, numbness and weakness that radiate from the spine into the leg. There are currently no FDA-approved pharmaceutical treatments specifically for chronic sciatica.
Nonclinical Findings
The research combined laboratory studies in sheep disc cells with an in vivo mouse model of paclitaxel-induced neuropathic pain:
- C-1101 increased cytokine release in annulus fibrosus and nucleus pulposus sheep disc cells, including both pro-inflammatory and anti-inflammatory mediators.
- The therapy downregulated interferon signaling and extracellular matrix pathways in disc cells.
- C-1101 upregulated cell cycle and replication pathways, indicating potential effects on cell growth.
- Inflammatory pathways, including interferon gamma signaling, were downregulated in dorsal root ganglia.
- In mice, systemic C-1101 reduced neuropathic cool allodynia, a measure of pain sensitivity, at both doses tested.
- The higher dose reduced markers of macrophage and microglial activation in sciatic nerves.
- Transient increases in cytokines were also observed, indicating that the therapy produced a mixed inflammatory response that requires further study.
“Chronic painful LSR, or chronic sciatica, is a condition with no FDA-approved pharmaceutical treatment, and patients often live with it for years,” said Jennifer Schmitke, Ph.D., Chief Operating Officer and Head of Research and Development of Consano Bio. “In LSR, the pain is actually caused by injury and inflammation at the nerve root in the affected region of the spine. Across in vitro and in vivo studies, C‑1101 demonstrated immunomodulatory and and cellular repair and regrowth activity These data support the potential for C-1101 to modify the underlying disease of LSR by treating the source of the pain. These findings further reinforce why we chose chronic painful LSR for our first study in patients.”
“This initial work combines in vitro and in vivo work to interrogate the biological activity of C‑1101. The functional reduction in pain sensation with C‑1101 was observed in the murine peripheral neuropathy model, indicating potential therapeutic efficacy. C‑1101 induced a mixed inflammatory response, with secretion of both pro- and anti-inflammatory cytokines in cultured cells, warranting further investigation of the mechanism of action,” said Lynn M. Pezzanite, DVM, MS, Ph.D., Assistant Professor of Cellular and Molecular Biology in the Department of Clinical Sciences, Colorado State University College of Veterinary Medicine and Biomedical Sciences, and corresponding author of the publication.
Phase 1 Clinical Study
Consano Bio is evaluating C-1101 in a randomized, double-blind Phase 1 study identified as C-1101-101, or NCT07264270. Participants with chronic painful LSR will each receive a single epidural injection.
The epidural delivery is intended to provide concentrated proteins directly to the site of nerve injury. The FDA has granted C-1101 Fast Track designation.
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